Ignite Creation Date:
2024-05-06 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03611517
Status:
UNKNOWN
Last Update Posted:
2020-02-24
First Post:
2018-05-29
Brief Title:
Sexual Rehabilitation Programme After Radiotherapy for Gynaecological Cancer
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
SPARC Study A Nurse-led Sexual Rehabilitation Programme for Women With Gynaecological Cancers Receiving Radiotherapy a Randomized Multicentre Trial
Status:
UNKNOWN
Status Verified Date:
2020-02
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:
SPARC
Brief Summary:
The aim of this randomized controlled trial is to demonstrate that a nurse-led sexual rehabilitation intervention significantly improves sexual recovery and functioning among gynaecological cancer GC patients treated with radiotherapy RT compared with usual care ie oral information by a nurse or doctor and written information
Women with GC n220 who receive RT in one of the participating Dutch GC centres n9 will be randomized to either the sexual rehabilitation intervention n 110 or usual care n 110 stratified for combined RTBT vs RT alone and for having a partner yesno Women are eligible for participation if they have been diagnosed with either cervical endometrial or vaginal cancer are treated with radiotherapy are 18 years or older and wish to retain their sexual activity on the short or long term
The intervention consists of four one-hour sessions at 1 month 3 6 and 12 months after RT Women who received RTBT will receive an additional appointment with the nurse 2 months after RTBT to promote regular use of vaginal dilators in order to prevent stenosis Participants are requested to complete questionnaires at baseline and at 1 3 6 and 12 months post-RT
The primary endpoint is sexual functioning at 12 months Secondary endpoints include vaginal symptoms and body concerns fear of coital and non-coital sexual activity sexual distress treatment-related distress generic health-related quality of life psychological distress and relationship dissatisfaction
Hypothesis The investigators expect women who receive the nurse-led sexual rehabilitation programme to report a greater improvement in sexual functioning from immediate post-radiotherapy to 1 year post-radiotherapy than women in the control group
Women with GC n220 who receive RT in one of the participating Dutch GC centres n9 will be randomized to either the sexual rehabilitation intervention n 110 or usual care n 110 stratified for combined RTBT vs RT alone and for having a partner yesno Women are eligible for participation if they have been diagnosed with either cervical endometrial or vaginal cancer are treated with radiotherapy are 18 years or older and wish to retain their sexual activity on the short or long term
The intervention consists of four one-hour sessions at 1 month 3 6 and 12 months after RT Women who received RTBT will receive an additional appointment with the nurse 2 months after RTBT to promote regular use of vaginal dilators in order to prevent stenosis Participants are requested to complete questionnaires at baseline and at 1 3 6 and 12 months post-RT
The primary endpoint is sexual functioning at 12 months Secondary endpoints include vaginal symptoms and body concerns fear of coital and non-coital sexual activity sexual distress treatment-related distress generic health-related quality of life psychological distress and relationship dissatisfaction
Hypothesis The investigators expect women who receive the nurse-led sexual rehabilitation programme to report a greater improvement in sexual functioning from immediate post-radiotherapy to 1 year post-radiotherapy than women in the control group
Detailed Description:
The primary objective of this randomized controlled trial is to evaluate if the nurse-led sexual rehabilitation intervention improves sexual recovery and functioning in patients with gynaecological cancers GC who are treated with either external pelvic radiotherapy only ie RT or external pelvic radiotherapy combined with brachytherapy ie RTBT compared with usual care Q1
The secondary objective is to evaluate if the nurse-led sexual rehabilitation program decreases vaginal symptoms and body image concerns fear of non-coital sexual activity treatment-related distress psychological and sexual distress and vaginal physical symptoms assessed during physical examination by the radiation oncologist and improvesincreases generic-related health related quality of life related to gynaecological cancer relationship satisfaction and frequency of dilator use Q2 to evaluate the cost-effectiveness of the intervention Q3 and to evaluate whether an improvement in sexual functioning is moderated by treatment characteristics and pre-treatment patient characteristics such as age or sexual functioning and mediated by reduction of vaginal symptoms and by regular use of dilators in women treated with RTBT Q4
The secondary objective is to evaluate if the nurse-led sexual rehabilitation program decreases vaginal symptoms and body image concerns fear of non-coital sexual activity treatment-related distress psychological and sexual distress and vaginal physical symptoms assessed during physical examination by the radiation oncologist and improvesincreases generic-related health related quality of life related to gynaecological cancer relationship satisfaction and frequency of dilator use Q2 to evaluate the cost-effectiveness of the intervention Q3 and to evaluate whether an improvement in sexual functioning is moderated by treatment characteristics and pre-treatment patient characteristics such as age or sexual functioning and mediated by reduction of vaginal symptoms and by regular use of dilators in women treated with RTBT Q4
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 10674 | OTHER_GRANT | None | None |
| NL6276705817 | OTHER | CCMO | None |