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Completed

NCT Number: NCT02706301

Pain Coping Skills for Colorectal Cancer Survivors

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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Key information

Conditions

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

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Cancer Institute

Durham, North Carolina, 27701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Telephone-Based Coping Skills Training (CST)

Behavioral

Primary outcomes

  1. Change in Pain Severity assessed using the Brief Pain Inventory (BPI)

    Time frame: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)

    Brief Pain Inventory (BPI)

Secondary outcomes

  1. Change in Psychological Distress assessed using the Brief Symptom Inventory (BSI)

    Time frame: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)

    Brief Symptom Inventory (BSI)

  2. Change in Quality of Life assessed using the FACT-G, version 4.0

    Time frame: 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

  3. Change in Self-Efficacy for Pain Control assessed using the subscale of the Chronic Pain Self-Efficacy Scale

    Time frame: 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

Other outcomes

  1. Patient Satisfaction assessed using the Client Satisfaction Questionnaire 10-item version

    Time frame: Post-treatment (approximately 8 weeks)

    Client Satisfaction Questionnaire 10-item version.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 11, 2016
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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