Colorectal Cancer
Conditions
Keywords
colorectal cancer survivor, cancer pain, psychological distress, coping skills training, symptom management, cancer survivorship
Brief 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. 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.
Interventions
BEHAVIORALTelephone-Based Coping Skills Training (CST)
Sponsors
American Cancer Society, Inc.
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* \>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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Severity assessed using the Brief Pain Inventory (BPI) | pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks) | Brief Pain Inventory (BPI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Psychological Distress assessed using the Brief Symptom Inventory (BSI) | pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks) | Brief Symptom Inventory (BSI) |
| Change in Quality of Life assessed using the FACT-G, version 4.0 | pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks) | The Functional Assessment of Cancer Therapy - General (FACT-G), version 4.0 |
| Change in Self-Efficacy for Pain Control assessed using the subscale of the Chronic Pain Self-Efficacy Scale | pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks) | Self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction assessed using the Client Satisfaction Questionnaire 10-item version | Post-treatment (approximately 8 weeks) | Client Satisfaction Questionnaire 10-item version. |
Countries
United States
Outcome results
None listed