Colorectal CancerNCT02706301
Pain Coping Skills for Colorectal Cancer Survivors
A study testing Telephone-Based Coping Skills Training (CST) in people with Colorectal Cancer, run by Duke University at 1 site in United States.
Trial summary
Colorectal cancer survivors experience long-term negative physical and psychosocial consequences of their disease. There is a critical need to develop novel behavioral interventions for improving colorectal cancer survivor outcomes. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Telephone-Based Coping Skills Training (CST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Oct 2018
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >21 years old
- personal history of colorectal cancer
- finished active cancer treatment within the past 12 months
- reported pain as a concern as well as psychological distress on a National Comprehensive Cancer Network screener
- able to speak and read English
- able and willing to give informed consent
Who cannot join
- currently undergoing active cancer treatment
- have a major mental illness (e.g., schizophrenia)
- have a mental illness that is not being treated/controlled (e.g., bipolar disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Coping Skills Training for Colorectal Cancer Survivors With Pain and Distress
Colorectal cancer survivors experience long-term negative physical and psychosocial consequences of their disease. There is a critical need to develop novel behavioral interventions for improving colorectal cancer survivor outcomes. The investigators have developed a pain management intervention for colorectal cancer survivors that focuses on addressing both pain and psychological distress. Colorectal cancer survivors who endorse pain and comorbid psychological distress as a concern during a clinic-based survivorship care consult will be recruited. Participants will be randomized into either: Telephone-Based Coping Skills Training (CST) for pain and comorbid psychological distress or standard care. The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring) relevant to managing pain and psychological distress. The standard care control condition will receive resources and referrals related to managing survivorship health.
- Conditions
- Colorectal Cancer
- Being tested
- Telephone-Based Coping Skills Training (CST)
- Keywords
- colorectal cancer survivor, cancer pain, psychological distress, coping skills training, symptom management, cancer survivorship
- Medical subject headings
- Colorectal Neoplasms, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-Based Coping Skills Training (CST)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Telephone-Based Coping Skills Training (CST) | Experimental | The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring) relevant to managing pain as well as psychological distress. Receives: Behavioral: Telephone-Based Coping Skills Training (CST) |
| Standard care control | No intervention | The standard care control condition will receive resources and referrals related to survivorship health. This information will be provided to the participant during their initial survivorship care consult. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Severity assessed using the Brief Pain Inventory (BPI)
Brief Pain Inventory (BPI)
Measured: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
Secondary outcomes (3)
Change in Psychological Distress assessed using the Brief Symptom Inventory (BSI)
Brief Symptom Inventory (BSI)
Measured: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
Change in Quality of Life assessed using the FACT-G, version 4.0
The Functional Assessment of Cancer Therapy - General (FACT-G), version 4.0
Measured: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
Change in Self-Efficacy for Pain Control assessed using the subscale of the Chronic Pain Self-Efficacy Scale
Self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale
Measured: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2018
- Study completionOct 2018
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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Sarah A. Kelleher, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706301
- Sponsor's protocol ID
- Pro00063330
- Status last verified
- Nov 2018
- First submitted
- 8 Mar 2016
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Coping Skills Training for Colorectal Cancer Survivors With Pain and Distress
- ClinicalTrials.gov ID
- NCT02706301
- Acronym / sponsor ID
- Pro00063330
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer survivor, cancer pain, psychological distress, coping skills training, symptom management, cancer survivorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 11 Mar 2016 (estimated)
- 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.
Colorectal cancer survivors experience long-term negative physical and psychosocial consequences of their disease. There is a critical need to develop novel behavioral interventions for improving colorectal cancer survivor outcomes. The investigators have developed a pain management intervention for colorectal cancer survivors that focuses on addressing both pain and psychological distress. Colorectal cancer survivors who endorse pain and comorbid psychological distress as a concern during a clinic-based survivorship care consult will be recruited. Participants will be randomized into either: Telephone-Based Coping Skills Training (CST) for pain and comorbid psychological distress or standard care. The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring) relevant to managing pain and psychological distress. The standard care control condition will receive resources and referrals related to managing survivorship health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone-Based Coping Skills Training (CST) | Experimental | Behavioral: Telephone-Based Coping Skills Training (CST)The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring) relevant to managing pain as well as psychological distress. |
| Standard care control | No intervention | –The standard care control condition will receive resources and referrals related to survivorship health. This information will be provided to the participant during their initial survivorship care consult. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >21 years old
- personal history of colorectal cancer
- finished active cancer treatment within the past 12 months
- reported pain as a concern as well as psychological distress on a National Comprehensive Cancer Network screener
- able to speak and read English
Key exclusion criteria (3 listed)
- currently undergoing active cancer treatment
- have a major mental illness (e.g., schizophrenia)
- have a mental illness that is not being treated/controlled (e.g., bipolar disorder)
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 |
|---|---|---|
| Telephone-Based Coping Skills Training (CST) | Behavioural | Telephone-Based Coping Skills Training (CST) |
Primary outcome
Change in Pain Severity assessed using the Brief Pain Inventory (BPI)
Time frame: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
Brief Pain Inventory (BPI)
3 secondary outcomes
Change in Psychological Distress assessed using the Brief Symptom Inventory (BSI)
Time frame: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
Change in Quality of Life assessed using the FACT-G, version 4.0
Time frame: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
Change in Self-Efficacy for Pain Control assessed using the subscale of the Chronic Pain Self-Efficacy Scale
Time frame: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
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 17 Jan 2019.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-Based Coping Skills Training (CST) in people with Colorectal Cancer, run by Duke University at 1 site 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 6 inclusion and 3 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 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 assessed using the Brief Pain Inventory (BPI) (time frame: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)). 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 17 Jan 2019.