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

Not Enrolling
Cancer Survivor, Depression, Gastrointestinal Complications, Male Erectile Disorder, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Urinary Complications

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Trial Information

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



- 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.

Inclusion Criteria


- 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


- No dementia or unstable psychiatric condition

- No significant hearing impairment

- Fluent in English


- See Disease Characteristics

Type of Study:


Study Design:

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

Outcome Measure:

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

Safety Issue:


Principal Investigator

Lisa C Campbell, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

East Carolina University


United States: Institutional Review Board

Study ID:




Start Date:

August 2008

Completion Date:

July 2012

Related Keywords:

  • Cancer Survivor
  • Depression
  • Gastrointestinal Complications
  • Male Erectile Disorder
  • Prostate Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Urinary Complications
  • cancer survivor
  • depression
  • psychosocial effects of cancer and its treatment
  • male erectile disorder
  • urinary complications
  • gastrointestinal complications
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Depression
  • Depressive Disorder
  • Prostatic Neoplasms
  • Erectile Dysfunction



Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenville, North Carolina  27834