A Novel Intervention for Patients With Cancer (ACTION)

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:

• 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.

Study Overview

• Status: Completed
• Conditions: Cancer; Substance Use; Psychological
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy

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:

1. determine whether this intervention will be appropriate for further testing;
2. identify which parts of the protocol and procedures need to be modified; and
3. 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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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]

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: INTERVENTION FOR AVOIDANCE-RELATED OPIOID MISUSE; Participants will participate in a six-session behavioral intervention, delivered by a licensed clinical psychologist.	Behavioral: Acceptance and Commitment Therapy; Six-session, skills-based behavioral intervention targeting risk factors for opioid use disorder in the context of cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	1 year

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Miryam Yusufov, PhD, Dana-Farber Cancer Institute

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): May 11, 2026
• Study Completion (Actual): May 11, 2026

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: feasibility; acceptability
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Neoplasms; Substance-Related Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy
• Other Study ID Numbers: 21-587; 1K08CA259538-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No