An mHealth Symptom Management Intervention for Colorectal Cancer Patients (mCOPE)

NCT04763174 | Completed

• 1 other identifier: Pro00107498
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

cancer; pain; fatigue; distress; coping; mHealth; symptom management

Outcome Measures

Primary Outcomes (3)

• Change in pain severity

  Pain Severity will be assessed using the Brief Pain Inventory (BPI) by asking patients about worst, least, average and now pain on a 0 = no pain to 10 = pain as bad as you can imagine.

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

• Change in fatigue

  The Patient Reported Outcomes Measurement Information System (PROMIS) seven-item Fatigue Scale is a self-report measure of fatigue symptoms. Items ask patients to evaluate symptoms from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one's ability to carry out daily activities.

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

• Change in psychological distress

  The Brief Symptom Inventory (BSI) will be used to measure psychological distress. Responses are rated on a 5-point scale where 0=not at all and 4=extremely for questions such as "feeling not interested in things" and "feeling hopeless about the future."

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

Secondary Outcomes (2)

• Change in quality of life

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

• Change in Self-Efficacy for Symptom Management

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

Other Outcomes (2)

• Change in Psychological Services

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

• Change in Parenting Concerns

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

Study Arms (2)

mHealth Coping Skills Training for Symptom Management (mCOPE)

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.

Behavioral: mHealth Coping Skills Training for Symptom Management (mCOPE)

Standard Care

NO INTERVENTION

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

Interventions

mHealth Coping Skills Training for Symptom Management (mCOPE) BEHAVIORAL

mCOPE participants will complete 5 videoconferencing sessions (within 5-9 weeks) with a psychologist, each lasting 45-60 minutes, from a location convenient to the patient (e.g., home, work). Sessions will include cognitive behavioral coping skills designed to target pain, fatigue and psychological distress symptoms unique to colorectal cancer patients. mCOPE will include a mobile app for: 1) coping skills content (e.g., audio, video), 2) daily symptoms assessment and coping skills use tracking transmitting in real-time to study staff, and 4) push notifications for reminders, encouragement, and personalized feedback.

mHealth Coping Skills Training for Symptom Management (mCOPE)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Duke Regional Hospital

Durham, North Carolina, 27704, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms; Pain; Fatigue

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sarah A Kelleher, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: September 15, 2021
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)