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Suspended

NCT Number: NCT05067556

Decreasing Long-term Opioid Use in Cancer Survivors

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

Why the study stopped: Insufficient staffing
Suspended

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Key information

Conditions

Pain Cancer Pain Chronic Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Survivorship

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Recruitment yield of participants contacted

    Time frame: 12 Months

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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Pain Intensity

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 6 Weeks

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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Oct 5, 2021
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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