Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

483 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-18

Study Completion Date

2017-08-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Participating in a therapy program may enhance communication and intimacy between men with prostate cancer and their partners.

PURPOSE: This randomized clinical trial is studying how well therapy enhances communication and intimacy for men with early stage prostate cancer and for their partners.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners

NCT00503646

Prostate Cancer Psychosocial Effects of Cancer and Its Treatment Sexual Dysfunction and Infertility +1 more

UNKNOWN NA

Goals of Sexual Function in Prostate Cancer Survivors and Their Partners After Cancer Treatment

NCT01018901

Prostate Cancer

COMPLETED NA

Assessment of Primary Androgen Deprivation Therapy for Non-metastatic Prostate Cancer Among Elderly

NCT00161252

Prostate Cancer

WITHDRAWN

Supportive Therapy in Androgen Deprivation Clinic in Improving Health Outcomes and Managing Side Effects in Patients With Prostate Cancer

NCT02168062

Prostate Adenocarcinoma

TERMINATED PHASE2

Intensive Diet and Exercise or Standard of Care in Improving Physical Function and Quality of Life in Patients With Prostate Cancer Undergoing Androgen Deprivation Therapy

NCT02050906

Recurrent Prostate Cancer Stage IV Prostate Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Aim 1 A. To evaluate the impact of an Intimacy-Enhancing Couples' intervention (IEC) versus a General Health and Wellness Intervention (GHW) and a Usual care control (UC) on patient and partner psychological and relationship outcomes.

B. To determine whether relationship length, pre-intervention relationship satisfaction, and men's pre-intervention masculinity moderate the effects of IEC on couples' psychological and relationship outcomes

Aim 2 A. To evaluate whether IEC has an effect on couples' communication and intimacy when compared with GHW and UC and to determine whether changes in relationship communication and intimacy mediate changes in couples' psychological and relationship outcomes.

Exploratory Aim:

A. To evaluate the impact of IEC versus GHW on physical activity and fruit and vegetable intake as well as each partner's support for the other partner's adoption of greater physical activity and more fruit and vegetable intake.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer Sexual Dysfunction and Infertility Sexuality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intimacy-Enhancing Couples

Patients and their partners receive communication and intimacy-enhancing intervention (IEC) once a week comprising the following five 90-minute sessions: Orientation and Stories of the Cancer Experience; Communication and Listening to Partner's concerns; Communication and Coping with Cancer Issues as a Team; Being Supportive to Solve Concerns; and Reflecting on Changes and Future Adaptation.

Group Type EXPERIMENTAL

communication intervention

Intervention Type OTHER

counseling intervention

Intervention Type OTHER

questionnaire administration

Intervention Type OTHER

General Health and Wellness

Patients and their partners receive a General Health and Wellness intervention focusing on nutrition and physical activity once a week comprising of five 90-minute sessions: Introduction and Nutrition Basics; Nutrition and Prevention of Recurrence; Nutritional Review and Introduction to Relaxation; Physical Activity Basics; Aerobics and Resistance Exercises and Wrap up.

Group Type ACTIVE_COMPARATOR

counseling intervention

Intervention Type OTHER

nutrition intervention

Intervention Type OTHER

questionnaire administration

Intervention Type OTHER

Usual Care

Patients and their partners receive standard psychological and emotional care (usual care \[UC\]) (i.e., social work consultations and referral to a psychiatrist or psychologist, if requested or deemed necessary by the attending physician).

Group Type OTHER

questionnaire administration

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

communication intervention

Intervention Type OTHER

counseling intervention

Intervention Type OTHER

nutrition intervention

Intervention Type OTHER

questionnaire administration

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient has a primary diagnosis of localized prostate cancer (T1, T2, N=0 M=0, T3 N=0 M=0)
* Patient had surgery or initiated radiation treatment (brachytherapy or external beam radiation) or began pre-radiation Androgen deprivation therapy within the past 12 months.
* Patient is currently married or living with a partner, with relationship duration at least 1 year
* Patient and partner live within a 1 hour commuting distance to recruitment site
* Patient and partner read and speak English
* Patient has an Impact of Events Scale (IES) score greater than or equal to 16 and/or partner has an IES score greater than or equal to 17.

Exclusion Criteria

* Patient had a previous definitive treatment for prostate cancer
* Patient has a concurrent diagnosis of another cancer (other than non-melanoma skin cancer)
* Partner is diagnosed with cancer (other than non-melanoma skin cancer)
* Patient or partner have a significant hearing impairment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes