Helping African American Prostate Cancer Survivors and Their Partners Cope With Challenges After Surgery for Prostate Cancer



Status:Recruiting
Conditions:Prostate Cancer, Cancer, Cancer, Depression, Erectile Dysfunction, Psychiatric, Gastrointestinal
Therapuetic Areas:Gastroenterology, Nephrology / Urology, Oncology, Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:August 2008

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Prostate Cancer Recovery Enhancement for African American Men and Their Intimate Partners


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.


OBJECTIVES:

Primary

- 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.

Secondary

- 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.

DISEASE CHARACTERISTICS:

- African American prostate cancer survivor

- Diagnosis of early-stage prostate cancer

- Stage T1-T3 disease

- No regional or metastatic prostate cancer

- Underwent radical prostatectomy as the primary treatment for prostate cancer
within the past 2 years

- Prior adjunctive radiotherapy secondary to surgery allowed

- No radiotherapy (i.e., external beam radiation or brachytherapy) as
primary form of treatment

- Intimate partner of cancer survivor

- Spouse or any cohabiting intimate partner identified by the survivor

- Same sex partners and partners of all ethnicities allowed

PATIENT CHARACTERISTICS:

- No dementia or unstable psychiatric condition

- No significant hearing impairment

- Fluent in English

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics
We found this trial at
1
site
600 Moye Boulevard
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
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