Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04544735
Status:
SUSPENDED
Last Update Posted:
2023-10-26
First Post:
2020-09-04
Brief Title:
Improving Womens Function After Pelvic Radiation
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Integrated Physical Therapy and Coping Skills Training for Improving Womens Sexual Function After Pelvic Radiation
Status:
SUSPENDED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Awaiting new funding source
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to develop and test an intervention combining physical therapy PT and coping skills training to improve womens sexual function after pelvic radiation
Detailed Description:
Pelvic radiation which is a critical component in the treatment of many gynecologic bladder rectal and anal cancers often results in devastating and long-lasting sexual side effects Vaginal changes following pelvic radiation include adhesions agglutination fibrosis dryness atrophy and stenosis Pelvic radiation-related sexual problems are often undertreated resulting in poor symptom management and reduced quality of life Rehabilitation programs including pelvic floor muscle training PFMT and vaginal dilator exercises may help minimize post-radiation vaginal changes and related sexual problems but use of these rehabilitation strategies is inconsistent and infrequent in routine clinical practice For many women engaging in these rehabilitation strategies can be difficult and adherence is low eg1 to 35 for dilator use Barriers to engaging in PFMT and dilator exercises include lack of information pain embarrassment fear and reliving invasive treatments There is a critical need for interventions to help women access and engage in rehabilitation following pelvic radiation treatment We propose to develop and pilot test a novel physical therapist delivered intervention to improve womens sexual function after pelvic radiation that integrates pelvic health physical therapy interventions ie vaginal dilators PFMT and cognitive-behavioral based coping skills training for managing symptoms and improving treatment adherence Pelvic health physical therapy interventions have demonstrated effectiveness for treating pelvic pain and sexual pain disorders Coping skills training interventions have demonstrated benefits for reducing symptoms and improving treatment engagementThis study includes two phases intervention development and pilot testing For intervention development months 1-6 qualitative data obtained from patient and healthcare provider interviews will be used to develop and refine the integrated PT and coping skills training intervention Using information obtained in qualitative interviews we will develop the intervention In pilot testing months 7-12 we will pilot the developed intervention with women who were treated with pelvic radiation The specific aims of this study are to 1 develop and refine an integrated PT and coping skills training intervention based on qualitative data from interviews with cancer survivors oncology providers and pelvic health physical therapists 2 pilot the developed intervention to examine its feasibility and acceptability and 3 examine the patterns of change and relationships among outcome variables including vaginal changes pelvic floor function sexual function and satisfaction and use of rehabilitation exercises
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