Back to resultsAcceptance-Based Treatment for Prostate Cancer Distress
Primary Purpose
Early Stage Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Early Stage Prostate Cancer focused on measuring prostate cancer, behavioral, acceptance and commitment therapy, distress
Eligibility Criteria
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
Sites / Locations
- VA San Diego Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acceptance and Commitment Therapy
treatment as usual
Arm Description
Group-based behavioral workshop to address cancer-related distress
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Hospital Anxiety and Depression Scale
Memorial Anxiety Scale for Prostate Cancer
Full Information
NCT ID
NCT01594593
First Posted
April 23, 2012
Last Updated
November 16, 2012
Sponsor
Veterans Medical Research Foundation
Collaborators
Alliant International University, University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT01594593
Brief Title
Acceptance-Based Treatment for Prostate Cancer Distress
Official Title
Pilot Study of an Acceptance and Commitment Therapy Workshop for Distress and Decision Making in Early Stage Prostate Cancer in Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veterans Medical Research Foundation
Collaborators
Alliant International University, University of California, San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage Prostate Cancer
Keywords
prostate cancer, behavioral, acceptance and commitment therapy, distress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acceptance and Commitment Therapy
Arm Type
Experimental
Arm Description
Group-based behavioral workshop to address cancer-related distress
Arm Title
treatment as usual
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
group-based behavioral workshop to address cancer-related distress
Primary Outcome Measure Information:
Title
Number of dropouts
Description
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.
Time Frame
6 months
Title
Number of refusals
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Time Frame
baseline, post intervention, 2 weeks post intervention, 3 months post intervention
Title
Memorial Anxiety Scale for Prostate Cancer
Time Frame
baseline, post intervention, 2 weeks post intervention, 3 months post intervention
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niloofar Afari, PhD
Organizational Affiliation
San Diego Veterans Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acceptance-Based Treatment for Prostate Cancer Distress
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