NCT Number: NCT00483678
Couples Therapy to Enhance Intimacy Between Patients With Advanced or Recurrent Prostate Cancer and Their Partners
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–120 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Memorial Sloan Kettering Cancer Center, New York, United States
About this study
OBJECTIVES:
- Determine the feasibility of Intimacy-Enhancing Couples Therapy (IECT) for patients with advanced or recurrent prostate cancer and their partners.
- Compare the effect of IECT vs usual care on patients' and their partners' level of global psychological distress.
- Compare the effect of IECT vs usual care on relationship intimacy in these participants.
OUTLINE: This is a randomized, controlled, pilot, multicenter study. Patients are stratified according to marital distress based on partners' scores on the Abbreviated Dyadic Adjustment Scale (high [< 21] vs low [≥ 21]). Patients and their partners are randomized to 1 of 2 arms.
- Arm I: 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.
- Arm II: 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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Questionnaire Administration
Otherpsychosocial assessment and care
ProcedurePrimary outcomes
-
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
Time frame: 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
Time frame: 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
Time frame: 2 years
Sponsors and collaborators
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Collaborators
- Fox Chase Cancer Center
- National Cancer Institute (NCI)
Registry information
Official study title
A Pilot Study of an Intimacy-Enhancing Couples Therapy for Men With Advanced Prostate Cancer and Their Partners
Important dates
- Study start
- 2007
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Jun 7, 2007
- Registry last updated
- Mar 6, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
NCT00057759
Behavior, Genital Diseases
Concord, California, United States
View Trial DetailsIntensity-Modulated Radiation Therapy With or Without Decreased Radiation Dose to Erectile Tissue in Treating Patients With Stage II Prostate Cancer
NCT00084552
Behavior, Genital Diseases
Philadelphia, Pennsylvania, United States
View Trial DetailsRadiation Therapy in Treating Patients With Prostate Cancer
NCT01434290
Genital Diseases, Genital Diseases, Male
Birmingham, Alabama, United States
View Trial DetailsPelvic Floor Muscle Training and Biofeedback or Standard Therapy in Men Who Have Undergone Radical Prostatectomy or Transurethral Resection of the Prostate
NCT00632138
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Ashton-under-Lyne, England, United Kingdom
View Trial Details