Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503646
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2007-07-17
Brief Title:
Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Communication and Intimacy-Enhancing Intervention for Men Diagnosed With Early Stage Prostate Cancer and Their Partners A Pilot and Feasibility Trial
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
RECRUITING
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 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
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:
OBJECTIVES
Primary
To evaluate the feasibility and acceptability of conducting a randomized clinical trial evaluating communication and intimacy-enhancing intervention CI vs usual care UC
To collect descriptive information and basic psychometrics on proposed study measures
To gather preliminary data regarding the impact of CI on couples psychosocial adaptation relationship closeness and sexual intimacy in order to calculate power for a larger full scale trial
OUTLINE This is a multicenter study Patients and their partners are randomized to 1 of 2 intervention arms
Arm I Patients and their partners receive communication and intimacy-enhancing intervention CI once a week comprising the following five 90-minute sessions Rationale and Overview Basic Communication Intimacy and Sexuality Improving Intimacy and Reflecting on Changes and Cancer Survivorship
Arm II Patients and their partners receive standard psychological and emotional care usual care UC ie social work consultations and referral to a psychiatrist or psychologist if requested or deemed necessary by the attending physician
Physical impairment psychological adjustment relationship closeness relationship communication sexual function and satisfaction male self-esteem relationship satisfaction intervention evaluation and erectile dysfunction treatment utilization and referral are assessed at 1 week post-intervention or at 6-8 weeks post baseline and then at 3 months for patients and their partners in arm I and at 8 weeks post-baseline and then at 3 months for patients and their partners in arm II
PROJECTED ACCRUAL A total of 50 patients and 50 partners will be accrued for this study
Primary
To evaluate the feasibility and acceptability of conducting a randomized clinical trial evaluating communication and intimacy-enhancing intervention CI vs usual care UC
To collect descriptive information and basic psychometrics on proposed study measures
To gather preliminary data regarding the impact of CI on couples psychosocial adaptation relationship closeness and sexual intimacy in order to calculate power for a larger full scale trial
OUTLINE This is a multicenter study Patients and their partners are randomized to 1 of 2 intervention arms
Arm I Patients and their partners receive communication and intimacy-enhancing intervention CI once a week comprising the following five 90-minute sessions Rationale and Overview Basic Communication Intimacy and Sexuality Improving Intimacy and Reflecting on Changes and Cancer Survivorship
Arm II Patients and their partners receive standard psychological and emotional care usual care UC ie social work consultations and referral to a psychiatrist or psychologist if requested or deemed necessary by the attending physician
Physical impairment psychological adjustment relationship closeness relationship communication sexual function and satisfaction male self-esteem relationship satisfaction intervention evaluation and erectile dysfunction treatment utilization and referral are assessed at 1 week post-intervention or at 6-8 weeks post baseline and then at 3 months for patients and their partners in arm I and at 8 weeks post-baseline and then at 3 months for patients and their partners in arm II
PROJECTED ACCRUAL A total of 50 patients and 50 partners will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-07069 | None | None | None |