Clinical trial NCT05067556: Decreasing Long-term Opioid Use in Cancer Survivors
Official title: Creating a Pathway for Disease-Free Cancer Survivors to Decrease Long-term Opioid Use
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Pain
Chronic Pain
Cancer Pain
Survivorship
Keywords: Commitment Therapy
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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 \[DAST-10\])
* Anyone scoring \>=8 on ORT indicating very high risk for opioid abuse

Primary outcomes:
measure: Recruitment yield of participants contacted
timeFrame: 12 Months
measure: Recruitment yield of participants consented
timeFrame: 12 Months
measure: Recruitment yield number of participants enrolled
timeFrame: 12 Months
measure: Session Attendance
timeFrame: 6 Weeks
measure: Participant Satisfaction
timeFrame: 6 Weeks
Secondary outcomes:
measure: Pain Intensity
timeFrame: 6 Weeks
measure: Opioid Use Frequency
timeFrame: 6 Weeks
measure: Pain interference
timeFrame: 6 Weeks
measure: Opioid Refill Frequency
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Susan Hong, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: