mHealth App for Colorectal Cancer

No longer recruiting at 1 trial location
SA
Overseen BySarah A Kelleher, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called mCOPE, designed to help young and middle-aged adults with colorectal cancer manage symptoms like pain, fatigue, and stress. Participants will be randomly assigned to either use this app or receive standard care to determine if the app improves quality of life and symptom management. The app provides personalized coping strategies and real-time feedback, with sessions available via video calls at convenient times. Individuals diagnosed with colorectal cancer in the last three years who experience pain, fatigue, and distress may be well-suited for this study. As an unphased trial, this study offers participants the chance to explore innovative symptom management tools that could enhance their quality of life.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on teaching coping skills rather than changing your medication.

What prior data suggests that this mHealth protocol is safe for young and middle-aged colorectal cancer patients?

Research shows that mCOPE, a mobile health app designed to help manage symptoms like pain, fatigue, and stress in colorectal cancer patients, is generally safe to use. The app teaches coping skills using tools such as relaxation techniques and activity balancing. Previous studies have found that similar mobile health tools are well-received, with most users not experiencing serious side effects. Designed to fit into daily life without causing extra stress, the app helps ensure user comfort and safety. While specific safety data for mCOPE is still being collected, the use of familiar and gentle methods like changing thought patterns suggests it should be safe for most participants.12345

Why are researchers excited about this trial?

Researchers are excited about the mHealth Coping Skills Training for Symptom Management (mCOPE) because it offers a unique, digital approach to managing symptoms of colorectal cancer, which traditionally relies on medication, surgery, and chemotherapy. mCOPE is different because it leverages a mobile health app to provide coping skills training specifically tailored to manage multiple symptoms like pain, fatigue, and psychological distress. This method also addresses the unique challenges faced by young and middle-aged patients, such as balancing family and career responsibilities, potentially leading to a significant improvement in their overall quality of life. Through the accessibility and personalization of a mobile app, mCOPE has the potential to provide continuous, on-demand support that isn't typically available through standard care options.

What evidence suggests that the mCOPE protocol is effective for managing symptoms in young and middle-aged colorectal cancer patients?

Research shows that the mCOPE program, a treatment option in this trial, may help young and middle-aged colorectal cancer patients manage their symptoms more effectively. Studies suggest that mCOPE can lessen pain, tiredness, and emotional stress by teaching coping skills tailored to participants' specific needs and life challenges. The program uses a mobile app to track daily symptoms and provide immediate feedback, which can be helpful. This method aims to improve participants' quality of life by addressing their unique age-related challenges.12346

Who Is on the Research Team?

SA

Sarah A Kelleher, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for young and middle-aged adults with colorectal cancer who have experienced pain, fatigue, or psychological distress. They must have been diagnosed within the last three years and be able to speak and read English. Those with severe psychiatric conditions, recent coping skills training, inability to converse in English, or cognitive impairments like dementia cannot participate.

Inclusion Criteria

I experience significant pain, fatigue, or distress.
I was diagnosed with colorectal cancer in the last 3 years.
My cancer is between stage I and IV.
See 1 more

Exclusion Criteria

Cognitive impairment (e.g., dementia)
I do not have a severe psychiatric condition or suicidal thoughts.
Inability to converse in English
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mCOPE intervention via videoconferencing and mobile app to manage symptoms such as pain, fatigue, and psychological distress

10 weeks
5 videoconferencing sessions

Follow-up

Participants are monitored for changes in symptoms and quality of life post-intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • mHealth Coping Skills Training for Symptom Management (mCOPE)
Trial Overview The mCOPE intervention is being tested against standard care for its effectiveness in managing symptoms of pain, fatigue, and distress among colorectal cancer patients. It involves coping skills training delivered via videoconferencing and a mobile app that tracks symptoms and provides feedback.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: mHealth Coping Skills Training for Symptom Management (mCOPE)Experimental Treatment1 Intervention
Group II: Standard CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Citations

mHealth Coping Skills Training for Symptom Management ...We utilize a randomized controlled trial to test the extent to which mCOPE reduces pain, fatigue and distress (multiple primary outcomes) and improves quality ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37077935/
mHealth Coping Skills Training for Symptom Management ...Conclusions: mCOPE is innovative and potentially impactful for CRC patients in early to mid-adulthood. Hypothesis confirmation would demonstrate ...
Study Details | NCT04763174 | An mHealth Symptom ...mHealth technology, including a mobile app, will be used to capture daily symptom and coping skills use data, allowing the study team to provide personalized ...
D11 - Symptoms in a Sample of Colorectal Cancer Patients ...We developed a CBT-based mHealth coping skills training program (mCOPE) to reduce pain, fatigue and distress for younger CRC patients. The current analysis aims ...
mCOPE - Greenlight Health Data Solutions, Inc ...mCOPE is an innovative mobile health coping skills training protocol that is adapted to meet the multiple symptom needs and stage-of-life challenges faced by ...
An mHealth Symptom Management Intervention for Colorectal ...mHealth technology, including a mobile app, will be used to capture daily symptom and coping skills use data, allowing the study team to provide personalized ...
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