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mHealth App for Colorectal Cancer

N/A
Recruiting
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
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

Study 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.Check my eligibility
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.See study design
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.

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.
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fatigue
Change in pain severity
Change in psychological distress
Secondary outcome measures
Change in Self-Efficacy for Symptom Management
Change in quality of life
Other outcome measures
Change in Parenting Concerns
Change in Psychological Services

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.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,339 Total Patients Enrolled
Sarah A Kelleher, PhDPrincipal InvestigatorDuke University
2 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

mHealth Coping Skills Training for Symptom Management (mCOPE) Clinical Trial Eligibility Overview. Trial Name: NCT04763174 — N/A
Colorectal Cancer Research Study Groups: Standard Care, mHealth Coping Skills Training for Symptom Management (mCOPE)
Colorectal Cancer Clinical Trial 2023: mHealth Coping Skills Training for Symptom Management (mCOPE) Highlights & Side Effects. Trial Name: NCT04763174 — N/A
mHealth Coping Skills Training for Symptom Management (mCOPE) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04763174 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for participants in this research?

"As evidenced by clinicaltrials.gov, this research is actively enlisting participants since its post on September 15th 2021 and the latest update dated August 19th 2022."

Answered by AI

Could I potentially join this research study?

"Within the parameters of 18 to 50 years old and a diagnosis of colorectal cancer within three years, this medical study is recruiting 170 participants. All applicants must also be able to speak, read and comprehend English fluently along with displaying either pain, fatigue or psychological distress on an intensity scale of 3 or higher."

Answered by AI

What is the current enrollment rate for this trial?

"Affirmative. Data stored on clinicaltrials.gov evinces that this experiment, which was initially posted on September 15th 2021, is presently recruiting participants. Approximately 170 patients need to be enlisted from 2 study sites."

Answered by AI

Is the sample group for this clinical trial inclusive of elderly individuals?

"Patients included in this trial must range from 18 to 50 years old; for those under 18 or above 65, there are 38 and 1050 trials respectively."

Answered by AI

Who else is applying?

What site did they apply to?
Duke Regional Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
An mHealth Symptom Management Intervention for Colorectal Cancer Patients (mCOPE)
2021. "An mHealth Symptom Management Intervention for Colorectal Cancer Patients (mCOPE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04763174.
All > Colorectal Cancer Raleigh
~35 spots leftby Dec 2024
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