Acceptance-Based Treatment for Prostate Cancer Distress

Early Stage Prostate Cancer Clinical Trial

Official title:

Pilot Study of an Acceptance and Commitment Therapy Workshop for Distress and Decision Making in Early Stage Prostate Cancer in Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594593
• Other study ID #: 110353
• Status: Completed
• Phase: N/A
• First received: April 23, 2012
• Last updated: November 16, 2012
• Start date: March 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Veterans Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Early Stage Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Acceptance and Commitment Therapy
group-based behavioral workshop to address cancer-related distress

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation	Alliant International University, University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of dropouts	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.	6 months	No
Primary	Number of refusals	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.	6 months	No
Secondary	Hospital Anxiety and Depression Scale		baseline, post intervention, 2 weeks post intervention, 3 months post intervention	No
Secondary	Memorial Anxiety Scale for Prostate Cancer		baseline, post intervention, 2 weeks post intervention, 3 months post intervention	No