Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

Rutgers The State University of New Jersey

Status: Completed

Conditions: Sexuality; Sexual Dysfunction and Infertility; Prostate Cancer

Treatments: Other: nutrition intervention; Other: communication intervention; Other: questionnaire administration; Other: counseling intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01982058

NCI-2012-00552 (Other Identifier)

131023 (Other Identifier)

0220100274 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 483 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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483 participants in 3 patient groups

Intimacy-Enhancing Couples

Experimental group

Description:

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.

Treatment:

Other: questionnaire administration

Other: communication intervention

Other: counseling intervention

General Health and Wellness

Active Comparator group

Description:

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.

Treatment:

Other: nutrition intervention

Other: questionnaire administration

Other: counseling intervention

Usual Care

Other group

Description:

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).

Treatment:

Other: questionnaire administration