Cancer Pain, Chronic Pain, Pain, Survivorship
Conditions
Keywords
Commitment Therapy
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.
Interventions
BEHAVIORALAcceptance 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.
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Recruitment yield of participants contacted | 12 Months | Study feasibility will be assessed by tracking the number of patients contacted |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Opioid Refill Frequency | 6 Weeks | Frequency of opioid refills will be assessed via pharmacy records available in patients' EMR |
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSusan Hong, MD, MPH
Virginia Commonwealth University
Outcome results
None listed