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Clinical Trials/NCT05067556
NCT05067556
Suspended
Not Applicable

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

Virginia Commonwealth University1 site in 1 country18 target enrollmentDecember 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Virginia Commonwealth University
Enrollment
18
Locations
1
Primary Endpoint
Recruitment yield number of participants enrolled
Status
Suspended
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 20, 2021
End Date
March 30, 2028
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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 \[DAST-10\])

Outcomes

Primary Outcomes

Recruitment yield number of participants enrolled

Time Frame: 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

Time Frame: 12 Months

Study feasibility will be assessed by tracking the number of participants that consent to enroll in the trial.

Session Attendance

Time Frame: 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

Time Frame: 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

Time Frame: 12 Months

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

Secondary Outcomes

  • Opioid Use Frequency(6 Weeks)
  • Pain Intensity(6 Weeks)
  • Pain interference(6 Weeks)
  • Opioid Refill Frequency(6 Weeks)

Study Sites (1)

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