Decreasing Long-term Opioid Use in Cancer Survivors

Study Overview
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Brief Summary
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This is a feasibility pilot trial assessing a behavioral intervention for chronic pain among disease-free cancer survivors to decrease long-term opioid dependence.

Detailed Description
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To assess the feasibility and acceptability of implementing brief Acceptance and Commitment Therapy for chronic pain (ACT-CP) in a Survivorship clinic.

Official Title
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Creating a Pathway for Disease-Free Cancer Survivors to Decrease Long-term Opioid Use

Conditions
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Pain, Chronic Pain, Cancer Pain, Survivorship

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy for chronic pain (ACT-CP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cancer of any type, currently in remission, having completed active primary therapy. Patients on oral adjuvant hormone therapy will still be eligible. Completed active therapy must have been curative in intent (for example stage IV cancer patients such as head and neck cancer patients treated with curative intent are eligible). Self-reported cancer pain for >= 3 months Opioid use >= 5MME/day (morphine milligram equivalents) as prescribed by physician for cancer-related pain for at least 6 months beyond completion of their cancer treatment VCUHealth system patient Exclusion Criteria: History of opioid use prior to cancer diagnosis Anyone with prior history of substance use disorder or currently enrolled in a methadone program Anyone with schizophrenia or bipolar disorder Current utilization of psychotherapy services for pain, depression, anxiety, and/or PTSD Cognitive concerns that would prevent meaningful engagement in treatment Inability to converse in English Lack of working telephone and Internet connection (must have at least one or the other) Anyone found to have progression of cancer Anyone diagnosed with cancer recurrence or new cancer during their study period Documented diagnosis of or positive screen for current substance use disorder (score >5 on the Drug Abuse Screening Test-10 [DAST-10]) Anyone scoring >=8 on ORT indicating very high risk for opioid abuse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Acceptance and Commitment Therapy for Chronic Pain (ACT-CP) | Behavioral: Acceptance and Commitment Therapy for chronic pain (ACT-CP)<br>* Delivered virtually via Zoom or via telephone on an individual level; 30-minute sessions led by a trained psychologist and occur weekly for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment yield of participants contacted | Study feasibility will be assessed by tracking the number of patients contacted | 12 Months | 
| Recruitment yield of participants consented | Study feasibility will be assessed by tracking the number of participants that consent to enroll in the trial. | 12 Months | 
| Recruitment yield number of participants enrolled | Study feasibility will be assessed by recruitment yield, i.e., tracking the number of participants who initiated treatment. | 12 Months | 
| Session Attendance | Study feasibility will be assessed by tracking the number of participants attend each intervention session over the course of the 6-week intervention period. | 6 Weeks | 
| Participant Satisfaction | Study acceptability will be assessed by administering a post-intervention satisfaction survey which asks about satisfaction with the program including perceived efficacy and suggestions for improvement. | 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Preliminary efficacy of acceptance and commitment therapy for chronic pain (ACT-CP) will be assessed by analyzing change in self-reported pain scores using The Patient-Reported Outcome Measurement Information System short form 3a v1.0 (PROMIS). This tool measures how much a person hurts. | 6 Weeks | 
| Opioid Use Frequency | Preliminary efficacy of acceptance and commitment therapy for chronic pain (ACT-CP) will be assessed by self-reported opioid use frequency weekly throughout the intervention period. | 6 Weeks | 
| Pain interference | Preliminary efficacy of acceptance and commitment therapy for chronic pain (ACT-CP) will be assessed by analyzing pain interference using the PROMIS short form 8a. The PROMIS Pain Interference instrument measures the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. | 6 Weeks | 
| Opioid Refill Frequency | Frequency of opioid refills will be assessed via pharmacy records available in patients' EMR | 6 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Commitment Therapy