Decreasing Long-term Opioid Use in Cancer Survivors

NCT05067556 | Suspended

• 1 other identifier: MCC-21-18366
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Chronic Pain; Cancer Pain; Survivorship

Keywords

Commitment Therapy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Pain Intensity

  6 Weeks

• Opioid Use Frequency

  6 Weeks

• Pain interference

  6 Weeks

• Opioid Refill Frequency

  6 Weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Acceptance and Commitment Therapy for Chronic Pain (ACT-CP)

Behavioral: Acceptance and Commitment Therapy for chronic pain (ACT-CP)

Interventions

Acceptance and Commitment Therapy for chronic pain (ACT-CP) BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Pain; Chronic Pain; Cancer Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan Hong, MD, MPH

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 5, 2021
• Study Start: December 20, 2021
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)