Decreasing Long-term Opioid Use in Cancer Survivors

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

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

Study Overview

• Status: Suspended
• Conditions: Pain; Chronic Pain; Cancer Pain; Survivorship
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy for chronic pain (ACT-CP)

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 Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Acceptance and Commitment Therapy for Chronic Pain (ACT-CP)	Behavioral: Acceptance and Commitment Therapy for chronic pain (ACT-CP); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Susan Hong, MD, MPH, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Commitment Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain; Chronic Pain
• Other Study ID Numbers: MCC-21-18366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data at this time

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No