mHealth App for Colorectal Cancer

Recruiting at 1 trial location

Overseen By Sarah A Kelleher, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Cognitive impairment, Severe psychiatric condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

167 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators have developed an innovative mobile health (mHealth) coping skills training protocol, mCOPE, that is adapted to meet the multiple symptom needs and stage-of-life challenges faced by young and middle-aged adults with cancer, and delivered in a convenient and flexible format that does not incur further demands. Young and middle-aged colorectal cancer patients who report pain, fatigue, and psychological distress will be invited to participate in the study. Participants will be randomly assigned to one of two conditions: mCOPE or standard care. mCOPE will teach patients coping skills to manage their cancer-related symptoms (pain, fatigue and distress) in the context of unique age-related challenges; session content will be tailored based on participants' report. mCOPE sessions will be delivered via videoconferencing to the patient in his/her own environment and scheduled at times that are convenient to the patient. 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 real-time feedback to patients. Investigators want to understand the impact of the mCOPE intervention delivered to young and middle-aged colorectal cancer patients with pain, fatigue, and distress. mCOPE is expected to lead to reduced symptom severity and improved quality of life. Study aims include: testing the efficacy of mCOPE for improving symptoms and quality of life and examining improved self-efficacy for symptom management as a mediator of symptom severity.

Who Is on the Research Team?

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.

Exclusion Criteria

Cognitive impairment (e.g., dementia)

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

Inability to converse in English

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?

Group I: mHealth Coping Skills Training for Symptom Management (mCOPE) Experimental Treatment 1 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 Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+