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Completed

NCT Number: NCT01982058

Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Infertility Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Sexual Behavior Sexual Dysfunction and Infertility Sexual Dysfunction, Physiological Sexuality Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Communication intervention

Other

counseling intervention

Other

Nutrition Intervention

Other

Questionnaire Administration

Other

Primary outcomes

  1. 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.

  2. Relationship Functioning

    Time frame: 5 years

    Relationship satisfaction is assessed using the Dyadic Adjustment Scale

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Fox Chase Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Rutgers Cancer Institute of New Jersey

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Nov 13, 2013
Registry last updated
Oct 19, 2022

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.

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