Ignite Creation Date:
2024-05-06 @ 1:34 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01842438
Status:
COMPLETED
Last Update Posted:
2017-06-05
First Post:
2013-04-24
Brief Title:
A Couple Support Intervention for Prostate Cancer
Sponsor:
University of Stirling
Organization:
University of Stirling
Study Overview
Official Title:
Psychosexual Support Following Prostate Cancer Surgery Feasibility and Outcomes of a Couple-based Intervention
Status:
COMPLETED
Status Verified Date:
2017-05
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:
Even with careful prostate surgery men find it difficult to have an erection Our previous research shows that couples are not often supported to cope with the effects of surgery on their sexual relationships In this study the investigators will design a way of supporting couples and test how well it works
The investigators will decide what the support should include eg duration frequency and timing of the support The investigators will do this by looking at available literature on the subject
The investigators will recruit 68 couples to the study half will receive standard care and the other half will be invited to attend six sessions of psychosexual support with specially trained professionals trained by men affected by prostate conditions and a cancercouple support specialist Before and after the support men and their partners will be asked to complete questionnaires which measure quality-of-life emotional needs and their relationship The investigators will ask the couples to fill out the questionnaires again six-months later to see if the support has long-term benefits At the end of the study the investigators will also interview 10 couples to find out their views of the support and another 10 couples about standard treatment
When the investigators have tested this support they expect to see men and their partners tell us that their quality of life has improved and they have higher satisfaction with their relationship The investigators will calculate the overall cost of providing this support and the benefits it has on reducing the need for other health-care services like General Practice use
The investigators will decide what the support should include eg duration frequency and timing of the support The investigators will do this by looking at available literature on the subject
The investigators will recruit 68 couples to the study half will receive standard care and the other half will be invited to attend six sessions of psychosexual support with specially trained professionals trained by men affected by prostate conditions and a cancercouple support specialist Before and after the support men and their partners will be asked to complete questionnaires which measure quality-of-life emotional needs and their relationship The investigators will ask the couples to fill out the questionnaires again six-months later to see if the support has long-term benefits At the end of the study the investigators will also interview 10 couples to find out their views of the support and another 10 couples about standard treatment
When the investigators have tested this support they expect to see men and their partners tell us that their quality of life has improved and they have higher satisfaction with their relationship The investigators will calculate the overall cost of providing this support and the benefits it has on reducing the need for other health-care services like General Practice use
Detailed Description:
Scientific abstract
Evidence shows significant unmet psychosexual needs for couples affected by prostate cancer Studies have identified the contribution that psychosocial interventions could have for couples eg strengthening healthy adaptation and better communication developing coping skills for distressed couples and facilitating healthy spousal communication to address the sexual rehabilitation needs
This is a feasibility study with a built-in pilot which will examine the acceptability feasibility and outcomes of a psychosexual intervention to support couples drawing on the Medical Research Council complex intervention framework
The intervention will be developed from the extant and our pilot work Men in outpatient surgical follow-up clinics will be screened using EPIC and recruited if scoring under the clinical threshold for potency 68 couples will be randomised to two arms one receiving six sessions of couple-support from specially trained counsellors and the others receiving standard care The primary outcome measure is health-related quality-of-life Pre post and 6-month follow-up outcomes will be measured in both individual quality of life anxietydepression and in relational terms relationship between couples An economic analysis will identify population costs
Evidence shows significant unmet psychosexual needs for couples affected by prostate cancer Studies have identified the contribution that psychosocial interventions could have for couples eg strengthening healthy adaptation and better communication developing coping skills for distressed couples and facilitating healthy spousal communication to address the sexual rehabilitation needs
This is a feasibility study with a built-in pilot which will examine the acceptability feasibility and outcomes of a psychosexual intervention to support couples drawing on the Medical Research Council complex intervention framework
The intervention will be developed from the extant and our pilot work Men in outpatient surgical follow-up clinics will be screened using EPIC and recruited if scoring under the clinical threshold for potency 68 couples will be randomised to two arms one receiving six sessions of couple-support from specially trained counsellors and the others receiving standard care The primary outcome measure is health-related quality-of-life Pre post and 6-month follow-up outcomes will be measured in both individual quality of life anxietydepression and in relational terms relationship between couples An economic analysis will identify population costs
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