Completed

An mHealth Symptom Management Intervention for Colorectal Cancer Patients

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What is being tested

mHealth Coping Skills Training for Symptom Management (mCOPE)

Behavioral
Who is being recruted

Colonic Diseases+13

+ Digestive System Diseases

+ Digestive System Neoplasms

From 18 to 50 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2021
See protocol details

Summary

Principal SponsorDuke University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 15, 2021

Actual date on which the first participant was enrolled.

There is a high level of evidence that suggests cognitive and behavioral factors play an important role in colorectal cancer patients' abilities to cope with pain, fatigue and distress. Patients with multiple persistent symptoms may be particularly likely to have low confidence in their ability to control their symptoms (i.e., self-efficacy for symptom management). Cognitive behavioral coping skills protocols can enhance patients' abilities to cope with their symptoms in the context of age-related challenges; to date, these protocols have been tested in older patients and neither intervention content nor delivery modality meet the needs of younger patients. Intervention protocols aimed at young and middle-aged patients dealing with age-related stressors and high time demands must be adapted to meet the needs and challenges (e.g., coping skills practice strategies within the context of competing demands, communication with others about symptoms and limitations, relaxation for managing stoma-related pain, activity pacing to manage fatigue due to cancer and the demands of multiple life roles; cognitive restructuring negative thoughts surrounding managing time off work for treatment while maintaining health insurance and arranging childcare) of younger adults with cancer and delivered in a format (e.g., videoconferencing, adjunctive mobile app) that is acceptable and does not incur further demands. The investigators propose to use a randomized controlled trial (RCT) to test an innovative mHealth Coping Skills Training for Symptom Management (mCOPE) intervention designed to target pain, fatigue, psychological distress, and quality of life with unique content adapted for young and middle-aged colorectal cancer patients. mCOPE will be delivered with convenient mHealth modalities (videoconferencing, mobile app supported). Young and middle-aged adults with colorectal cancer that endorse multiple symptoms will be randomized to: 1) mCOPE or 2) standard care. mCOPE includes 5 videoconferencing sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing, cognitive restructuring) relevant to managing pain, fatigue and distress, and improving quality of life in the context of the unique challenges facing younger patients. mCOPE uses mHealth technology, including a mobile app, to capture daily symptom and coping skills use data and provide personalized support and feedback to patients. The central hypothesis is that mCOPE will result in decreased pain, fatigue and distress, and increased quality of life. Specific study aims are: Aim 1: Test the efficacy of mCOPE for improving symptoms and quality of life. Aim 2: Examine improved self-efficacy for symptom management as a mediator of symptom severity.

Official TitleAn mHealth Symptom Management Intervention for Colorectal Cancer Patients
NCT04763174
Principal SponsorDuke University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

167 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsFatigueGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteNeurologic ManifestationsPainRectal DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsColorectal Neoplasms

Criteria

4 inclusion criteria required to participate
Diagnosis of colorectal cancer within the past three years

Stages I-IV

Reported pain, fatigue and psychological distress - minimum two of three symptoms reported at 3 or greater on 0-10 scale

Able to speak and read English

4 exclusion criteria prevent from participating
Cognitive impairment (e.g., dementia)

Presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent)

Participation in a coping skills training protocol in the past 6 months

Inability to converse in English

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
mHealth Coping Skills Training for Symptom Management (mCOPE) protocol tests the efficacy of a theory-based symptom management intervention designed to target multiple interrelated symptoms (pain, fatigue, psychological distress) with content uniquely relevant for young and middle-aged colorectal cancer patients. Addressing the co-morbid consequences of cancer while providing support in the context of age-related challenges (e.g., caring for children and parents, career) has the potential to significantly improve overall quality of life in young and middle-aged patients with cancer.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Duke Regional Hospital

Durham, United StatesOpen Duke Regional Hospital in Google Maps
Suspended

Duke Cancer Institute

Durham, United States
Completed2 Study Centers