This study evaluates the implementation of the GETSET (Guiding Endocrine Therapy Success through Empowerment and Teamwork) pilot, a motivational interviewing (MI) intervention aimed at improving endocrine therapy (ET) adherence among patients with breast cancer.

Using the Consolidated Framework for Implementation Research (CFIR), qualitative interviews were conducted with site staff (N = 2), patients (N = 4), and counselors (N = 2).

The thematic analysis identified facilitators such as high-quality materials, ease of scheduling sessions, and effective communication among staff. However, barriers included lack of personalization and systemic issues like understaffing.

The study underscores the need to adapt implementation of behavioral interventions in a healthcare setting to improve ET adherence. As this was a process evaluation of a pilot study, future work should evaluate the barriers and facilitators to a larger clinical trial to identify if the same strategies should be refined.

To compare menopausal symptoms between tamoxifen alone and tamoxifen with ovarian function suppression (OFS) over 12 months, identifying related factors.

This prospective, observational study included 209 premenopausal patients with breast cancer on tamoxifen, recruited from Asan Medical Center, Republic of Korea. We collected demographic and clinical information from the participants' medical records and assessed menopausal symptoms using the Korean Menopause Rating Scale (MRS) at 3-, 6-, and 12-months postdiagnosis.

Of the 209 participants, 27.8% were administered tamoxifen in conjunction with OFS. Compared with the tamoxifen alone group, the tamoxifen plus OFS group had lower baseline MRS scores but higher scores at 6 and 12 months, and the scores showed a plateau within a year for both groups. Factors contributing to higher MRS scores at 6 months included the baseline MRS score (estimate, -0.326; standard error, 0.077) and addition of OFS (estimate, 6.084; standard error, 1.306; P < .001 for both). A significant interaction between OFS and prior chemotherapy was identified, with the OFS impact being significantly notable only in patients without prior chemotherapy (estimate, -6.643; standard error, 2.946; P = .025).

Addition of OFS to tamoxifen in premenopausal patients with breast cancer can exacerbate menopausal symptoms relative to those when tamoxifen is used alone, especially in patients without prior chemotherapy. Thus, personalized treatment decisions about ovarian function suppression should consider potential symptom burdens, particularly for chemotherapy-naive patients, to balance treatment efficacy and quality of life.

This review aims to investigate the issue of treatment nonadherence and to present the available strategies to improve adherence to oral treatments in breast cancer. A literature search was conducted to contextualise the issue of nonadherence, investigate the reasons behind nonadherence, and demonstrate strategies to address treatment nonadherence in breast cancer. Findings indicate that adherence rates decrease while discontinuation rates increase with increasing lengths of breast cancer treatment course. Lack of adherence is proven to be detrimental to treatment outcomes. Patients struggle to adhere to treatment due to inadequate relationships with healthcare providers, lack of information, psychological distress, and side effects. Healthcare providers should evaluate patient's experience to provide the necessary support. Following this assessment, healthcare providers may recommend interventions addressing patient knowledge, psychological distress or side effects. Treatment adherence remains an issue for oral therapeutics in breast cancer. After patient assessment, healthcare providers can offer personalised strategies to improve treatment adherence. The most crucial interventions address patient knowledge, psychological distress, and side effects.

Adjuvant endocrine therapy (AET) increases sexual health challenges for women with early-stage breast cancer. Black women are more likely than women of other racial/ethnic groups to report adverse symptoms and least likely to initiate and maintain AET. Little is known about how sexual health challenges influence patient-clinician communication and treatment adherence. This study explores facilitators of and barriers to patient-clinician communication about sexual health and how those factors might affect AET adherence among Black women with early-stage breast cancer.

We conducted 32 semi-structured, in-depth interviews among Black women with early-stage breast cancer in the U.S. Mid-South region. Participants completed an online questionnaire prior to interviews. Data were analyzed using thematic analysis.

Participants' median age was 59 (range 40-78 years, SD = 9.0). Adverse sexual symptoms hindered participants' AET adherence. Facilitators of patient-clinician communication about sexual health included female clinicians and peer support. Barriers included perceptions of male oncologists' disinterest in Black women's sexual health, perceptions of male oncologists' biased beliefs about sexual activity among older Black women, cultural norms of sexual silence among Southern Black women, and medical mistrust.

Adverse sexual symptoms and poor patient-clinician communication about sexual health contribute to lower AET adherence among Black women with early-stage breast cancer. New interventions using peer support models and female clinicians trained to discuss sexual health could ameliorate communication barriers and improve treatment adherence.

Black women with early-stage breast cancer in the U.S. Mid-South may require additional resources to address sociocultural and psychosocial implications of cancer survivorship to enable candid discussions with oncologists.

Oral endocrine therapy (OET) is recommended in prevention and treatment of hormone receptor-positive breast cancer (HR+ BC). Despite the reduced incidence, recurrence, and mortality, OET adherence is poor in this patient population. The aim of this study was to review the latest literature to identify effective interventions to improve medication adherence in patients taking OET for prevention or treatment of HR+ BC.

The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) framework was used to perform this review. We utilized PubMed, SCOPUS, EMBASE, Cochrane, and Web of Science to acquire articles using search terms including breast cancer, adherence, persistence, and acceptability. Inclusion criteria included publication in peer-reviewed journal, primary data source, longitudinal, patients on OET such as aromatase inhibitors (AIs) or selective estrogen receptor modulators (SERMs), measuring adherence, persistence, or acceptability.

Out of 895 articles identified, 10 articles were included. Majority of patients had early-stage HR+ BC. Two out of two studies incorporating technological intervention, two out of three studies with text communication-based intervention, and three out of five studies with verbal communication-based intervention reported significant improvement in OET adherence and/or persistence.

While the interventions tested so far have shown to improve OET adherence in HR+ BC patients in some studies, there is a need to design combination interventions addressing multiple barriers in this population.

This study showcases effectiveness of novel interventions to improve OET adherence and the need to further develop patient-centered strategies to benefit all patients with HR+ BC.

Using patient-reported outcomes (PROs) and more objective measures, we evaluated adherence to adjuvant palbociclib and ET in the PALLAS trial, and the impact of palbociclib on ET adherence.

The open-label, global, phase 3 PALLAS trial randomized patients with hormone receptor-positive (HR+), HER2-negative stage II-III breast cancer (1:1) to either 26 cycles of palbociclib (125 mg/day for 21 days and then 7 days off) plus adjuvant ET, versus ET alone. After 23.7 months median follow-up, palbociclib was stopped due to futility of the intervention and patients were moved to follow-up. For each cycle, daily adherence to ET was measured with study diaries; for palbociclib, study diaries and pill counts. At cycles 2, 3, 6, 12, 18 and 24, patients completed the Morisky Medication Adherence Scale-4 plus an additional item and the McHorney Adherence Questionnaire. Mean persistence was defined in months from treatment initiation to cessation.

Four thousand six hundred eighty-eight of 5796 total PALLAS participants were included. Across all cycles, mean daily ET adherence values measured by study diary were > 98.0% and did not differ between treatment arms. Mean persistence to ET was similar between arms (19.2 months for palbociclib + ET vs. 19.6 months for ET alone). However, patient-reported maximal ET adherence was higher across time for palbociclib + ET compared to ET alone (p ≤ 0.0001, modified MMAS-4; p = 0.05, McHorney).

In the PALLAS trial, addition of palbociclib did not decrease adherence to adjuvant ET. Though numbers declined over time, daily adherence for palbociclib and ET remained relatively high at each cycle.

The trial is registered with ClinicalTrials.gov (NCT02513394; 07-31-2015) and EudraCT (2014-005181-30).

Adjuvant endocrine therapy (AET) reduces breast cancer recurrence, but side effects and distress impact adherence. We co-designed an Acceptance and Commitment Therapy (ACT) intervention to support medication decision-making and quality of life in women prescribed AET (ACTION). In a qualitative process evaluation nested in the pilot trial, we aimed to elicit participant experiences of receipt and therapists experience of delivery of ACTION to enhance our understanding of acceptability.

Remote semi-structured interviews were conducted with women with breast cancer who received ACTION (n = 20) and trial therapists (n = 3).

Interviews were guided by the Theoretical Framework of Acceptability (TFA). Rapid Assessment Procedure (RAP) sheets were completed after each interview to map responses onto TFA constructs, and sections of interviews were selectively transcribed. Individual RAP sheets were collated to identify key findings.

ACTION was generally liked, in particular, the group format (affective attitude). Participants and therapists felt ACTION was low effort, but therapists acknowledged the burden associated with trial procedures (burden). Participants generally felt able to engage with ACTION, and therapists felt they were able to deliver it (self-efficacy). The perceived effectiveness of ACTION on well-being was good, but was mixed for impact on treatment adherence (perceived effectiveness). Participants and therapists understood the aims of ACTION (coherence), and ACTION generally aligned with therapists' values (ethicality). Therapists questioned who would be most appropriate to deliver ACTION (opportunity costs).

ACTION was acceptable to women with breast cancer and trial therapists. Rapid qualitative analysis can facilitate efficient process evaluations in time- and resource-limited contexts.

In Sub-Saharan Africa (SSA), resource-stratified guidelines for breast cancer treatment are increasingly recommended, but treatment receipt and outcomes according to these guidelines are underreported. Here, we describe breast cancer treatment patterns by stage and curative-intent guideline-concordant treatment (GCT) receipt among Malawian women.

A prospective cohort of breast cancer patients were enrolled from December 2016 to October 2018 at Kamuzu Central Hospital with an assessment of demographics, stage, and treatment received, including neoadjuvant (NAC), adjuvant (AdC) and palliative chemotherapy and breast surgery. Curative-intent GCT was defined as having completed breast surgery and at least 4 cycles of chemotherapy. Overall survival (OS) was calculated using Kaplan Meier methods and odds ratios using logistic regression.

91 patients were included, of whom 13 (14%) presented as stage II, 54 (59%) as stage III, and 24 (26%) as stage IV. Curative treatment was recommended for 65 of 91 (71%) patients, of whom 47 (72%) were initiated on NAC, 14 (22%) on upfront breast surgery, and 4 (6%) received no treatment. Only 63% (41/65) of patients received curative-intent GCT as recommended with non-GCT associated with stage III (vs. stage II) disease (OR 0.10 CI (0.01-0.89)), HIV positivity ((OR 0.25 CI (0.06-0.99)) and hormone receptor (HR) negative/HER2 positive subtype ((OR 0.07 CI (0.01-0.49)). Curative-intent GCT was associated with improved OS (44.1 vs. 23.2 months; p = 0.00) compared to non-GCT.

While curative-intent GCT was associated with improved survival in this Malawian cohort, treatment completion rates were suboptimal. Resource-stratified guidelines must be paired with locally relevant, multilevel implementation strategies to target barriers to treatment completion.

Poor adherence to oral endocrine therapy (OET) is a significant problem among patients with hormone receptor-positive breast cancer as it results in higher risk of recurrence and mortality. Non-adherence to OET is prevalent among underserved patients, often attributable to socioeconomic factors and limited healthcare access. We evaluated OET adherence patterns over time using group-based trajectory modeling (GBTM) and identified predictors of suboptimal adherence trajectory among patients seen at Harris Health System, serving underserved patients in Houston, Texas.

A single-center, retrospective study was conducted from October 2019 through December 2020. OET adherence was measured using proportion of days covered (PDC). A logistic GBTM was conducted using 2-5 adherence groups considering the Bayesian information criteria, clinical relevance, and a 5% minimum membership requirement. Multinomial logistic regression was used to assess the predictors of non-adherence trajectories.

Among 496 patients, majority were Hispanic (62.50%) or African American (15.12%) and <65 years of age (82.66%). Four distinct adherence trajectories were identified: consistent high adherence (41.4%); constant PDC at ~0.6 (32.6%); rapid decline (14.6%); low adherence with gradual decline (11.5%). African Americans had higher likelihood of having low adherence with gradual decline [odds ratio (OR): 2.462 (confidence interval (CI): 1.1149-5.276), p=0.0205]. Patients with diabetes were more likely to have constant PDC at ~0.6 [OR: 1.714 (CI: 1.042-2.820), p=0.0338]. Longer time (4 or greater years) on therapy predicted low adherence with gradual decline [OR: 2.463 (CI: 1.266-4.793), p=0.008) and constant PDC at ~0.6 (OR: 1.966 (CI: 1.141-3.388), p=0.0149] trajectories.

The identified predictors, including comorbidities like diabetes, African American descent, and longer OET treatment are crucial considerations when developing patient-centered interventions to enhance OET adherence among underserved populations. These insights can guide the implementation of initiatives such as mobile health applications, community-based educational programs, and financial aid efforts.

The modern generation of trials evaluating the role of adjuvant radiation have turned to genomic profiling as a further risk stratification tool. The LUMINA trial by Whelan and colleagues, published in the New England Journal of Medicine , applied Ki67 testing to identify those with luminal A disease and evaluated locoregional outcomes with breast-conserving surgery and endocrine therapy alone. This article was reviewed at the Canadian Association of General Surgeons' "Evidence-Based Reviews in Surgery" webinar series. Here, we present the Evidence-Based Reviews in Surgery panel's methodologic review and clinical commentary. The LUMINA study demonstrated very low rates of local recurrence in low-risk patients with luminal A biologic subtype treated with breast-conserving surgery and endocrine therapy alone without radiation. Although the LUMINA study was rigorously designed and executed, there are significant pragmatic limitations to the implementation of the proposed approach using their protocol. We advocate that there is no "one-size-fits-all" approach to early estrogen receptor + breast cancer. The choice of treatment strategy should strongly consider patient goals and preferences, with the need for incorporation of quality of life and patient-reported endpoints into future studies evaluating this population to help guide these nuanced decisions.

Breast cancer survivors face a higher risk of subsequent primary cancers. This study investigated the patterns of subsequent cancer risk according to time since breast cancer diagnosis.

Using data from the Surveillance, Epidemiology, and End Results Program (2000-2018), we identified a cohort of 771,681 breast cancer survivors. Standard incidence ratios (SIR) were calculated by comparing the observed with the expected number of subsequent cancers over different follow-up periods since breast cancer diagnosis. Analyses were conducted for multiple cancer types, stratified by hormone receptor status, treatment of the first breast cancer, age, and race/ethnicity.

Survivors experienced a 16% increased risk of subsequent cancer with the SIR continuing to increase with longer follow-up (SIR = 1.04, 1.22, and 1.31 for 12-59, 60-119, and ≥120 months). This trend was driven primarily by a subsequent breast cancer, particularly among women <50 years of age, those with initial hormone receptor-negative cancer, and racial/ethnic minorities. The patterns of subsequent non-breast cancer risk varied by type. An early-onset and sustained increased risk was observed for subsequent leukemia, thyroid cancer, soft-tissue sarcoma, melanoma, pancreatic cancer, and uterine cancer. A delayed increased risk was observed for subsequent esophageal, ovarian, oral cavity/pharyngeal, and lung cancers, whereas for small intestine, stomach, kidney, and colorectal cancers, there was a decrease after an initial increased risk.

Patterns in subsequent cancer risk since breast cancer diagnosis differ by cancer type and characteristics of the first breast cancer.

These findings can inform etiology and tailored approaches to screening and prevention of subsequent cancers.

Several studies have illustrated value in early patient contact following oral anticancer medication (OAM) initiation, particularly within the first 14 days of therapy, as adverse effects may lead to early discontinuation or poor adherence. Health-system specialty pharmacies (HSSPs) are optimally positioned to adopt this best practice through formalized protocols designed to identify and mitigate medication-related issues.

To outline an HSSP-led early check-in protocol for patients taking OAMs and to describe the subsequent interventions conducted by the HSSP team and their acceptance rate.

HSSPs enacted a protocol in January 2021 requiring oncology pharmacists - to contact patients within 14 days of OAM initiation, aiming to optimize adverse effect management, offer supportive care, address adherence, and provide education. To evaluate the impact of the early check-in protocol, we conducted a retrospective, multicenter, observational study across CPS's health system clients from January 2022 to November 2023. HSSP pharmacists created 1698 interventions for 1184 patients from the early check-in. The cancer types most frequently associated with an intervention were breast (n = 431, 25.4%), gastrointestinal (n = 245, 14.4%), and prostate (n = 206, 12.1%). The most frequent intervention categories were adverse drug reactions (ADRs) (n = 1,548, 91.2%) and adherence (n = 55, 3.2%). Overall, 95.5% of pharmacist recommendations were accepted by patients and/or providers.

Implementing an early check-in protocol allows HSSP pharmacists to mitigate barriers to OAM adherence. This study emphasizes the importance of early check-in and illustrates the scope of the oncology pharmacist's role by evaluating critically meaningful interventions and quantifying pharmacist recommendations and acceptance rate.

The optimal approach for partial breast irradiation (PBI) is unknown. We investigated a novel de-intensified 3-fraction PBI regimen for photons, protons, and brachytherapy.

A multicenter nonrandomized controlled trial with the primary outcome of adverse cosmesis at 3 years versus before PBI. Eligibility criteria were age ≥50 years treated with breast-conserving surgery for node-negative estrogen receptor-positive (ER+) invasive breast cancer or any ductal carcinoma in situ (DCIS) measuring ≤2.5 cm. Photon and proton PBI were prescribed 21.9 Gy (relative biological effectiveness) and brachytherapy 21 Gy in 3 fractions. Radiation therapy technique and adjuvant endocrine therapy were selected at physician and patient discretion.

Between June 17, 2015, and July 13, 2017, 161 eligible patients were treated with photons (56), protons (49), or brachytherapy (56). Median patient age was 66.8 years. One hundred twenty-six (78.3%) had invasive breast cancer (all ER+) and 35 (21.7%) had DCIS (88.6% ER+). Fifty-four percent of patients with invasive breast cancer and 25.8% of patients with ER+ DCIS initiated and adhered to the prescribed endocrine therapy. The proportion of patients with adverse cosmesis (by trained nurse assessment) was 14.5% at baseline and 2.3% at 3 years (difference, -12.2%; 95% CI, -100% to -6.4%). Adverse cosmesis at the last follow-up, with a median follow-up of 5 years, was 5.7% by nurse assessment, 5.6% by panel assessment of digital photographs, and 5.2% by patient self-report. There were no observed clinically meaningful changes in other patient-reported outcomes, and just 2 grade 2 or higher adverse events, both grade 2, in the brachytherapy cohort. Five-year local recurrence-free survival and progression-free survival were 98.0% and 95.5%, respectively. There were no local recurrences among 60 patients with invasive breast cancer and Ki67 ≤13.25%.

Deintensified 3-day PBI provided favorable disease control, tolerability, and cosmetic outcomes, meeting the prespecified criteria for acceptability. This approach is an attractive option for patients with small node-negative ER+ breast cancer and DCIS.

Aromatase inhibitors (AIs) are a cornerstone of adjuvant systemic therapy for postmenopausal patients with hormone-receptor positive (HR+) breast cancer. Although AIs decrease cancer recurrence rates and improve survival rates, approximately 50 % of patients experience arthralgia-persistent pain related to worse patient outcomes and poor AI adherence. Current medical interventions for AI-associated arthralgia have limited efficacy and side effects that restrict their use among older patients.

The SKIP-Arthralgia trial will test the efficacy of Pain Coping Skills Training (PCST), a cognitive-behavioral therapy (CBT)-informed intervention, delivered via a web-based program called painTRAINER®. PCST and similar CBT-informed pain interventions are efficacious in non-cancer pain and commonly delivered via the Internet, although they have not been tested as a treatment for AI-associated arthralgia.

452 breast cancer survivors with AI-associated arthralgia will complete a baseline assessment before being randomized to either painTRAINER plus enhanced usual care (EUC; educational materials about AI therapy, arthralgia, and pain), or to EUC alone. Follow-up assessments will occur approximately 2 weeks after the 8- to 10-week intervention period (post-intervention) and at 3- and 6-months post-intervention. Primary outcomes are pain severity and interference at post-intervention. Secondary outcomes include emotional distress, AI adherence, and health-related quality of life.

This trial aims to fill a gap in evidence-based behavioral pain interventions for breast cancer survivors with AI-associated arthralgia by providing an effective, accessible intervention that could be implemented quickly, including in areas with limited PCST access. If successful, this study could enhance health outcomes for breast cancer survivors on AI therapy and improve adherence to this life-saving medication.

Medication nonadherence is common among patients with breast cancer (BC) and increases BC mortality and complications from comorbidities. There is growing interest in mobile health interventions such as smartphone applications (apps) to promote adherence.

Use of Medisafe, a medication reminder and tracking app, was tested over 12 weeks among patients on BC treatment and at least one oral medication. Study participants were instructed to generate adherence reports every 4 weeks through Medisafe and were deemed to have completed the intervention if >50% of reports were generated. The primary end point was feasibility of the intervention, defined as a completion rate of ≥75% of consented patients. Secondary end points included changes in self-reported nonadherence from baseline to 12 weeks and patient-reported outcomes including reasons for nonadherence and satisfaction with Medisafe. We conducted univariable and multivariable analyses to evaluate demographic and clinical factors associated with intervention completion.

Among 100 patients enrolled, 78 (78.0%) completed the intervention. Age, race, ethnicity, clinical stage, and type of medication were not associated with odds of intervention completion. Self-reported nonadherence rates did not improve from baseline to postintervention in the overall study population. However, among patients with self-reported nonadherence at baseline, 26.3% reported adherence postintervention; these patients frequently reported logistical barriers to adherence. Study participants reported high levels of satisfaction with Medisafe, noting that the app was highly functional and provided high-quality information.

Smartphone apps such as Medisafe are feasible and associated with high patient satisfaction. They may improve adherence in nonadherent patients and those who face logistical challenges interfering with medication-taking. Future trials of mobile health interventions should target patients at high risk for medication nonadherence.

Neighborhood socioeconomic deprivation (NSD) is associated with worse outcomes among patients with cancer, but little is known about NSD-related disparities in patient-reported outcomes (PRO) in clinical trials. We examined the relationship between PROs and NSD in symptom management trials among women with breast cancer.

We pooled data from three SWOG randomized trials to examine four outcomes: physical and functional wellbeing (PWB, FWB), average pain, and pain interference. NSD was measured using participants' zip code linked to the area deprivation index (ADI) score, categorized into tertiles. Multivariable linear regression adjusted for sociodemographic and clinical characteristics was used to analyze baseline PROs. Linear mixed models were used to examine if trajectory of PROs from baseline through 24 weeks varied by ADI.

We examined 761 participants, of whom 51% were from least deprived neighborhoods. Participants in the most deprived neighborhoods had worse average pain at baseline (β = .38, 95% CI = .03 to .72, p = .03) while participants in somewhat deprived areas also had worse FWB (β = -1.07, 95% CI = -1.95 to -.20, p = .02) and pain interference (β = 0.42, 95% CI = .09 to .75, p = .01) compared to those from least deprived areas. Hispanic ethnicity and having Medicaid/no insurance were associated with worse outcomes. After adjusting for baseline score, ADI was not associated with any outcome over time.

Breast cancer patients living in areas with NSD had worse FWB, joint pain, and pain interference at baseline. Clinical trial participants should be screened for community-level needs. Implementing interventions to address those needs could help mitigate disparities.

Injectable GnRH receptor agonists have been shown to improve cancer control when combined with radiotherapy (RT). Relugolix is an oral GnRH receptor antagonist that achieves rapid testosterone suppression. Non-adherence to oral medications due to poor social support or bothersome side effects may increase the risk of cancer recurrence. This prospective study sought to evaluate early testosterone suppression and relugolix drug adherence when combined with prostate stereotactic body radiation therapy (SBRT). Utilization of patient-reported outcomes (PROs) to assess oral medication adherence and guide intervention may improve the appropriate utilization of oral medications. This study focuses on the use of the Simplified Medication Adherence Questionnaire (SMAQ) as a tool to assess relugolix adherence.

Relugolix was initiated at least 2 months prior to questionnaire administration. Adherence was assessed using the SMAQ. Total testosterone levels were obtained at the time of SMAQ administration. Castration was defined as serum testosterone ≤ 50 ng/dL. Poor drug adherence was delineated as failure to reach castration or non-adherence per the SMAQ (any non-adherence answer, missed > 2 doses in last week or since last visit). To compare the demographic and clinical characteristics of patients who adhered to treatment versus who did not, t-test, Wilcoxon rank sum test, Chi-square test, and Fisher's exact test were used. A p-value < 0.05 determined statistical significance.

Between August 2021 and December 2023, 78 men were treated at Georgetown with relugolix and prostate SBRT per an institutional protocol. The median age was 72, and 41% of patients were non-white. Patients initiated relugolix at a median of 4 months prior to the SMAQ (2-19 months). 96% of patients achieved castration (≤ 50 ng/dL) at the time of the SMAQ. 96% of men reported always taking relugolix at the appropriate time. 1% discontinued medication due to bothersome side effects, 17% reported forgetting to take the medication, and 4% reported missing a dose during the weekend. 98% and 93% did not miss a dose more than 2 times in the last week and since the last visit, respectively. Overall patient-reported drug adherence was 75%. No patient demographic or clinical characteristic predicted non-adherence.

Relugolix allows for high rates of castration and drug adherence when combined with prostate SBRT. Monitoring drug adherence during treatment allows for prompt detection of non-adherence and timely intervention. Future studies should focus on how to optimally incorporate this questionnaire into patient management.

Adherence to adjuvant endocrine therapy in women with breast cancer is low. We conducted a 24-1 fractional factorial pilot optimization trial to test four intervention components supporting medication adherence [text messages, information leaflet, acceptance and commitment therapy (ACT), self-management website], in the preparation phase of the multiphase optimization strategy. Guided by the National Institute of Health Behavior Change Consortium fidelity framework, we investigated fidelity of design, training, delivery, receipt, and enactment of four intervention components. Women prescribed adjuvant endocrine therapy (n = 52) were randomized to one of eight experimental conditions comprised of combinations of the four intervention components (ISRCTN: 10487576). We assessed fidelity using self-report data (4 months post-randomization), trial data, ACT session observations, behavior change technique (BCT) coding, and interviews with participants (n = 20) and therapists (n = 6). Design: Each intervention component targeted unique behavior change techniques with some overlap. Training: All 10 therapists passed the competency assessment. Delivery: All leaflets (27/27) and website (26/26) details were sent, and ACT procedural fidelity was high (85.1%-94.3%). A median of 32.5/41 (range 11-41) text messages were delivered, but a system error prevented some messages being sent to 22 of 28 participants. Receipt: Most participants [63.0% (ACT, leaflet) to 71.4% (text messages)] read all or at least some of the intervention components they were randomized to receive. Enactment was reported most positively for ACT. All intervention components demonstrated adequate fidelity. We have provided an exemplar for assessing fidelity using the National Institute of Health Behavior Change Consortium framework in the preparation phase of multiphase optimization strategy.

Adherence to adjuvant endocrine therapy (AET) in women with breast cancer is poor. Multicomponent intervention packages are needed to address adherence barriers. Optimizing these packages prior to definitive evaluation can increase their effectiveness, affordability, scalability, and efficiency.

To pilot procedures for an optimization-randomized controlled trial (O-RCT) of the 'Refining and Optimizing Strategies to support Endocrine Therapy Adherence' (ROSETA) intervention.

This was a multisite individually randomized external pilot trial using a 24-1 fractional factorial design (ISRCTN10487576). Breast cancer survivors prescribed AET were recruited from 5 hospitals and randomized to one of 8 conditions, each comprising a combination of 4 intervention components set to "on" or "off" (SMS messages, information leaflet, guided self-help, and self-management website). We set criteria to inform the decision to progress to an O-RCT for consent rate, component adherence, and availability of outcome measures, with predefined cutoffs for "green" (proceed), "amber" (minor changes), and "red" (major changes).

Among 141 eligible patients, 54 (38.3%) consented (green range). At least 50.0% of participants adhered to the minimum threshold set for each intervention component (green range). Data for one of the 3 medication adherence measures were available (amber range). Most (86.8%) participants were satisfied with their trial experience. Exploratory analysis indicated some evidence of a negative main effect of the information leaflet on medication adherence (adjusted mean difference = 0.088, 95% CI, 0.018, 0.158).

Progression to a fully powered O-RCT of the ROSETA intervention package is feasible, but review of medication adherence measures is required.

Despite significant advances in breast cancer control and survival with endocrine therapies (ETs), treatment utilization and outcomes in developing countries have not been adequately explored. This review evaluated ET adherence, potential benefits, and harms in populations across developing countries.

A literature search was conducted through August 2023 in five databases: PubMed, Cochrane Library, Web of Science, Global Health, and WHO Global Index Medicus. Retrieved records were screened to identify observational research presenting at least one outcome in women with nonmetastatic breast cancer in developing countries who received ET (tamoxifen or aromatase inhibitors). A random effects model was used to compute the rates of adherence, discontinuation, adverse events (AEs), disease progression, and death.

A total of 104 studies met the inclusion criteria. Risk of bias was low in most studies, and a large portion of the patients involved Asians. The overall heterogeneity between studies was partially attributed to variations in study design or outcome measurement method. Results showed a pooled adherence rate of 75% (95% confidence interval [CI], 67%-81%) and a discontinuation rate of 16% (95% CI, 10%-25%). Treatment side effects and young age consistently emerged as significant predictors of nonadherence. A wide range of AEs was identified in our analysis. The estimated average rates of cancer recurrence and mortality at 5-years were 16% and 8%, respectively.

The findings of this study underscore suboptimal ET use in developing countries and provide comprehensive insights into treatment experiences in the real-world setting. Targeted strategies are warranted to enhance adherence and subsequently optimize treatment benefits.

Aromatase inhibitor is associated with a high incidence of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS) in postmenopausal women with hormone-sensitive breast cancer.

This scoping review aims to identify available information regarding the frameworks, models, or strategies of adapted physical activity (APA) programs implemented for the prevention and management of AIMSS.

Search was realized by two independent reviewers in six databases following PRISMA-ScR guidelines. Data of included articles were extracted, and risk of bias analyzed.

Finally, 14 were included. No study has examined APA in the prevention of AIMSS. There is no solid evidence supporting the impact of APA on the management of AIMSS. However, evidence suggests that an APA program can reduce the worst joint pain and improve the quality of life.

Future research will enlighten clinical practices with the development of personalized APA programs in hormone-sensitive breast cancer.

Remote symptom monitoring (RSM) using electronic patient-reported outcomes (ePROS) connects patients and health care teams between appointments. Patient-perceived benefits and drawbacks of RSM are well-known, but health care team members' perceptions are less clear.

Health care team members from the University of Alabama at Birmingham and the University of South Alabama Health Mitchell Cancer Institute participated in semi-structured qualitative interviews to explore their experiences and perspectives on RSM benefits and limitations. Interviews were audio-recorded, transcribed, and analyzed inductively using NVivo software to identify recurring themes and exemplary quotes.

Thirty oncology health care team members, including physicians (n = 9), nurse practitioners (n = 2), nurses (n = 8), nonclinical navigators (n = 7), and administrators (n = 4), were interviewed. Findings were organized into five major themes: three benefits (Proactive, Improved Patient-Health Care Team Relationship, and Patient Engagement and Symptom Reporting) and two limitations (Health Care Team-Perceived Limited Patient Buy-In or Awareness and Workload and Workflow Issues). Health care team members perceived that RSM improved their ability to support patients and the quality of care delivered to patients by promoting proactive management, strengthening the patient-health care team relationship, and engaging patients in symptom reporting. Despite positive perceptions, health care team members also voiced drawbacks of RSM related to the lack of patient buy-in or awareness and increased workload and disrupted workflow.

Although health care team members recognized the benefits of RSM as a standard of care, future work is necessary to address identified limitations to support wide-scale implementation of RSM in oncology practices.

Oral adjuvant endocrine therapy (AET) reduces the risk of cancer recurrence and death for women with hormone receptor-positive (HR+) breast cancer. Because of adverse symptoms and socioecologic barriers, AET adherence rates are low. We conducted post hoc analyses of a randomized trial of a remote symptom and adherence monitoring app to evaluate characteristics associated with higher app use, satisfaction, and how app use was associated with AET adherence.

Patients prescribed AET were randomly assigned to receive one of three intervention conditions: app, app + feedback, or enhanced usual care. Baseline and 6-month follow-up surveys, app use, and pillbox-monitored AET adherence data for app and app + feedback participants were used. Logistic regression evaluated the association between sociodemographic/clinical characteristics and app utilization and satisfaction, and how app use was associated with AET adherence (>80%).

Overall, 163 women with early-stage HR+ breast cancer were included; 35.0% had high app use (≥75% of weeks enrolled). No sociodemographic characteristics were associated with app use. Satisfaction with the app was higher among those who were younger (88.9% for age 31-49 years v 54.9% for age 65+ years, P < .001), identified as White (76.8% v 60.1% for Black, P = .045), had lower health literacy (85.4% v 68.2% with higher health literacy, P = .017), or were nonurban residents (85.7% v 68.6% for urban, P = .021). Most participants (90.3%) with high app use were AET-adherent compared with 66.8% for those with lower app use (P < .001).

Use of a remote monitoring app was similar across sociodemographic characteristics, and more frequent app use was associated with a higher likelihood of 6-month AET adherence. Encouraging women to monitor medication adherence and communicate adverse symptoms could improve AET adherence.

To examine utilization of a dedicated menopause symptoms after cancer clinic (MSAC) and to determine whether women referred to the MSAC for management of severe hot flush symptoms are more likely to adhere to endocrine therapy compare to those with severe symptoms not referred to MSAC.

Breast cancer patients prescribed endocrine therapy with a diagnosis of estrogen-receptor positive breast cancer between January 2003 and December 2011 were identified from the Royal Perth Hospital Breast Unit database. Details of breast cancer pathology, endocrine therapy, endocrine therapy related side effects, referral to MSAC and patient reported adherence to endocrine therapy for up to 4 years were ascertained from the database and medical records systems. For those with severe vasomotor symptoms, total duration of endocrine therapy was compared between women referred to MSAC and those who were not referred to MSAC.

About 1275 women were identified from the database, with the cohort followed up until Dec 2016. Of these women, 120 (9.4%) were referred to MSAC and 1155 (90.1%) received usual care. In total, 147 reported severe vasomotor symptoms of whom almost half (71) were referred to MSAC. Women with severe vasomotor symptoms managed by MSAC were less likely to discontinue endocrine therapy (15.5%) compared with those managed with usual care (26.3%). However, this difference was not statistically significant (chi-square test statistic = 2.584, 1df, P = .1).

Management of severe vasomotor symptoms at a dedicated menopause clinic may increase adherence to endocrine therapy for breast cancer.

This retrospective cohort study evaluated whether linked electronic health record (EHR) pharmacy data were adequately complete and timely to detect primary nonadherence to breast cancer adjuvant endocrine therapy (AET).

Linked EHR pharmacy data were extracted from the EHR for patients with stage 0 to III breast cancer who had their first prescription order for AET between 2016 and 2021. Patients with the first dispense event within 90 days of the prescription were classified as having sufficient or insufficient data available for early detection of primary adherence.

A total of 1,446 eligible patients had a first AET prescription order between 2016 and 2021; these orders were routed to 871 unique pharmacies, of which 856 (98.2%) were contracted with the linked EHR pharmacy database and 15 (1.8%) were not contracted. Among the 1,428 patients with a first prescription sent to a contract pharmacy, 164 (13%) had incomplete linked EHR pharmacy data refresh events to assess primary adherence. Among the 1,244 patients with at least 1 refresh event after their first prescription, 82% occurred within 90 days and were sufficiently timely for early detection of primary adherence. Overall, 32% of patients would benefit from an intervention to verify or improve primary adherence to AET.

Although linked EHR pharmacy data have adequate completeness of contract pharmacy data, local configurations of data refresh events tailored to medication reconciliation workflows are incomplete (13%) and insufficiently timely (32%) to fully support clinical decision support (CDS) for early detection of primary medication nonadherence. Prospective CDS interventions using linked EHR pharmacy data are possible with enhancements to the frequency and timeliness of refresh events.

Numerous clinical trials have compared the efficacy of endocrine therapy in post-menopausal breast cancer patients. This study aims to explore whether there is a difference in recurrence rates between this population using tamoxifen and aromatase inhibitors (AIs) by analyzing real-world data.

This retrospective cohort study utilized the National Health Insurance (NHI) claims data and the Taiwan Cancer Registry (TCR). We identified 6,050 patients aged over 55 diagnosed with ER-positive, HER2-negative early breast cancer between 2012 and 2016 (4,451 on AIs alone and 1,599 on tamoxifen alone). Recurrence in both groups was assessed until the end of 2020. Hazards were measured based on age of diagnosis, cancer stage, adjuvant chemotherapy, radiation therapy, type of endocrine therapy used, and adherence. Recurrence‑free survival between the AIs and tamoxifen groups was evaluated using the Kaplan-Meier model.

The average age was 65.1 years, with a median follow-up time of 5.7 years and a median duration of endocrine therapy of 4.5 years. The recurrence rate was 2.2%. Using tamoxifen as endocrine therapy reduces the risk of recurrence compared to AIs (adjusted HR: 0.32, p < 0.0001). There was no statistical difference between the two drugs in stage 1 breast cancer. However, in stage 2, the risk of breast cancer recurrence decreased to 0.15 times with the use of tamoxifen compared to AIs (p = 0.0002). Stage 2 cancer, histological grade 3, and non-adherence increased recurrence risk in post-menopausal breast cancer patients.

Based on real-world data analysis, in ER-positive, HER2-negative post-menopausal women with early breast cancer in Taiwan, the use of tamoxifen compared to AIs is associated with a lower risk of recurrence. Improved adherence to medication can break the cycle of recurrence and improve health outcomes.

Adjuvant endocrine treatment (AET) is crucial in early oestrogen receptor (ER)-positive breast cancer (BC), providing reduced recurrence rate and increased overall survival. The aim of this study was to estimate AET adherence rates by age at diagnosis and region in Sweden.

In total, 10,422 women diagnosed with ER-positive BC in 2008-2010 were identified in the Swedish National BC Registry. Information on prescriptions and dispensation of AET was gathered through record linkage to the Swedish Prescription Registry. 1, 3- and 5-year medication possession ratios (MPRs) were calculated. Good adherence was set as MPR ≥ 80%.

The 1-, 3- and 5-year AET age-adjusted adherence rates were 94.4, 87.6 and 81.6%, respectively. The 1-, 3- and 5- year adherence rate was significantly highest in the South region (96.2, 90.5 and 86.2%). Regions with an oncologic clinic had higher adherence rate than regions without, 82.8% versus 75.5% at 5-year FU. Women at age 40-64 years (95.6, 89.9 and 84.1%) and 65-74 years at diagnosis (95.7, 89.5 and 84.6%) had significantly higher adherence rate than women ≥ 75 years at diagnosis (89.1, 79.2 and 68.3%).

Despite guidelines being national, there were significant differences in adherence between regions in Sweden. As the largest differences were between age groups invited and not invited to mammography screening intervention should focus on women < 40 and ≥ 75 years at diagnosis. Further studies are needed to find strategies to increase overall adherence to AET in early BC.

This review aims to synthesize available literature on uterine-conserving treatment options for atypical endometrial hyperplasia and grade 1 endometrial carcinoma while highlighting remaining unanswered questions.

The need for uterine-conserving treatment options for atypical endometrial hyperplasia and grade 1 endometrial carcinoma is growing with the increasing number of cases in younger patients or those who cannot undergo surgery. We reviewed the oncological and reproductive outcomes associated with endocrine therapies used for atypical endometrial hyperplasia and grade 1 endometrial carcinoma. The rising prevalence of delayed childbearing, obesity, and diabetes in reproductive-age individuals and of medical comorbidities associated with high surgical risk continues to amplify the demand for uterine-conserving therapies. Appropriate patient selection for such therapies is imperative to maximize likelihood of treatment response. The ideal candidates are patients with atypical endometrial hyperplasia or early-stage, low-grade endometrial cancer with no evidence of myometrial invasion or extrauterine disease. The most accepted conservative therapeutic approach is hormonal therapy with close surveillance, with or without eventual hysterectomy following childbearing or failure of treatment. Further prospective and randomized trials are needed to address optimal patient and treatment selection, as well as the use of molecular profiling for treatment individualization and prognostication.

We sought to understand why some women with early-stage breast cancer decide to forgo or discontinue endocrine therapy (ET), and to identify factors that might lead to greater acceptance of, and long-term adherence to, this treatment.

We conducted in-depth interviews with N = 53 stage I-III HR+ women who were either non-initiators of ET, initiators who discontinued or initiators who continued with variable daily patterns of adherence. An inductive content analysis was performed to explore the decision-making process of women prescribed ET.

Qualitative analyses revealed 55 themes that drove complex decision making. The initiators generally trusted their physicians and did little research before starting the medication. Non-initiators were more suspicious of the medical system, believing that ET presented more risks than benefits. Most discontinuers stopped ET because of side effects. Both non-initiators and discontinuers indicated that push-back from their physicians could have changed their decision. Stories and social support were important in decision making.

Although ET can significantly reduce the risk of breast cancer recurrence, substantial barriers prevent many women from initiating or continuing it.

Physicians have powerful influence over patients' decisions to initiate ET and can be important levers for motivating patients to persist.

Adjuvant endocrine therapy (AET) reduces mortality in early-stage breast cancer, but adherence is low. We developed a multicomponent intervention to support AET adherence comprising: text messages, information leaflet, acceptance and commitment therapy (ACT), and side-effect website. Guided by the multiphase optimization strategy, the intervention components were tested in the ROSETA pilot optimization trial. Our mixed-methods process evaluation investigated component acceptability. The pilot optimization trial used a 24-1 fractional factorial design. Fifty-two women prescribed AET were randomized to one of eight experimental conditions, containing unique component combinations. An acceptability questionnaire was administered 4 months post-randomization, and semi-structured interviews with 20 participants further explored acceptability. Assessments were guided by four constructs of the theoretical framework of acceptability: affective attitude, burden, perceived effectiveness, and coherence. Quantitative and qualitative findings were triangulated to identify agreements/disagreements. There were high overall acceptability scores (median = 14-15/20, range = 11-20). There was agreement between the qualitative and quantitative findings when triangulated. Most participants "liked" or "strongly liked" all components and reported they required low effort to engage in. Between 50% (leaflet) and 65% (SMS) "agreed" or "strongly agreed," it was clear how each component would help adherence. Perceived effectiveness was mixed, with 35.0% (text messages) to 55.6% (ACT) of participants "agreeing" or "strongly agreeing" that each component would improve their adherence. Interview data provided suggestions for improvements. The four components were acceptable to women with breast cancer and will be refined. Mixed-methods and triangulation were useful methodological approaches and could be applied in other optimization trial process evaluations.