Coping in African American Prostate Cancer Survivors (CAAPS)
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|ClinicalTrials.gov Identifier: NCT00589966|
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : March 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Behavioral: Coping Skills Training Behavioral: Prostate Cancer Education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Coping Skills Training Groups to Enhance Recovery From Prostate Cancer in African American Men|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
|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.
- Symptom distress [ Time Frame: pretreatment, posttreatment, 3 mo followup ]
- Emotional functioning [ Time Frame: pretreatment, posttreatment, 3 mo followup ]
- Physical functioning [ Time Frame: pretreatment, posttreatment, 3 mo followup ]
- Self-efficacy for symptom management [ Time Frame: pretreatment, posttreatment, 3 mo followup ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589966
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27704|
|Principal Investigator:||Francis J Keefe, Ph.D.||Duke University|
|Study Director:||Lisa C Campbell, Ph.D.||Duke University|