Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982058
• Other study ID #: 0220100274
• Secondary ID: 0220100274NCI-20
• Status: Completed
• Phase: N/A
• Start date: August 18, 2011
• Est. completion date: August 7, 2017

Study information

• Verified date: October 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: August 7, 2017
• Est. primary completion date: August 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Prostate Cancer
• Prostatic Neoplasms
• Sexual Dysfunction and Infertility
• Sexuality

Intervention

Other:
• communication intervention

• counseling intervention

• nutrition intervention

• questionnaire administration

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	The University Hospital	Newark	New Jersey
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Garden State Urology	Whippany	New Jersey

Sponsors (4)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Fox Chase Cancer Center, Memorial Sloan Kettering Cancer Center, Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological Functioning	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.	5 years
Primary	Relationship Functioning	Relationship satisfaction is assessed using the Dyadic Adjustment Scale	5 years
Secondary	Intimacy	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.	5 years
Secondary	Relationship Communication	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.	5 years