Pain Coping Skills for Colorectal Cancer Survivors

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Telephone-Based Coping Skills Training (CST)

• Registration Number: NCT02706301
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-10
• Study First Posted: 2016-03-11
• Study Start: 2016-07
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2018-11
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telephone-Based Coping Skills Training (CST)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

Duke Cancer Institute; 🇺🇸 Durham, North Carolina, United States