A Novel Intervention for Patients With Cancer

NCT05643027 | Recruiting

• 2 other identifiers: 21-5871K08CA259538-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 \& 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.

Conditions

Cancer; Psychological; Substance Use

Keywords

feasibility; acceptability

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Depression, measured by the Patient Health Questionnaire (PHQ-9)

  1 year

• anxiety, as measured by the Generalized Anxiety Disorder questionnaire (GAD-7)

  1 year

• opioid misuse behaviors and consequences, as measured by the Current Opioid Misuse Measure (COMM)

  1 year

Study Arms (1)

INTERVENTION FOR AVOIDANCE-RELATED OPIOID MISUSE

OTHER

Participants will participate in a six-session behavioral intervention, delivered by a licensed clinical psychologist.

Behavioral: Acceptance and Commitment Therapy

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

Six-session, skills-based behavioral intervention targeting risk factors for opioid use disorder in the context of cancer

INTERVENTION FOR AVOIDANCE-RELATED OPIOID MISUSE

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[ with 0 indicating that the patient is asymptomatic, 1 that the patient is symptomatic but fully ambulatory, and 2 that the patient is symptomatic and in bed \<50% of the day\]

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39638585 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Neoplasms

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Miryam Yusufov, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miryam Yusufov, PhD

CONTACT

(617) 582-7618; miryam_yusufov@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: December 8, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)