Acceptance and Commitment Therapy (ACT) - Based Treatment Development for Cancer Patients Treated for Pain

Completed

• Conditions: Cancer
• Interventions: Behavioral: Acceptance & Commitment Therapy

• Registration Number: NCT03910296
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

The purpose of this research study is to develop a psychological treatment for patients with cancer, focused on the psychological symptoms they experience during opioid therapy.

Detailed Description

This research study is a treatment development study, which is the first time investigators are developing this psychological intervention in patients with cancer, on opioid therapy. 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.

Study Timeline

• Study Start: 2019-02-20
• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-10
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• must be at least 18 years of age
• speak and comprehend English sufficiently to be able to complete the study procedures and participate in psychotherapy in English
• have been diagnosed with cancer
• have an estimated survival time ≥6 months (as approximated by palliative care clinic staff)
• score ≥4 on the Opioid Risk Tool (Webster & Webster, 2005) with psychosocial distress as one of the positive items.

Exclusion Criteria

• untreated bipolar disorder
• untreated psychotic disorders
• untreated borderline personality disorder
• have an estimated survival time ≤6 months (as approximated by clinic staff).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acceptance & Commitment Therapy	Acceptance & Commitment Therapy	* Acceptance \& Commitment Therapy (ACT) use acceptance, mindfulness, commitment, and behavior change strategies to increase psychological flexibility. * Each subject will participate for 6 sessions of Acceptance \& Commitment Therapy (ACT). * ACT trains patients to reframe their unpleasant, negative, private events while encouraging personal values.

Primary Outcome Measures

Name	Time	Method
Study feasibility	2 years	Defined by participants' completion of 80% of measures

Secondary Outcome Measures

Name	Time	Method
Intervention acceptability	2 years	Defined by participant responses on the semi-structured qualitative interviews, upon treatment completion.

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States