Decreasing Long-term Opioid Use in Cancer Survivors

Not Applicable

Suspended

• Conditions: Survivorship; Cancer Pain; Chronic Pain; Pain
• Interventions: Behavioral: Acceptance and Commitment Therapy for chronic pain (ACT-CP)

• Registration Number: NCT05067556
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-05
• Study Start: 2021-12-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2028-03-30
• Study Completion: 2028-03-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Acceptance and Commitment Therapy for chronic pain (ACT-CP)	Acceptance and Commitment Therapy for Chronic Pain (ACT-CP)

Primary Outcome Measures

Name	Time	Method
Recruitment yield number of participants enrolled	12 Months	Study feasibility will be assessed by recruitment yield, i.e., tracking the number of participants who initiated treatment.
Recruitment yield of participants consented	12 Months	Study feasibility will be assessed by tracking the number of participants that consent to enroll in the trial.
Session Attendance	6 Weeks	Study feasibility will be assessed by tracking the number of participants attend each intervention session over the course of the 6-week intervention period.
Participant Satisfaction	6 Weeks	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.
Recruitment yield of participants contacted	12 Months	Study feasibility will be assessed by tracking the number of patients contacted

Secondary Outcome Measures

Name	Time	Method
Opioid Use Frequency	6 Weeks	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.
Pain Intensity	6 Weeks	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.
Pain interference	6 Weeks	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.
Opioid Refill Frequency	6 Weeks	Frequency of opioid refills will be assessed via pharmacy records available in patients' EMR

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States