Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483678
Status:
COMPLETED
Last Update Posted:
2018-03-06
First Post:
2007-06-06
Brief Title:
Couples Therapy to Enhance Intimacy Between Patients With Advanced or Recurrent Prostate Cancer and Their Partners
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Pilot Study of an Intimacy-Enhancing Couples Therapy for Men With Advanced Prostate Cancer and Their Partners
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE A couples therapy program may enhance intimacy and reduce psychological distress in patients with prostate cancer and in their partners
PURPOSE This randomized clinical trial is studying how well couples therapy enhances intimacy and reduces psychological distress in patients with advanced or recurrent prostate cancer and in their partners
PURPOSE This randomized clinical trial is studying how well couples therapy enhances intimacy and reduces psychological distress in patients with advanced or recurrent prostate cancer and in their partners
Detailed Description:
OBJECTIVES
Determine the feasibility of Intimacy-Enhancing Couples Therapy IECT for patients with advanced or recurrent prostate cancer and their partners
Compare the effect of IECT vs usual care on patients and their partners level of global psychological distress
Compare the effect of IECT vs usual care on relationship intimacy in these participants
OUTLINE This is a randomized controlled pilot multicenter study Patients are stratified according to marital distress based on partners scores on the Abbreviated Dyadic Adjustment Scale high 21 vs low 21 Patients and their partners are randomized to 1 of 2 arms
Arm I Patients and their partners receive Intimacy-Enhancing Couples Therapy over 6 weeks comprising the following four 90-minute sessions the Story of Cancer Understanding the Couple Ways of Relating and Key Influences Intimacy and Coping Support and Adaptation Patients and their partners complete treatment satisfaction questionnaires after completion of study intervention
Arm II Patients and their partners receive standard psychosocial care All participants complete questionnaires assessing psychological distress intimacy communication patterns and overall relationship adjustmentsatisfaction at baseline and at 1 month after completion of study intervention
Determine the feasibility of Intimacy-Enhancing Couples Therapy IECT for patients with advanced or recurrent prostate cancer and their partners
Compare the effect of IECT vs usual care on patients and their partners level of global psychological distress
Compare the effect of IECT vs usual care on relationship intimacy in these participants
OUTLINE This is a randomized controlled pilot multicenter study Patients are stratified according to marital distress based on partners scores on the Abbreviated Dyadic Adjustment Scale high 21 vs low 21 Patients and their partners are randomized to 1 of 2 arms
Arm I Patients and their partners receive Intimacy-Enhancing Couples Therapy over 6 weeks comprising the following four 90-minute sessions the Story of Cancer Understanding the Couple Ways of Relating and Key Influences Intimacy and Coping Support and Adaptation Patients and their partners complete treatment satisfaction questionnaires after completion of study intervention
Arm II Patients and their partners receive standard psychosocial care All participants complete questionnaires assessing psychological distress intimacy communication patterns and overall relationship adjustmentsatisfaction at baseline and at 1 month after completion of study intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-07043 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |