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

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

World J Gastrointest Oncol. 2020 Feb 15;12(2):205-218. doi: 10.4251/wjgo.v12.i2.205.

Authors

Karen Kaiser¹, Madison Lyleroehr², Sara Shaunfield², Leilani Lacson², Maria Corona², Sheetal Kircher³, Malin Nittve⁴, David Cella²

Affiliations

¹ Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, United States. k-kaiser@northwestern.edu.
² Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, United States.
³ Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, United States.
⁴ Project and Regulatory Affairs, PledPharma AB, Stockholm 114 46, Sweden.

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