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Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

Primary Purpose

Prostate Cancer, Sexual Dysfunction and Infertility, Sexuality

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
communication intervention
counseling intervention
nutrition intervention
questionnaire administration
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Rutgers Cancer Institute of New Jersey
  • The University Hospital
  • Garden State Urology
  • Memorial Sloan-Kettering Cancer Center
  • Hospital of the University of Pennsylvania
  • Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Intimacy-Enhancing Couples

General Health and Wellness

Usual Care

Arm 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.

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.

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).

Outcomes

Primary Outcome Measures

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.
Relationship Functioning
Relationship satisfaction is assessed using the Dyadic Adjustment Scale

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 24, 2013
Last Updated
October 17, 2022
Sponsor
Rutgers, The State University of New Jersey
Collaborators
Rutgers Cancer Institute of New Jersey, Memorial Sloan Kettering Cancer Center, Fox Chase Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01982058
Brief Title
Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer
Official Title
Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 18, 2011 (Actual)
Primary Completion Date
August 7, 2017 (Actual)
Study Completion Date
August 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
Rutgers Cancer Institute of New Jersey, Memorial Sloan Kettering Cancer Center, Fox Chase Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Sexual Dysfunction and Infertility, Sexuality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
483 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intimacy-Enhancing Couples
Arm Type
Experimental
Arm 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.
Arm Title
General Health and Wellness
Arm Type
Active Comparator
Arm 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.
Arm Title
Usual Care
Arm Type
Other
Arm 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).
Intervention Type
Other
Intervention Name(s)
communication intervention
Intervention Type
Other
Intervention Name(s)
counseling intervention
Intervention Type
Other
Intervention Name(s)
nutrition intervention
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Primary Outcome Measure Information:
Title
Psychological Functioning
Description
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.
Time Frame
5 years
Title
Relationship Functioning
Description
Relationship satisfaction is assessed using the Dyadic Adjustment Scale
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Intimacy
Description
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.
Time Frame
5 years
Title
Relationship Communication
Description
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.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon L Manne, Ph.D.
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
The University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Garden State Urology
City
Whippany
State/Province
New Jersey
ZIP/Postal Code
07981
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

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