Colorectal CancerNCT04763174
An mHealth Symptom Management Intervention for Colorectal Cancer Patients (mCOPE)
A study testing mHealth Coping Skills Training for Symptom Management (mCOPE) in people with Colorectal Cancer, run by Duke University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- mHealth Coping Skills Training for Symptom Management (mCOPE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2021to 6 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Regional Hospital
Durham, North Carolina, 27704
Duke Cancer Institute
Durham, North Carolina, 27705
About this study
Official title: An mHealth Symptom Management Intervention for Colorectal Cancer Patients
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.
Read the 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 (i.e., 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 (e.g., 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 (e.g., 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 (e.g., 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.
- Conditions
- Colorectal Cancer
- Being tested
- mHealth Coping Skills Training for Symptom Management (mCOPE)
- Keywords
- cancer, pain, fatigue, distress, coping, mHealth, symptom management
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Coping Skills Training for Symptom Management (mCOPE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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."
Measured: 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
The Functional Assessment of Cancer Therapy - General (FACT-G), version 4.0, is a 27-item self-report measure that assesses quality of life concerns specific to cancer patients. FACT-G is comprised of four quality of life domains including physical, social/family, emotional, and functional well-being.
Measured: 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
Self-Efficacy for Symptom Management will be assessed using the Patient Reported
Measured: Baseline, post-intervention (up to 10 weeks post-intervention), 3-month, and 6-month: approximately 20 minutes each time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start15 Sep 2021
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah A Kelleher, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763174
- Sponsor's protocol ID
- Pro00107498
- Status last verified
- Jan 2025
- First submitted
- 17 Feb 2021
- Last updated
- 16 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An mHealth Symptom Management Intervention for Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT04763174
- Acronym / sponsor ID
- Pro00107498
- Conditions
- Colorectal Cancer
- Keywords
- cancer, pain, fatigue, distress, coping, mHealth, symptom management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (i.e., 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 (e.g., 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 (e.g., 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 (e.g., 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth Coping Skills Training for Symptom Management (mCOPE) | Experimental | Behavioral: mHealth Coping Skills Training for Symptom Management (mCOPE)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. |
| Standard Care | No intervention | –Standard Care group will complete assessment questionnaires at the same time points as mCOPE, but will not receive mCOPE protocol. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth Coping Skills Training for Symptom Management (mCOPE)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. | Behavioural | mHealth Coping Skills Training for Symptom Management (mCOPE) |
Primary outcome
Change in pain severity
Time frame: Baseline, post-intervention (up to 10 weeks post-intervention), 3-month, and 6-month: approximately 20 minutes each time.
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.
Change in fatigue
Time frame: Baseline, post-intervention (up to 10 weeks post-intervention), 3-month, and 6-month: approximately 20 minutes each time.
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.
Change in psychological distress
Time frame: Baseline, post-intervention (up to 10 weeks post-intervention), 3-month, and 6-month: approximately 20 minutes each time.
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."
2 secondary outcomes
Change in quality of life
Time frame: 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
Time frame: Baseline, post-intervention (up to 10 weeks post-intervention), 3-month, and 6-month: approximately 20 minutes each time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah A Kelleher, PhD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Coping Skills Training for Symptom Management (mCOPE) in people with Colorectal Cancer, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain severity (time frame: Baseline, post-intervention (up to 10 weeks post-intervention), 3-month, and 6-month: approximately 20 minutes each time.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.