Coping in African American Prostate Cancer Survivors (CAAPS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00589966
First received: December 31, 2007
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

This study will test the effectiveness of an 8-week group intervention for African American men who have been treated for prostate cancer. The group intervention is based on 1) the cognitive-behavioral theoretical approach to improving adjustment to cancer and 2) masculinity theory as it relates to coping strengths and preferences in men. We will test the effectiveness of this coping skills intervention for improving survivors' quality of life in 4 areas: 1) distress related to sexual, urinary, and bowel symptoms; 2) self-confidence for managing symptoms; 3) overall emotional functioning; and 4) overall physical functioning. The effect of the coping skills group intervention in these 4 areas will be compared to a comparison intervention in which African American men will receive basic education about prostate cancer, but will not participate in coping skills training.


Condition Intervention
Prostate Cancer
Behavioral: Coping Skills Training
Behavioral: Prostate Cancer Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Coping Skills Training Groups to Enhance Recovery From Prostate Cancer in African American Men

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Symptom distress [ Time Frame: pretreatment, posttreatment, 3 mo followup ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Emotional functioning [ Time Frame: pretreatment, posttreatment, 3 mo followup ] [ Designated as safety issue: No ]
  • Physical functioning [ Time Frame: pretreatment, posttreatment, 3 mo followup ] [ Designated as safety issue: No ]
  • Self-efficacy for symptom management [ Time Frame: pretreatment, posttreatment, 3 mo followup ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: May 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coping Skills Training Behavioral: Coping Skills Training
Coping Skills Training teaches skills for managing physical, emotional, and social challenges of symptoms commonly experienced by men who have undergone treatment for early stage prostate cancer. Coping skills include activity pacing, managing negative mood, communication enhancement, and applied relaxation.
Active Comparator: Prostate Cancer Education Behavioral: Prostate Cancer Education
Prostate Cancer Education provides information on the following topics: common treatment side-effects, medical options for symptom management, nutrition to support recovery, and guidelines for communicating with your healthcare team.

Detailed Description:

African American men have higher diagnosis and death rates from prostate cancer than any other ethnic group. After treatment for prostate cancer, African American men also report slower recovery, including physical symptoms (e.g., sexual dysfunction, urinary incontinence) that can persist well beyond the immediate post-treatment period. Despite the evidence that African American men have poorer outcomes following prostate cancer treatment, very little is known about how to improve quality of life and enhance recovery in this group of survivors.

This study will test the effectiveness of an 8-week group intervention for African American men who have been treated for prostate cancer. The group intervention is based on 1) the cognitive-behavioral theoretical approach to improving adjustment to cancer and 2) masculinity theory as it relates to coping strengths and preferences in men. In this group intervention African American prostate cancer survivors will be taught a variety of coping skills for managing both the physical and emotional challenges of living with prostate cancer. The coping skills training groups will consist of 6-8 survivors and will be conducted in both medical center clinic settings and community settings (e.g., churches). Each group session will be co-led by an African American psychologist and an African American male lay person. We will test the effectiveness of this coping skills intervention for improving survivors' quality of life in 4 areas: 1) distress related to sexual, urinary, and bowel symptoms; 2) self-confidence for managing symptoms; 3) overall emotional functioning; and 4) overall physical functioning. The effect of the coping skills group intervention in these 4 areas will be compared to a comparison intervention in which African American men will receive basic education about prostate cancer, but will not participate in coping skills training. The recruitment goal for this project is 154 African American men treated for early stage prostate cancer.

Due to the comprehensive nature of the coping skills training intervention (i.e., a variety of coping skills targeting both physical and emotional challenges of prostate cancer), we expect coping skills training to be significantly more effective than cancer education. Ultimately, findings from this study could fill a significant gap that exists in the research literature regarding our understanding of how to help African American men achieve the fullest possible recovery following prostate cancer treatment.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of early stage, localized prostate cancer (T1-T3)
  • Must have received treatment within previous 2 years
  • Capable of self-care per Karnofsky Performance Status score of 60+
  • African American
  • Must have physician who can confirm treatment history

Exclusion Criteria:

  • Undergoing primary treatment 2 or more years ago
  • Having regional or metastatic prostate cancer at time of screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589966

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27704
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Francis J Keefe, Ph.D. Duke University
Study Director: Lisa C Campbell, Ph.D. Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00589966     History of Changes
Other Study ID Numbers: Pro00000351, W81XWH-07-0091
Study First Received: December 31, 2007
Last Updated: February 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
prostate cancer treatment
treatment side-effects
early diagnosis
African American Men
coping skills training
quality of life
Prostate cancer treatment side-effects

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 July 24, 2014