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mHealth App for Colorectal Cancer

N/A

Waitlist Available

Led By Sarah A Kelleher, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Stages I-IV

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-intervention (up to 10 weeks post-intervention), 3-month, and 6-month: approximately 20 minutes each time.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether an app can help young and middle-aged colorectal cancer patients with pain, fatigue, and distress. The app would teach patients coping skills and provide personalized real-time feedback.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since mCOPE focuses on symptom management through coping skills rather than medication or medical procedures, it may not have typical side effects. However, participants might experience emotional discomfort while discussing their experiences during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience significant pain, fatigue, or distress.

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My cancer is between stage I and IV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a severe psychiatric condition or suicidal thoughts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intervention (up to 10 weeks post-intervention), 3-month, and 6-month: approximately 20 minutes each time.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-intervention (up to 10 weeks post-intervention), 3-month, and 6-month: approximately 20 minutes each time.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (up to 10 weeks post-intervention), 3-month, and 6-month: approximately 20 minutes each time. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fatigue

Change in pain severity

Change in psychological distress

Secondary study objectives

Change in Self-Efficacy for Symptom Management

Change in quality of life

Other study objectives

Change in Parenting Concerns

Change in Psychological Services

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: mHealth Coping Skills Training for Symptom Management (mCOPE)Experimental Treatment1 Intervention

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.

Group II: Standard CareActive Control1 Intervention

Standard Care group will complete assessment questionnaires at the same time points as mCOPE, but will not receive mCOPE protocol.

0 / 3Eligibility criteria met