Acceptance-Based Treatment for Prostate Cancer Distress

Not Applicable

Completed

• Conditions: Early Stage Prostate Cancer
• Interventions: Behavioral: Acceptance and Commitment Therapy

• Registration Number: NCT01594593
• Lead Sponsor: Veterans Medical Research Foundation

Brief Summary

Prostate cancer (PCa) is the most common type of cancer in men and the second leading cause of death in American men. Those diagnosed with localized prostate cancer encounter three sources of psychological distress: 1) diagnosis itself, 2) treatment decision making, and 3) the often life-altering side effects of treatment. In addition, patients who choose to undergo active surveillance which focuses on monitoring cancer in lieu of treatment, experience distress related to living with cancer. Acceptance and Commitment Therapy (ACT) is an established psychosocial intervention that has been used extensively for mental health treatment and has shown benefits for various chronic conditions. ACT is a behavioral intervention that focuses on tolerating distress and improving function. This pilot study is designed to test the feasibility of ACT for distress reduction and improved quality of life in patients recently diagnosed with early-stage, localized PCa.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-09
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-16
• Last Update Posted: 2012-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Localized prostate cancer in Stages I or II
• Ability to give informed consent
• Age 18 to 80 years old
• Willingness to come in for a day long intervention

Exclusion Criteria

• Acute psychosis
• Suicidal ideation
• Homicidal ideation
• Active substance abuse
• Dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acceptance and Commitment Therapy	Acceptance and Commitment Therapy	Group-based behavioral workshop to address cancer-related distress

Primary Outcome Measures

Name	Time	Method
Number of dropouts	6 months	Because this is a pilot study to determine feasibility, one of the primary outcomes is the number of participants who drop out of the active treatment arm.
Number of refusals	6 months	Because this is a pilot study to determine feasibility, one of the primary outcomes is the number of participants who refuse the active treatment arm.

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale	baseline, post intervention, 2 weeks post intervention, 3 months post intervention
Memorial Anxiety Scale for Prostate Cancer	baseline, post intervention, 2 weeks post intervention, 3 months post intervention

Trial Locations

Locations (1)

VA San Diego Healthcare System; 🇺🇸 San Diego, California, United States