Clinical Trial Details
— Status: Suspended
Administrative data
NCT number |
NCT04544735 |
Other study ID # |
Pro00105435 |
Secondary ID |
|
Status |
Suspended |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 7, 2020 |
Est. completion date |
October 2024 |
Study information
Verified date |
October 2023 |
Source |
Duke University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of the study is to develop and test an intervention combining physical therapy
(PT) and coping skills training to improve women's sexual function after pelvic radiation.
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 (e.g.,1% 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 women's sexual function after
pelvic radiation that integrates pelvic health physical therapy interventions (i.e., 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 engagement.This 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.