Improving Women's Function After Pelvic Radiation

NCT ID: NCT04544735

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-07
• Study Completion Date: 2026-05-31

Brief 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.

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 (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.

Conditions

Sexual Dysfunction; Pelvic Floor Disorders; Gynecologic Cancer

Keywords

Pelvic radiation; Sexual side effects; Pelvic health physical therapy; Cancer survivors; Intimacy dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Integrated Physical Therapy and Coping Skills Training

The proposed intervention will will integrate two key components: pelvic health PT interventions (i.e., vaginal dilators, Pelvic Floor Muscle Training) and coping skills training for managing symptoms and improving treatment adherence. The intervention aims to improve women's sexual function after pelvic radiation

Group Type: EXPERIMENTAL

Integrated Physical Therapy and Coping Skills Training

Intervention Type: BEHAVIORAL

The proposed intervention will provide pelvic health physical therapy interventions including: education about vaginal moisturizers and lubricants, low back and hip assessment and instruction in accommodations (e.g., strategies for accommodating sexual position of choice), instruction in vulvar massage, instruction and facilitation of vaginal dilator use, and pelvic floor muscle training (PFMT) and exercises. Women will be given a set of vaginal dilators. Cognitive behavioral techniques that have been successfully used by physical therapists in prior intervention studies will be integrated into the PT intervention including breathing and relaxation techniques, guided imagery, systematic desensitization, cognitive restructuring techniques and coping thoughts, and problem solving

Interventions

Integrated Physical Therapy and Coping Skills Training

The proposed intervention will provide pelvic health physical therapy interventions including: education about vaginal moisturizers and lubricants, low back and hip assessment and instruction in accommodations (e.g., strategies for accommodating sexual position of choice), instruction in vulvar massage, instruction and facilitation of vaginal dilator use, and pelvic floor muscle training (PFMT) and exercises. Women will be given a set of vaginal dilators. Cognitive behavioral techniques that have been successfully used by physical therapists in prior intervention studies will be integrated into the PT intervention including breathing and relaxation techniques, guided imagery, systematic desensitization, cognitive restructuring techniques and coping thoughts, and problem solving

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of non-metastatic gynecologic (cervical, endometrial, vaginal, vulvar), anal, rectal, or bladder cancer
• Completed pelvic radiation treatment within the last 5 years
• 18 years of age or older
• Able to speak/read English
• Able to give meaningful informed consent

• Diagnosis of non-metastatic gynecologic (cervical, endometrial, vaginal, vulvar), anal, rectal, or bladder cancer
• Completed pelvic radiation treatment in the past 2 to 24 months
• 18 years of age or older
• Able to speak/read English
• Able to give meaningful informed consent

Exclusion Criteria

• Major untreated or uncontrolled mental illness (e.g., schizophrenia)
• Unable to provide informed consent

Medical Providers Participating in Intervention Development Interviews

Eligibility Criteria:

• Oncology providers (e.g., radiation, medical, and surgical oncologists; nurses; advanced practice professionals) who provide care to women who receive pelvic radiation for gynecologic, anal, rectal or bladder cancers.
• Physical therapists with specialized certification in pelvic health or women's health physical therapy who provide care to patients in the outpatient setting.

Cancer Survivor User Testers

• Major untreated or uncontrolled mental illness (e.g., schizophrenia)
• Unable to provide informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Shelby, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00105435

Identifier Type: -

Identifier Source: org_study_id