Observational Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Feb 15, 2020; 12(2): 205-218
Published online Feb 15, 2020. doi: 10.4251/wjgo.v12.i2.205
Neuropathy experienced by colorectal cancer patients receiving oxaliplatin: A qualitative study to validate the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale
Karen Kaiser, Madison Lyleroehr, Sara Shaunfield, Leilani Lacson, Maria Corona, Sheetal Kircher, Malin Nittve, David Cella
Karen Kaiser, Madison Lyleroehr, Sara Shaunfield, Leilani Lacson, Maria Corona, David Cella, Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, United States
Sheetal Kircher, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, United States
Malin Nittve, Project and Regulatory Affairs, PledPharma AB, Stockholm 114 46, Sweden
Author contributions: Kaiser K, Shaunfield S and Cella D contributed to study conception and design; Kaiser K, Shaunfield S, Lyleroehr M, Lacson L, Kircher S and Corona M contributed to data acquisition, data analysis and data interpretation; Kaiser K contributed to writing of the article; Kaiser K, Lyleroehr M, Shaunfield S, Lacson L, Corona M, Kircher S, Nittve M and Cella D contributed to editing, reviewing, and final approval of the manuscript.
Institutional review board statement: ‎This study was reviewed and approved by the Ethics Committee of Northwestern University.
Informed consent statement: ‎ The patients provided written consent before participation in the study.
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
STROBE statement: ‎ The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Karen Kaiser, PhD, Associate Professor, Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 625 N Michigan Ave, Suite 2700, Chicago, IL 60611, United States. k-kaiser@northwestern.edu
Received: October 7, 2019
Peer-review started: October 7, 2019
First decision: October 18, 2019
Revised: October 29, 2019
Accepted: January 6, 2020
Article in press: January 6, 2020
Published online: February 15, 2020
Processing time: 130 Days and 20 Hours
Abstract
BACKGROUND

Although oxaliplatin is widely established as a standard treatment in colorectal cancer (CRC), oxaliplatin-induced neuropathy has emerged as a prominent dose-limiting side effect associated with quality of life decrements. Ongoing monitoring and management of neuropathy is important for CRC patient quality of life and adherence to treatment. Therefore, a validated self-reported measure of neuropathy would aid in the management and assessment of oxaliplatin-induced neuropathy in clinical practice and research. We sought to evaluate the content validity of the 13-item Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity subscale (FACT/GOG-Ntx) for CRC patients receiving oxaliplatin.

AIM

To understand the neuropathy experiences of CRC patients and assess content validity of the FACT/GOG-Ntx.

METHODS

Semi-structured concept elicitation and cognitive debriefing interviews were conducted with 31 CRC patients experiencing peripheral neuropathy from current or previous oxaliplatin treatment. Interview data were analyzed using a constant comparative approach, and data were mapped to the FACT/GOG-Ntx to assess content validity.

RESULTS

Mean age of the sample was 54 (range 34-82). The sample was primarily Caucasian (84%) and consisted of nearly equal numbers of men and women. Participants described 28 unique neuropathy symptoms; hand tingling (experienced by 87% of respondents); feet tingling (81%); hand numbness (68%); and feet numbness (84%) were most frequently mentioned. Neuropathy symptoms occurring on the feet were most often identified as most bothersome by participants. Eleven of the 13 FACT/GOG-Ntx items exhibited moderate to strong evidence of content validity. Two items related to trouble hearing and ringing in the ears had weak support; however, these items represent severe neuropathy and could be useful for a patient reported outcome measure.

CONCLUSION

The FACT/GOG-Ntx represents the key neuropathy experiences of CRC patients treated with oxaliplatin.

Keywords: Neuropathy; Colorectal cancer; Patient reported outcomes; Quality of life

Core tip: Colorectal cancer patients report significant impairment in dexterity, mobility, and balance due to neuropathy. Because prevention and treatment options for oxaliplatin-induced neuropathy are limited ongoing monitoring and management of neuropathy is important for patient quality of life and treatment adherence. A validated self-reported measure of neuropathy would aid in the management and assessment of neuropathy. This study examined the content validity of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale for colorectal patients with oxaliplatin-induced neuropathy; the measure was found to have content validity for this population.