Substance UseACTIONNCT05643027
A Novel Intervention for Patients With Cancer
A study testing Acceptance and Commitment Therapy in people with Substance Use and Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is being done to develop an intervention for psychological symptoms that patients diagnosed with cancer may experience. Psychological symptoms may include thoughts, feelings, emotions, and memories The names of the study intervention and research activities involved in this study are/is: Acceptance… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Substance Use, Cancer, Psychological
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 11 May 2026
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old
- have an estimated survival time of at least 6 months (as estimated by palliative care provider)
- score at least 4 on the Opioid Risk Tool (ORT)
- have been diagnosed with any cancer, including hematologic malignancies
- performance status criterion of 0, 1, or 2 [ with 0 indicating that the patient is asymptomatic, 1 that the patient is symptomatic but fully ambulatory, and 2 that the patient is symptomatic and in bed <50% of the day]
Who cannot join
- Patients with a score at least 3 to ensure that all enrolled patients are able to participate in the intervention, complete assessments, ensure that no patients who are too sick to participate are enrolled; this will enhance the rigor of the study)
- currently be on opioid therapy
- not meet criteria for current substance use disorder
- assessed by the Diagnostic \& Statistical Manual of mental disorders; DSM-5 or be receiving substance use disorder treatment; and speak and comprehend English sufficiently to be able to participate in psychotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Novel Intervention for Avoidance-Related Opioid Misuse in Patients With Cancer
This research study is being done to develop an intervention for psychological symptoms that patients diagnosed with cancer may experience. Psychological symptoms may include thoughts, feelings, emotions, and memories
The names of the study intervention and research activities involved in this study are/is:
Read more
- Acceptance \& Commitment Therapy (ACT) for Cancer (involving 6 sessions with a licensed clinical psychologist)
- Questionnaires
- Post-study interview
Consistent with the NIH Stage Model for Behavioral Intervention Development, the investigators have adapted an existing, empirically-validated intervention, Acceptance and Commitment Therapy (ACT), to address substance use disorder risk during cancer care. The core components of ACT are particularly well-suited to address the psychological processes underlying opioid misuse in individuals treated for cancer pain. The overarching aim is to assess the feasibility and acceptability of the intervention by conducting a randomized pilot trial of the revised intervention ("ACTION") for cancer patients on opioid therapy, and at risk for SUD.
Read the detailed description
This research study is a Feasibility Study, which is the first-time investigators are examining this psychological intervention in patients with cancer who are prescribed opioids and are receiving palliative care. This study is being conducted to develop a psychological intervention designed specifically for individuals with cancer. The purpose of this study is to determine how practical this intervention is, to determine patient satisfaction, and test the study procedures. The aims are to:
- determine whether this intervention will be appropriate for further testing;
- identify which parts of the protocol and procedures need to be modified; and
- assess patients' reactions to this intervention.
This research study involves a psychological intervention for thoughts, feelings, emotions, and memories that individuals diagnosed with cancer may have.
The names of the study intervention and research activities involved in this study are/is:
- Acceptance \& Commitment Therapy (ACT) for Cancer (involving 6 sessions with a licensed clinical psychologist)
- Questionnaires
- Post-study interview
The research study procedures include: screening for eligibility and study treatment including evaluations, 6 visits, and a post-study interview.
Participants will be on this research study for up to 2 months.
It is expected that about 10 people will take part in this research study
- Conditions
- Substance Use, Cancer, Psychological
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- feasibility, acceptability
- Medical subject headings
- Substance-Related Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Six-session, skills-based behavioral intervention targeting risk factors for opioid use disorder in the context of cancer
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION FOR AVOIDANCE-RELATED OPIOID MISUSE | Other | Participants will participate in a six-session behavioral intervention, delivered by a licensed clinical psychologist. Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention, defined as an enrollment rate of at least 60%
enrollment rate of at least 60% and retention rate of at least 75%
Measured: 1 year
Acceptability of the intervention, measured by Client Satisfaction Questionnaire (CSQ-8) scores
Acceptability of the intervention, measured by CSQ-8 scores and patient reported feedback during exit interviews. On the CSQ-8, some items are reverse scored but higher scores mean greater satisfaction. Min value = 8, max value = 32
Measured: 1 year
Secondary outcomes (3)
Depression, measured by the Patient Health Questionnaire (PHQ-9)
patient reported depression symptoms, as measured by the PHQ-9; higher scores represent a worse outcome (i.e., more depression); min value = 1; max value = 27
Measured: 1 year
anxiety, as measured by the Generalized Anxiety Disorder questionnaire (GAD-7)
anxiety, as measured by the GAD-7; higher scores indicate a worse outcome (i.e., greater anxiety); min value = 0; max value = 21
Measured: 1 year
opioid misuse behaviors and consequences, as measured by the Current Opioid Misuse Measure (COMM)
opioid misuse behaviors and consequences, as measured by the COMM; with a sum of questions that is less than 9 reflecting no misuse and greater or equal to 9 reflecting misuse
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Mar 2023
- Primary completion11 May 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Miryam Yusufov, PhD, Dana-Farber Cancer Institute
- Investigators
- Miryam Yusufov, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643027
- Sponsor's protocol ID
- 21-587
- Other IDs
- 1K08CA259538-01A1
- Acronym
- ACTION
- Status last verified
- May 2026
- First submitted
- 31 May 2022
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Yusufov M, Pirl WF, Greer JA, Mazzola E, Dalrymple KL, Tulsky JA, Braun IM, McHugh RK. Study protocol for a pilot randomised controlled trial of a virtually delivered behavioural intervention (ACTION) for adults with cancer at risk for opioid use disorder. BMJ Open. 2024 Dec 5;14(12):e096546. doi: 10.1136/bmjopen-2024-096546.
PubMed 39638585
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Intervention for Avoidance-Related Opioid Misuse in Patients With Cancer
- ClinicalTrials.gov ID
- NCT05643027
- Acronym / sponsor ID
- ACTION / 21-587
- Conditions
- Substance Use, Cancer, Psychological
- Keywords
- feasibility, acceptability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 8 Dec 2022 (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 research study is being done to develop an intervention for psychological symptoms that patients diagnosed with cancer may experience. Psychological symptoms may include thoughts, feelings, emotions, and memories
The names of the study intervention and research activities involved in this study are/is:
- Acceptance \& Commitment Therapy (ACT) for Cancer (involving 6 sessions with a licensed clinical psychologist)
- Questionnaires
- Post-study interview
Consistent with the NIH Stage Model for Behavioral Intervention Development, the investigators have adapted an existing, empirically-validated intervention, Acceptance and Commitment Therapy (ACT), to address substance use disorder risk during cancer care. The core components of ACT are particularly well-suited to address the psychological processes underlying opioid misuse in individuals treated for cancer pain. The overarching aim is to assess the feasibility and acceptability of the intervention by conducting a randomized pilot trial of the revised intervention ("ACTION") for cancer patients on opioid therapy, and at risk for SUD.
Detailed description
This research study is a Feasibility Study, which is the first-time investigators are examining this psychological intervention in patients with cancer who are prescribed opioids and are receiving palliative care. This study is being conducted to develop a psychological intervention designed specifically for individuals with cancer. The purpose of this study is to determine how practical this intervention is, to determine patient satisfaction, and test the study procedures. The aims are to:
- determine whether this intervention will be appropriate for further testing;
- identify which parts of the protocol and procedures need to be modified; and
- assess patients' reactions to this intervention.
This research study involves a psychological intervention for thoughts, feelings, emotions, and memories that individuals diagnosed with cancer may have.
The names of the study intervention and research activities involved in this study are/is:
- Acceptance \& Commitment Therapy (ACT) for Cancer (involving 6 sessions with a licensed clinical psychologist)
- Questionnaires
- Post-study interview
The research study procedures include: screening for eligibility and study treatment including evaluations, 6 visits, and a post-study interview.
Participants will be on this research study for up to 2 months.
It is expected that about 10 people will take part in this research study
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION FOR AVOIDANCE-RELATED OPIOID MISUSE | Other | Behavioral: Acceptance and Commitment TherapyParticipants will participate in a six-session behavioral intervention, delivered by a licensed clinical psychologist. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- at least 18 years old
- have an estimated survival time of at least 6 months (as estimated by palliative care provider)
- score at least 4 on the Opioid Risk Tool (ORT)
- have been diagnosed with any cancer, including hematologic malignancies
- performance status criterion of 0, 1, or 2 [ with 0 indicating that the patient is asymptomatic, 1 that the patient is symptomatic but fully ambulatory, and 2 that the patient is symptomatic and in bed <50% of the day]
Key exclusion criteria (4 listed)
- Patients with a score at least 3 to ensure that all enrolled patients are able to participate in the intervention, complete assessments, ensure that no patients who are too sick to participate are enrolled; this will enhance the rigor of the study)
- currently be on opioid therapy
- not meet criteria for current substance use disorder
- assessed by the Diagnostic \& Statistical Manual of mental disorders; DSM-5 or be receiving substance use disorder treatment; and speak and comprehend English sufficiently to be able to participate in psychotherapy.
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 TherapySix-session, skills-based behavioral intervention targeting risk factors for opioid use disorder in the context of cancer | Behavioural | INTERVENTION FOR AVOIDANCE-RELATED OPIOID MISUSE |
Primary outcome
Feasibility of the intervention, defined as an enrollment rate of at least 60%
Time frame: 1 year
enrollment rate of at least 60% and retention rate of at least 75%
Acceptability of the intervention, measured by Client Satisfaction Questionnaire (CSQ-8) scores
Time frame: 1 year
Acceptability of the intervention, measured by CSQ-8 scores and patient reported feedback during exit interviews. On the CSQ-8, some items are reverse scored but higher scores mean greater satisfaction. Min value = 8, max value = 32
3 secondary outcomes
Depression, measured by the Patient Health Questionnaire (PHQ-9)
Time frame: 1 year
anxiety, as measured by the Generalized Anxiety Disorder questionnaire (GAD-7)
Time frame: 1 year
opioid misuse behaviors and consequences, as measured by the Current Opioid Misuse Measure (COMM)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Derived from this study: PubMed 39638585Yusufov M, Pirl WF, Greer JA, Mazzola E, Dalrymple KL, Tulsky JA, Braun IM, McHugh RK. Study protocol for a pilot randomised controlled trial of a virtually delivered behavioural intervention (ACTION) for adults with cancer at risk for opioid use disorder. BMJ Open. 2024 Dec 5;14(12):e096546. doi: 10.1136/bmjopen-2024-096546.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Miryam Yusufov, PhD principal investigator
Dana-Farber Cancer Institute
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 in people with Substance Use and Cancer, run by Dana-Farber Cancer Institute 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 4 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: finished, as of the sponsor's last update on 14 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of the intervention, defined as an enrollment rate of at least 60% (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05643027, which also lists 1 linked publication.
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 14 May 2026.