Helping African American Prostate Cancer Survivors and Their Partners Cope With Challenges After Surgery for Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00869739|
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : February 25, 2013
RATIONALE: Telephone counseling after radical prostatectomy may help African American prostate cancer survivors and their intimate partners cope with the problems and challenges of surgery, and may reduce distress and improve quality of life. It is not yet known which counseling and education program is more effective in helping prostate cancer survivors and their partners.
PURPOSE: This randomized clinical trial is studying effective ways to help African American prostate cancer survivors and their partners cope with challenges after surgery for early-stage prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Cancer Survivor Depression Gastrointestinal Complications Male Erectile Disorder Prostate Cancer Psychosocial Effects of Cancer and Its Treatment Urinary Complications||Behavioral: telephone-based intervention Other: educational intervention Other: partner-assisted coping skills training Other: questionnaire administration Procedure: psychosocial assessment and care Procedure: quality-of-life assessment||Not Applicable|
- To develop more effective ways to help both African American prostate cancer survivors and their intimate partners cope with the problems and challenges experienced after radical prostatectomy for prostate cancer.
- To evaluate the efficacy of a new, telephone-based, partner-assisted, coping skills training (CST) protocol for reducing survivor and partner disease-related and overall distress, addressing cancer-related strain and overall distress in survivors' intimate partners, and improving relationship quality between survivors and partners by enhancing intimacy and adjustment within the relationship.
- To identify for whom the intervention may be more or less efficacious by exploring the association between initial relationship functioning (i.e., dyadic adjustment scores reported by survivors and partners) and survivor outcomes and between initial relationship functioning and partner outcomes.
OUTLINE: Survivors are stratified according to symptom severity (low vs moderate vs high) and clinical risk category (low vs moderate vs high). Survivor/partner dyads are randomized to 1 of 3 intervention arms.
- Arm I (Partner-assisted coping skills training [PA-CST]): Survivor/partner dyads undergo a telephone-based, culturally sensitive PA-CST intervention in six weekly telephone sessions (60-minutes each) over 8 weeks, conducted by African American doctoral level clinical psychologists knowledgeable about prostate cancer and experienced in CST and cancer education. During these sessions, participants are trained in a variety of cognitive and behavioral skills to manage symptom-related distress and to improve their quality of life after prostate cancer treatment. Among these skills are strategies for communication (i.e., effective speaking and listening); behavioral coping methods (i.e., activity pacing, applied relaxation techniques, and goal setting to increase pleasant activities); and skills for managing negative mood and reducing emotional stress. Participants also receive guidance in working cooperatively with their partners to improve symptom management, including joint practicing of coping skills and problem-solving strategies.
- Arm II (Cancer education): Survivor/partner dyads undergo a telephone-based, culturally sensitive cancer education intervention in six weekly telephone sessions (60 minutes each) over 8 weeks, conducted by African American doctoral level clinical psychologists knowledgeable about prostate cancer and experienced in CST and cancer education. During the sessions, participants are educated about symptoms commonly experienced after prostatectomy (i.e., erectile dysfunction, urinary incontinence, nutrition, bowel problems, and fatigue) and medical treatment options for these symptoms. Participants also receive written materials about these information.
- Arm III (Wait-list control): Survivor/partner dyads receive usual care and are placed on a wait-list. After completing the study, survivors and their partners have the option of participating in either the CST or cancer education interventions.
All participants complete questionnaires at baseline, right after intervention (2 months), and 3 months after intervention (5 months). Survivors complete questionnaires over approximately 28 minutes to measure symptom distress/severity, depressed mood, quality of life, self-efficacy for symptom management, relationship quality, and coping strategies. Partners complete questionnaires over approximately 17 minutes to measure caregiver strain, depressed mood, partners' self-efficacy for symptom control, relationship quality, and coping strategies. At each evaluation, physicians provide ratings of illness severity, documentation of medical treatments for cancer and symptom management, and frequency of clinic visits for each survivor.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Prostate Cancer Recovery Enhancement for African American Men and Their Intimate Partners|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
- Symptom distress in survivors as assessed by the Sexual, Urinary, and Bowel Bother subscales of the Prostate Cancer Index Composite (EPIC) (16) at baseline, 2 months, and 5 months
- Depressed mood in survivors and partners as assessed by the depression subscale of the Profile of Mood States-SF (POMS-SF, 95) at baseline, 2 months, and 5 months
- Quality of life of survivors as assessed by the Physical Well-being, Functional Well-being, and Prostate Cancer subscales of FACT-P (127) at baseline, 2 months, and 5 months
- Caregiver strain in partners as assessed by the Caregiver Strain Index (CSI) at baseline, 2 months, and 5 months
- Self-efficacy for symptom control in survivors and partners as assessed by the Self-Efficacy for Symptom Control Inventory; EPIC; and CSI at baseline, 2 months, and 5 months
- Relationship functioning in survivors and partners as assessed by the Dyadic Adjustment Scale (129) and the Miller Social Intimacy Scale (130) at baseline, 2 months, and 5 months
- Coping skills in survivors and partners as assessed by the Coping Strategies, Social Problem Solving Scale-Revised, and La Trobe Communication Questionnaires at baseline, 2 months, and 5 months
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869739
|United States, North Carolina|
|Leo W. Jenkins Cancer Center at ECU Medical School|
|Greenville, North Carolina, United States, 27834|
|Principal Investigator:||Lisa C Campbell, PhD||East Carolina University|