Clinical trial NCT00589966: Coping in African American Prostate Cancer Survivors
Official title: Coping Skills Training Groups to Enhance Recovery From Prostate Cancer in African American Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer treatment
treatment side-effects
early diagnosis
African American Men
coping skills training
quality of life
Prostate cancer treatment side-effects
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2008-01-10
Enrollment: 62
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
measure: Symptom distress
timeFrame: pretreatment, posttreatment, 3 mo followup
Secondary outcomes:
measure: Emotional functioning
timeFrame: pretreatment, posttreatment, 3 mo followup
measure: Physical functioning
timeFrame: pretreatment, posttreatment, 3 mo followup
measure: Self-efficacy for symptom management
timeFrame: pretreatment, posttreatment, 3 mo followup
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Francis J Keefe, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Lisa C Campbell, Ph.D.
role: STUDY_DIRECTOR
References: