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Acceptance-Based Treatment for Prostate Cancer Distress

This study has been completed.
Sponsor:
Collaborators:
Alliant International University
University of California, San Diego
Information provided by (Responsible Party):
Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT01594593
First received: April 23, 2012
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Early Stage Prostate Cancer
 Behavioral: Acceptance and Commitment Therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pilot Study of an Acceptance and Commitment Therapy Workshop for Distress and Decision Making in Early Stage Prostate Cancer in Veterans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Veterans Medical Research Foundation:

Primary Outcome Measures:
  • Number of dropouts [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, post intervention, 2 weeks post intervention, 3 months post intervention ] [ Designated as safety issue: No ]
  • Memorial Anxiety Scale for Prostate Cancer [ Time Frame: baseline, post intervention, 2 weeks post intervention, 3 months post intervention ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acceptance and Commitment Therapy
Group-based behavioral workshop to address cancer-related distress
 Behavioral: Acceptance and Commitment Therapy
group-based behavioral workshop to address cancer-related distress
No Intervention: treatment as usual

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594593

Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
Alliant International University
University of California, San Diego
Investigators
Principal Investigator: Niloofar Afari, PhD San Diego Veterans Healthcare System
  More Information

No publications provided

Responsible Party: Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01594593     History of Changes
Other Study ID Numbers: 110353
Study First Received: April 23, 2012
Last Updated: November 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Veterans Medical Research Foundation:
prostate cancer
behavioral
acceptance and commitment therapy
distress

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013