Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer
3 other identifiers
interventional
483
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Aug 2011
Longer than P75 for not_applicable prostate-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 18, 2011
CompletedFirst Submitted
Initial submission to the registry
June 24, 2013
CompletedFirst Posted
Study publicly available on registry
November 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2017
CompletedOctober 19, 2022
October 1, 2022
6 years
June 24, 2013
October 17, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Relationship Functioning
Relationship satisfaction is assessed using the Dyadic Adjustment Scale
5 years
Secondary Outcomes (2)
Intimacy
5 years
Relationship Communication
5 years
Study Arms (3)
Intimacy-Enhancing Couples
EXPERIMENTALPatients 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.
General Health and Wellness
ACTIVE COMPARATORPatients 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.
Usual Care
OTHERPatients 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rutgers, The State University of New Jerseylead
- Rutgers Cancer Institute of New Jerseycollaborator
- Memorial Sloan Kettering Cancer Centercollaborator
- Fox Chase Cancer Centercollaborator
Study Sites (6)
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
The University Hospital
Newark, New Jersey, 07103, United States
Garden State Urology
Whippany, New Jersey, 07981, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10022, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon L Manne, Ph.D.
Rutgers Cancer Institute of New Jersey
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
June 24, 2013
First Posted
November 13, 2013
Study Start
August 18, 2011
Primary Completion
August 7, 2017
Study Completion
August 7, 2017
Last Updated
October 19, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share