Clinical trial NCT02706301: Pain Coping Skills for Colorectal Cancer Survivors
Official title: Pain Coping Skills Training for Colorectal Cancer Survivors With Pain and Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer survivor
cancer pain
psychological distress
coping skills training
symptom management
cancer survivorship
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2016-03-11
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in Pain Severity assessed using the Brief Pain Inventory (BPI)
timeFrame: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
Secondary outcomes:
measure: Change in Psychological Distress assessed using the Brief Symptom Inventory (BSI)
timeFrame: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
measure: Change in Quality of Life assessed using the FACT-G, version 4.0
timeFrame: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
measure: Change in Self-Efficacy for Pain Control assessed using the subscale of the Chronic Pain Self-Efficacy Scale
timeFrame: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)
Other outcomes:
measure: Patient Satisfaction assessed using the Client Satisfaction Questionnaire 10-item version
timeFrame: Post-treatment (approximately 8 weeks)
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Sarah A. Kelleher, PhD
role: PRINCIPAL_INVESTIGATOR
References: