PainNCT05067556
Decreasing Long-term Opioid Use in Cancer Survivors
A study testing Acceptance and Commitment Therapy for chronic pain (ACT-CP) in people with Pain and Chronic Pain, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic Pain, Cancer Pain
- What is being tested?
- Acceptance and Commitment Therapy for chronic pain (ACT-CP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2021to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23219
About this study
Official title: Creating a Pathway for Disease-Free Cancer Survivors to Decrease Long-term Opioid Use
This is a feasibility pilot trial assessing a behavioral intervention for chronic pain among disease-free cancer survivors to decrease long-term opioid dependence.
Read the detailed description
To assess the feasibility and acceptability of implementing brief Acceptance and Commitment Therapy for chronic pain (ACT-CP) in a Survivorship clinic.
- Conditions
- Pain, Chronic Pain, Cancer Pain, Survivorship
- Being tested
- Acceptance and Commitment Therapy for chronic pain (ACT-CP)
- Keywords
- Commitment Therapy
- Medical subject headings
- Pain, Chronic Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy for chronic pain (ACT-CP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Acceptance and Commitment Therapy for Chronic Pain (ACT-CP) Receives: Behavioral: Acceptance and Commitment Therapy for chronic pain (ACT-CP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment yield of participants contacted
Study feasibility will be assessed by tracking the number of patients contacted
Measured: 12 Months
Recruitment yield of participants consented
Study feasibility will be assessed by tracking the number of participants that consent to enroll in the trial.
Measured: 12 Months
Recruitment yield number of participants enrolled
Study feasibility will be assessed by recruitment yield, i.e., tracking the number of participants who initiated treatment.
Measured: 12 Months
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.
Measured: 6 Weeks
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.
Measured: 6 Weeks
Secondary outcomes (4)
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.
Measured: 6 Weeks
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.
Measured: 6 Weeks
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.
Measured: 6 Weeks
Opioid Refill Frequency
Frequency of opioid refills will be assessed via pharmacy records available in patients' EMR
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start20 Dec 2021
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Why it stopped: Insufficient staffing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Hong, MD, MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067556
- Sponsor's protocol ID
- MCC-21-18366
- Status last verified
- Aug 2026
- First submitted
- 16 Sep 2021
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data at this time
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating a Pathway for Disease-Free Cancer Survivors to Decrease Long-term Opioid Use
- ClinicalTrials.gov ID
- NCT05067556
- Acronym / sponsor ID
- MCC-21-18366
- Conditions
- Pain, Chronic Pain, Cancer Pain, Survivorship
- Keywords
- Commitment Therapy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Insufficient staffing
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Acceptance and Commitment Therapy for chronic pain (ACT-CP)Acceptance and Commitment Therapy for Chronic Pain (ACT-CP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
Primary outcome
Recruitment yield of participants contacted
Time frame: 12 Months
Study feasibility will be assessed by tracking the number of patients contacted
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.
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.
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.
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.
4 secondary outcomes
Pain Intensity
Time frame: 6 Weeks
Opioid Use Frequency
Time frame: 6 Weeks
Pain interference
Time frame: 6 Weeks
Opioid Refill Frequency
Time frame: 6 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data at this time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Hong, MD, MPH principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy for chronic pain (ACT-CP) in people with Pain and Chronic Pain, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment yield of participants contacted (time frame: 12 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.