Decreasing Long-term Opioid Use in Cancer Survivors

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05067556
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 10.3
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Chronic Pain; Cancer Pain; Survivorship	Behavioral: Acceptance and Commitment Therapy for chronic pain (ACT-CP)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Creating a Pathway for Disease-Free Cancer Survivors to Decrease Long-term Opioid Use
• Actual Study Start Date: Dec 20, 2021
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Oct 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Recruitment yield of participants contacted [12 Months]

   Study feasibility will be assessed by tracking the number of patients contacted

2. 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.

3. 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.

4. 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.

5. 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.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. Opioid Refill Frequency [6 Weeks]

   Frequency of opioid refills will be assessed via pharmacy records available in patients' EMR

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of stage I-III cancer of any type, currently in remission, having completed active primary therapy. Patients on oral adjuvant hormone therapy will still be eligible.

• Self-reported cancer pain for >= 3 months

• Regular (at least weekly) opioid use as prescribed by physician for cancer-related pain for at least 6 months beyond completion of their cancer treatment.

• Average dose of opioid medication >= 20 MME (morphine milligram equivalents) daily.

• VCUHealth system patient

Exclusion Criteria:

• History of opioid use prior to cancer diagnosis

• Prior history of substance use disorder or currently enrolled in a methadone program.

• Serious mental illness and/or cognitive concerns that would prevent meaningful engagement in treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University	Richmond	Virginia	United States	23219

Sponsors and Collaborators

• Virginia Commonwealth University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT05067556
• Other Study ID Numbers: MCC-21-18366
• First Posted: Oct 5, 2021
• Last Update Posted: Jan 11, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Virginia Commonwealth University: Commitment Therapy
• Additional relevant MeSH terms: Chronic Pain; Cancer Pain

Study Results

No Results Posted as of Jan 11, 2022