Mobile Mindfulness Meditation for Cancer-Related Anxiety and Neuropathy: Protocol for a Randomized Controlled Trial (Preprint)

A randomized waitlist controlled trial is described that will test the Mindfulness Coach mobile app for cancer survivors who have finished primary treatment and experience anxiety or cancer-related neuropathy. The trial aims to enroll 400 participants (200 for each condition) and collect data at baseline, 8 weeks, and 16 weeks. Outcomes are expected in early 2024. The study will also assess pain, fatigue, trauma, sleep, and satisfaction with the app.

Study at a glance

Abstract

BACKGROUND Anxiety- and cancer-related neuropathy are two persistent effects related to treatment for cancer. Mindfulness meditation has been used with substantial impact as a nonpharmacologic intervention to mitigate side and late effects of treatment. Mobile apps are ubiquitous for most of the general population, yet have a particular relevance for cancer survivors, given that physical and geographic limitations can be present. OBJECTIVE This study aims to describe an ongoing trial of the Mindfulness Coach mobile app for cancer survivors. METHODS In this randomized waitlist controlled trial, cancer survivors experiencing anxiety- or cancer-related neuropathy (200 for neuropathy and 200 for anxiety) and who had finished primary cancer treatment were invited to participate. Data were collected at 3 time points regardless of randomization condition: baseline, 8 weeks, and 16 weeks. Both face-to-face and web-based recruitment strategies were used. The trial was opened for 2 separate primary outcomes (anxiety- or cancer-related neuropathy). The goal was not to compare these groups but to compare treatment and waitlist groups for each condition. In addition to evaluating the impact of mobile mindfulness on reported anxiety- or cancer-related neuropathy, other pain, fatigue, trauma, sleep, and satisfaction with the Mindfulness Coach app will also be assessed. RESULTS Outcomes of the study are expected in early 2024. CONCLUSIONS Mindfulness meditation has become widely practiced, and the use of mobile technology has become ubiquitous. Finding ways to deliver mindfulness meditation to people who have been treated for cancer allows for the intervention to be accessible to a larger number of survivors. The results of this intervention could have implications for further understanding the impact of mindfulness meditation on 2 persistent side and late effects of treatment of cancer, namely anxiety- and cancer-related neuropathy. CLINICALTRIAL ClinicalTrials.gov NCT03581357; https://ClinicalTrials.gov/study/NCT03581357 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/47745