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

Ariel Siritorn Orasud, Mai Uchiyama, Ian Pagano, Erin O Bantum

JMIR Research Protocols February 12, 2024 DOI: 10.2196/47745 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized waitlist-controlled trial Peer reviewed
Sample size 400
Population Cancer survivors who finished primary cancer treatment and experience anxiety or cancer-related neuropathy
Intervention Mindfulness Coach mobile app
Duration 16-week follow-up
Topics Anxiety Meditation
Keywords Rct Cancer survivorship Clinical trials Coaching Mhealth Mental health Mindfulness meditation Mobile health Neuropathy Oncology Quality of life Randomized Well-being
Citations 3
Registration NCT03581357
Key findings The trial aims to evaluate whether the Mindfulness Coach mobile app reduces anxiety and cancer-related neuropathy in cancer survivors, with results expected in early 2024.

Abstract

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. This study aims to describe an ongoing trial of the Mindfulness Coach mobile app for cancer survivors. 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. Outcomes of the study are expected in early 2024. 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. ClinicalTrials.gov NCT03581357; https://ClinicalTrials.gov/study/NCT03581357. DERR1-10.2196/47745.

Comparable studies

Other randomized controlled trials on anxiety, most cited first.

Study Year Design Participants
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety 2016 Randomized controlled trial n = 51
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Patients with cancer-related anxiety and depression 2016 Double-blind, placebo-controlled, crossover trial n = 29
Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance Hallucinogen-naïve adults reporting regular participation in religious or spiritual... 2006 Double-blind study n = 36
Pilot Study of Psilocybin Treatment for Anxiety in Patients With Advanced-Stage Cancer Adults with advanced-stage cancer and anxiety 2010 Double-blind, placebo-controlled study n = 12

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