NCT00483678

Brief Summary

RATIONALE: A couples therapy program may enhance intimacy and reduce psychological distress in patients with prostate cancer and in their partners. PURPOSE: This randomized clinical trial is studying how well couples therapy enhances intimacy and reduces psychological distress in patients with advanced or recurrent prostate cancer and in their partners.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2007

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

10.9 years

First QC Date

June 6, 2007

Last Update Submit

March 5, 2018

Conditions

Prostate CancerPsychosocial Effects of Cancer and Its TreatmentSexual DysfunctionSexuality and Reproductive Issues

Keywords

psychosocial effects of cancer and its treatmentsexual dysfunctionsexuality and reproductive issuesrecurrent prostate cancerstage III prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (3)

  • Feasibility of Intimacy-Enhancing Couples Therapy (IECT) (e.g., eligibility rate, acceptance rate, attendance rate, satisfaction) assessed at baseline and at 1 month after completion of study intervention

    2 years

  • Comparison of the preliminary effect of IECT vs usual care on global psychological distress and relationship intimacy as assessed by the BSI-18 at baseline and at 1 month after completion of study intervention

    2 years

  • Relationship functioning, including intimacy, communication, and satisfaction (cancer-specific and overall) as assessed by the CRCS and A-DAS at baseline and at 1 month after completion of study intervention

    2 years

Study Arms (2)

Intimacy-Enhancing Couples Therapy

EXPERIMENTAL

Patients and their partners receive Intimacy-Enhancing Couples Therapy over 6 weeks comprising the following four 90-minute sessions: the Story of Cancer; Understanding the Couple, Ways of Relating and Key Influences; Intimacy; and Coping, Support, and Adaptation. Patients and their partners complete treatment satisfaction questionnaires after completion of study intervention.

Other: counseling interventionOther: questionnaire administrationProcedure: psychosocial assessment and care

standard psychosocial care

ACTIVE COMPARATOR

Patients and their partners receive standard psychosocial care. All participants complete questionnaires assessing psychological distress, intimacy, communication patterns, and overall relationship adjustment/satisfaction at baseline and at 1 month after completion of study intervention

Other: questionnaire administrationProcedure: psychosocial assessment and care

Interventions

counseling interventionOTHER
Intimacy-Enhancing Couples Therapy
questionnaire administrationOTHER
Intimacy-Enhancing Couples Therapystandard psychosocial care
psychosocial assessment and carePROCEDURE
Intimacy-Enhancing Couples Therapystandard psychosocial care

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of primary prostate cancer * Advanced or recurrent disease * Receiving concurrent hormonal therapy * Married and/or co-habitating with a partner for ≥ 1 year * T-score \> 50 on Brief Symptom Inventory-18 questionnaire (patient and/or partner) PATIENT CHARACTERISTICS: * Normal cognitive functioning * Able to speak and read English * No significant hearing impairment that would preclude study participation PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Fox Chase Cancer Center - Cheltenham

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsSexual Dysfunction, PhysiologicalSexuality

Interventions

CounselingPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesSexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesRehabilitationTherapeutics

Study Officials

  • Talia Zaider, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2007

First Posted

June 7, 2007

Study Start

April 1, 2007

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

US(2)