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| ID | Type | Description | Link |
|---|---|---|---|
| 0220100274 | Other Identifier | IRB number | |
| NCI-2012-00552 | Other Identifier | CTRP (Clinical Trails Reporting Program) | |
| 131023 | Other Identifier | Rutgers Cancer Institute of New Jersey |
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| Name | Class |
|---|---|
| Rutgers Cancer Institute of New Jersey | OTHER |
| Memorial Sloan Kettering Cancer Center | OTHER |
| Fox Chase Cancer Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intimacy-Enhancing Couples | Experimental | 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. |
|
| General Health and Wellness | Active Comparator | 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. |
|
| Usual Care | Other | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| communication intervention | Other |
| ||
| counseling intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon L Manne, Ph.D. | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States | ||
| The University Hospital |
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| Other |
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| nutrition intervention | Other |
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| questionnaire administration | Other |
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| 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 |
| 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 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D012735 | Sexual Dysfunction, Physiological |
| D007246 | Infertility |
| D019529 | Sexuality |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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