Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04763174
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2021-02-17
Brief Title:
An mHealth Symptom Management Intervention for Colorectal Cancer Patients mCOPE
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
An mHealth Symptom Management Intervention for Colorectal Cancer Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hisher 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
Detailed Description:
There is a high level of evidence that suggests cognitive and behavioral factors play an important role in colorectal cancer patients abilities to cope with pain fatigue and distress Patients with multiple persistent symptoms may be particularly likely to have low confidence in their ability to control their symptoms ie self-efficacy for symptom management Cognitive behavioral coping skills protocols can enhance patients abilities to cope with their symptoms in the context of age-related challenges to date these protocols have been tested in older patients and neither intervention content nor delivery modality meet the needs of younger patients
Intervention protocols aimed at young and middle-aged patients dealing with age-related stressors and high time demands must be adapted to meet the needs and challenges eg coping skills practice strategies within the context of competing demands communication with others about symptoms and limitations relaxation for managing stoma-related pain activity pacing to manage fatigue due to cancer and the demands of multiple life roles cognitive restructuring negative thoughts surrounding managing time off work for treatment while maintaining health insurance and arranging childcare of younger adults with cancer and delivered in a format eg videoconferencing adjunctive mobile app that is acceptable and does not incur further demands
The investigators propose to use a randomized controlled trial RCT to test an innovative mHealth Coping Skills Training for Symptom Management mCOPE intervention designed to target pain fatigue psychological distress and quality of life with unique content adapted for young and middle-aged colorectal cancer patients mCOPE will be delivered with convenient mHealth modalities videoconferencing mobile app supported Young and middle-aged adults with colorectal cancer that endorse multiple symptoms will be randomized to 1 mCOPE or 2 standard care mCOPE includes 5 videoconferencing sessions of a cognitive behavior theory-based protocol that teaches coping skills eg relaxation activity pacing cognitive restructuring relevant to managing pain fatigue and distress and improving quality of life in the context of the unique challenges facing younger patients mCOPE uses mHealth technology including a mobile app to capture daily symptom and coping skills use data and provide personalized support and feedback to patients The central hypothesis is that mCOPE will result in decreased pain fatigue and distress and increased quality of life
Specific study aims are
Aim 1 Test the efficacy of mCOPE for improving symptoms and quality of life
Aim 2 Examine improved self-efficacy for symptom management as a mediator of symptom severity
Intervention protocols aimed at young and middle-aged patients dealing with age-related stressors and high time demands must be adapted to meet the needs and challenges eg coping skills practice strategies within the context of competing demands communication with others about symptoms and limitations relaxation for managing stoma-related pain activity pacing to manage fatigue due to cancer and the demands of multiple life roles cognitive restructuring negative thoughts surrounding managing time off work for treatment while maintaining health insurance and arranging childcare of younger adults with cancer and delivered in a format eg videoconferencing adjunctive mobile app that is acceptable and does not incur further demands
The investigators propose to use a randomized controlled trial RCT to test an innovative mHealth Coping Skills Training for Symptom Management mCOPE intervention designed to target pain fatigue psychological distress and quality of life with unique content adapted for young and middle-aged colorectal cancer patients mCOPE will be delivered with convenient mHealth modalities videoconferencing mobile app supported Young and middle-aged adults with colorectal cancer that endorse multiple symptoms will be randomized to 1 mCOPE or 2 standard care mCOPE includes 5 videoconferencing sessions of a cognitive behavior theory-based protocol that teaches coping skills eg relaxation activity pacing cognitive restructuring relevant to managing pain fatigue and distress and improving quality of life in the context of the unique challenges facing younger patients mCOPE uses mHealth technology including a mobile app to capture daily symptom and coping skills use data and provide personalized support and feedback to patients The central hypothesis is that mCOPE will result in decreased pain fatigue and distress and increased quality of life
Specific study aims are
Aim 1 Test the efficacy of mCOPE for improving symptoms and quality of life
Aim 2 Examine improved self-efficacy for symptom management as a mediator of symptom severity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None