Pain Coping Skills for Colorectal Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Telephone-Based Coping Skills Training (CST)

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Duke Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Telephone-Based Coping Skills Training (CST)
No Intervention: Standard care control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Other Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Sarah A. Kelleher, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: March 10, 2016
• First Posted (Estimate): March 11, 2016

Study Record Updates

• Last Update Posted (Actual): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: symptom management; psychological distress; cancer pain; cancer survivorship; coping skills training; colorectal cancer survivor
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Pro00063330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO