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

NCT ID: NCT00869739

Last Updated: 2013-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2012-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Cancer Survivor; Depression; Gastrointestinal Complications; Male Erectile Disorder; Prostate Cancer; Psychosocial Effects of Cancer and Its Treatment; Urinary Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Interventions

telephone-based intervention

Intervention Type: BEHAVIORAL

educational intervention

Intervention Type: OTHER

partner-assisted coping skills training

Intervention Type: OTHER

questionnaire administration

Intervention Type: OTHER

psychosocial assessment and care

Intervention Type: PROCEDURE

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

East Carolina University

OTHER

Sponsor Role: lead

Responsible Party

Lisa Campbell

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa C Campbell, PhD

Role: PRINCIPAL_INVESTIGATOR

East Carolina University

Locations

Leo W. Jenkins Cancer Center at ECU Medical School

Greenville, North Carolina, United States

Countries

United States

Other Identifiers

R01CA122704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ECU-08-0485

Identifier Type: -

Identifier Source: secondary_id

CDR0000634536

Identifier Type: -

Identifier Source: org_study_id