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Pain Coping Skills for Colorectal Cancer Survivors

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone-Based Coping Skills Training (CST)
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer survivor, cancer pain, psychological distress, coping skills training, symptom management, cancer survivorship

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Duke Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telephone-Based Coping Skills Training (CST)

Standard care control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 2016
Last Updated
January 16, 2019
Sponsor
Duke University
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02706301
Brief Title
Pain Coping Skills for Colorectal Cancer Survivors
Official Title
Pain Coping Skills Training for Colorectal Cancer Survivors With Pain and Distress
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer survivor, cancer pain, psychological distress, coping skills training, symptom management, cancer survivorship

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone-Based Coping Skills Training (CST)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Based Coping Skills Training (CST)
Primary Outcome Measure Information:
Title
Change in Pain Severity assessed using the Brief Pain Inventory (BPI)
Description
Brief Pain Inventory (BPI)
Time Frame
pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
Secondary Outcome Measure Information:
Title
Change in Psychological Distress assessed using the Brief Symptom Inventory (BSI)
Description
Brief Symptom Inventory (BSI)
Time Frame
pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
Title
Change in Quality of Life assessed using the FACT-G, version 4.0
Description
The Functional Assessment of Cancer Therapy - General (FACT-G), version 4.0
Time Frame
pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
Title
Change in Self-Efficacy for Pain Control assessed using the subscale of the Chronic Pain Self-Efficacy Scale
Description
Self-efficacy for pain management 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)
Other Pre-specified Outcome Measures:
Title
Patient Satisfaction assessed using the Client Satisfaction Questionnaire 10-item version
Description
Client Satisfaction Questionnaire 10-item version.
Time Frame
Post-treatment (approximately 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah A. Kelleher, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pain Coping Skills for Colorectal Cancer Survivors

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