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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone-Based Coping Skills Training (CST) | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Severity assessed using the Brief Pain Inventory (BPI) | Brief Pain Inventory (BPI) | pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Psychological Distress assessed using the Brief Symptom Inventory (BSI) | Brief Symptom Inventory (BSI) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction assessed using the Client Satisfaction Questionnaire 10-item version | Client Satisfaction Questionnaire 10-item version. | Post-treatment (approximately 8 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah A. Kelleher, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Cancer Institute | Durham | North Carolina | 27701 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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The Functional Assessment of Cancer Therapy - General (FACT-G), version 4.0 |
| 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 | pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks) |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |