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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Acceptance & Commitment 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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All potentially eligible patients will be identified through the DFCI ambulatory palliative care clinics.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: Acceptance & Commitment Therapy; ACT is a unique, third-wave therapy that uses metaphors and experiential exercises to encourage contact with previously avoided thoughts, feelings, and behaviors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study feasibility	Defined by participants' completion of 80% of measures	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention acceptability	Defined by participant responses on the semi-structured qualitative interviews, upon treatment completion.	2 years

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Miryam Yusufov, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Cancer
• Other Study ID Numbers: 19-035

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: [contact information for 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: BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No