A Novel Intervention for Patients With Cancer

NCT ID: NCT05643027

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2026-07-01

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.

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

Conditions

Substance Use; Cancer; Psychological

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

INTERVENTION FOR AVOIDANCE-RELATED OPIOID MISUSE

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

Group Type: OTHER

Acceptance and Commitment Therapy

Intervention Type: BEHAVIORAL

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

Interventions

Acceptance and Commitment Therapy

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Miryam Yusufov, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miryam Yusufov, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Miryam Yusufov, PhD

Role: CONTACT

miryam_yusufov@dfci.harvard.edu

(617) 582-7618

Facility Contacts

Miryam Yusufov, PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 39638585 (View on PubMed)

Other Identifiers

1K08CA259538-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-587

Identifier Type: -

Identifier Source: org_study_id