Pain Coping Skills for Colorectal Cancer Survivors

NCT02706301 | Completed DMC

• 1 other identifier: Pro00063330
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer survivor; cancer pain; psychological distress; coping skills training; symptom management; cancer survivorship

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• 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)

• 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)

Other Outcomes (1)

• Patient Satisfaction assessed using the Client Satisfaction Questionnaire 10-item version

  Post-treatment (approximately 8 weeks)

Study Arms (2)

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.

Behavioral: Telephone-Based Coping Skills Training (CST)

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.

Interventions

Telephone-Based Coping Skills Training (CST) BEHAVIORAL

Telephone-Based Coping Skills Training (CST)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Cancer Pain

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah A. Kelleher, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 11, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 17, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)