Decreasing Long-term Opioid Use in Cancer Survivors

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05067556
• Other study ID #: MCC-21-18366
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: March 30, 2028

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: Autumn Lanoye, PhD
• Phone: 804-828-4929
• Email: autumn.lanoye[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: March 30, 2028
• Est. primary completion date: March 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Pain
• Chronic Pain
• Pain
• Survivorship

Intervention

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment yield of participants contacted	Study feasibility will be assessed by tracking the number of patients contacted	12 Months
Primary	Recruitment yield of participants consented	Study feasibility will be assessed by tracking the number of participants that consent to enroll in the trial.	12 Months
Primary	Recruitment yield number of participants enrolled	Study feasibility will be assessed by recruitment yield, i.e., tracking the number of participants who initiated treatment.	12 Months
Primary	Session Attendance	Study feasibility will be assessed by tracking the number of participants attend each intervention session over the course of the 6-week intervention period.	6 Weeks
Primary	Participant Satisfaction	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.	6 Weeks
Secondary	Pain Intensity	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.	6 Weeks
Secondary	Opioid Use Frequency	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.	6 Weeks
Secondary	Pain interference	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.	6 Weeks
Secondary	Opioid Refill Frequency	Frequency of opioid refills will be assessed via pharmacy records available in patients' EMR	6 Weeks