Pain Coping Skills for Colorectal Cancer Survivors

Colorectal Cancer Clinical Trial

Official title:

Pain Coping Skills Training for Colorectal Cancer Survivors With Pain and Distress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706301
• Other study ID #: Pro00063330
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: October 2018

Study information

• Verified date: November 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Telephone-Based Coping Skills Training (CST)

Locations

Country	Name	City	State
United States	Duke Cancer Institute	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction assessed using the Client Satisfaction Questionnaire 10-item version	Client Satisfaction Questionnaire 10-item version.	Post-treatment (approximately 8 weeks)
Primary	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)
Secondary	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)
Secondary	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	pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
Secondary	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)