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NCT03910296 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03910296
Other study ID # 19-035
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 20, 2019
Est. completion date July 30, 2021

Study information
Verified date May 2022
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date July 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

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

Sponsors (1)
Lead Sponsor Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Study feasibility Defined by participants' completion of 80% of measures 2 years
Secondary Intervention acceptability Defined by participant responses on the semi-structured qualitative interviews, upon treatment completion. 2 years
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