Pain Coping Skills for Colorectal Cancer Survivors

Study Overview
=================
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.

Official Title
-----------------
Pain Coping Skills Training for Colorectal Cancer Survivors With Pain and Distress

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Behavioral: Telephone-Based Coping Skills Training (CST)


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone-Based Coping Skills Training (CST)<br>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)<br> <br> |
| No Intervention: Standard care control<br>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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal cancer survivor, cancer pain, psychological distress, coping skills training, symptom management, cancer survivorship