A Novel Intervention for Patients With Cancer

Cancer Clinical Trial

Official title:

A Novel Intervention for Avoidance-Related Opioid Misuse in Patients With Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05643027
• Other study ID #: 21-587
• Secondary ID: 1K08CA259538-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 7, 2026

Study information

• Verified date: May 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 & 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: June 7, 2026
• Est. primary completion date: December 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Psychological
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• Acceptance and Commitment Therapy
Six-session, skills-based behavioral intervention targeting risk factors for opioid use disorder in the context of cancer

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and acceptability of the intervention, as reported on semi-structured exit interviews	exit interviews for qualitative feedback from research participants	1 year
Secondary	Feasibility and acceptability of the intervention, as reported on the client satisfaction questionnaire - 8 (CSQ-8)	patient-reported satisfaction on the CSQ-8; higher scores indicate higher levels of satisfaction but some items are reverse-scored	1 year