Coping in African American Prostate Cancer Survivors

Prostate Cancer Clinical Trial

— CAAPS  

Official title:

Coping Skills Training Groups to Enhance Recovery From Prostate Cancer in African American Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00589966
• Other study ID #: Pro00000351
• Secondary ID: W81XWH-07-0091
• Status: Completed
• Phase: N/A
• First received: December 31, 2007
• Last updated: February 28, 2013
• Start date: May 2007
• Est. completion date: April 2010

Study information

• Verified date: February 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom distress		pretreatment, posttreatment, 3 mo followup	No
Secondary	Emotional functioning		pretreatment, posttreatment, 3 mo followup	No
Secondary	Physical functioning		pretreatment, posttreatment, 3 mo followup	No
Secondary	Self-efficacy for symptom management		pretreatment, posttreatment, 3 mo followup	No