Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01982058|
Recruitment Status : Active, not recruiting
First Posted : November 13, 2013
Last Update Posted : November 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Sexual Dysfunction and Infertility Sexuality||Other: communication intervention Other: counseling intervention Other: nutrition intervention Other: questionnaire administration||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||483 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer|
|Actual Study Start Date :||August 18, 2011|
|Actual Primary Completion Date :||August 7, 2017|
|Estimated Study Completion Date :||July 2018|
Experimental: 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.
|Other: communication intervention Other: counseling intervention Other: questionnaire administration|
Active Comparator: 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.
|Other: counseling intervention Other: nutrition intervention Other: questionnaire administration|
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).
|Other: questionnaire administration|
- Psychological Functioning [ Time Frame: 5 years ]General psychological functioning is assessed by the MHI-38 and the PHQ-9. Cancer-Specific distress is assessed by using the Impact of Events Scale Revised Cancer-Specific concerns is assessed with a 10 item assessment of commonly-experienced problems.
- Relationship Functioning [ Time Frame: 5 years ]Relationship satisfaction is assessed using the Dyadic Adjustment Scale
- Intimacy [ Time Frame: 5 years ]General Relationship Intimacy. The Personal Assessment of Intimacy in Relationships Intimacy scale (PAIR) (94) is a 6 item scale assessing emotional closeness. Cancer-specific Relationship Intimacy (95-96) Participants rate the degree to which they felt close to and emotionally intimate with their partner during discussions about the cancer experience.
- Relationship Communication [ Time Frame: 5 years ]
Perceived self-disclosure. The scale assesses the degree to which they disclose thoughts, information, and feelings about the cancer experience in the past week.
Perceived partner disclosure. The scale assesses the degree to which their partner disclosed thoughts, information, and feelings.
Perceived partner responsiveness. The scale assesses the degree to which the participant felt their partner understood and empathized with their disclosures.Mutual Constructive Communication. This subscale of the Communication Pattern Questionnaire (CPQ) is a 5-item scale that has been adapted.
Holding back. Participants rate the degree to which they held back from talking to their partner about 11 domains of concern.
Demand-Withdraw. The CPQ Demand-Withdraw subscale is a 6-item scale adapted.
Mutual Avoidance. The CPQ Mutual Avoidance subscale is an adapted 6-item scale.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982058
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|The University Hospital|
|Newark, New Jersey, United States, 07103|
|Garden State Urology|
|Whippany, New Jersey, United States, 07981|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10022|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Principal Investigator:||Sharon L Manne, Ph.D.||Rutgers Cancer Institute of New Jersey|