Decreasing Long-term Opioid Use in Cancer Survivors
Primary Purpose
Pain, Chronic Pain, Cancer Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy for chronic pain (ACT-CP)
Sponsored by
About this trial
This is an interventional other trial for Pain focused on measuring Commitment Therapy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of stage I-III cancer of any type, currently in remission, having completed active primary therapy. Patients on oral adjuvant hormone therapy will still be eligible.
- Self-reported cancer pain for >= 3 months
- Regular (at least weekly) opioid use as prescribed by physician for cancer-related pain for at least 6 months beyond completion of their cancer treatment.
- Average dose of opioid medication >= 20 MME (morphine milligram equivalents) daily.
- VCUHealth system patient
Exclusion Criteria:
- History of opioid use prior to cancer diagnosis
- Prior history of substance use disorder or currently enrolled in a methadone program.
- Serious mental illness and/or cognitive concerns that would prevent meaningful engagement in treatment
Sites / Locations
- Virginia Commonwealth UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Acceptance and Commitment Therapy for Chronic Pain (ACT-CP)
Outcomes
Primary Outcome Measures
Recruitment yield of participants contacted
Study feasibility will be assessed by tracking the number of patients contacted
Recruitment yield of participants consented
Study feasibility will be assessed by tracking the number of participants that consent to enroll in the trial.
Recruitment yield number of participants enrolled
Study feasibility will be assessed by recruitment yield, i.e., tracking the number of participants who initiated treatment.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Opioid Refill Frequency
Frequency of opioid refills will be assessed via pharmacy records available in patients' EMR
Full Information
NCT ID
NCT05067556
First Posted
September 16, 2021
Last Updated
August 8, 2023
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT05067556
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic Pain, Cancer Pain, Survivorship
Keywords
Commitment Therapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Acceptance and Commitment Therapy for Chronic Pain (ACT-CP)
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy for chronic pain (ACT-CP)
Intervention Description
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 Outcome Measure Information:
Title
Recruitment yield of participants contacted
Description
Study feasibility will be assessed by tracking the number of patients contacted
Time Frame
12 Months
Title
Recruitment yield of participants consented
Description
Study feasibility will be assessed by tracking the number of participants that consent to enroll in the trial.
Time Frame
12 Months
Title
Recruitment yield number of participants enrolled
Description
Study feasibility will be assessed by recruitment yield, i.e., tracking the number of participants who initiated treatment.
Time Frame
12 Months
Title
Session Attendance
Description
Study feasibility will be assessed by tracking the number of participants attend each intervention session over the course of the 6-week intervention period.
Time Frame
6 Weeks
Title
Participant Satisfaction
Description
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.
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
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.
Time Frame
6 Weeks
Title
Opioid Use Frequency
Description
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.
Time Frame
6 Weeks
Title
Pain interference
Description
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.
Time Frame
6 Weeks
Title
Opioid Refill Frequency
Description
Frequency of opioid refills will be assessed via pharmacy records available in patients' EMR
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Autumn Lanoye, PhD
Phone
804-828-4929
Email
autumn.lanoye@vcuhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Hong, MD, MPH
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Autumn Lanoye, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data at this time
Learn more about this trial
Decreasing Long-term Opioid Use in Cancer Survivors
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