Improving Women's Function After Pelvic Radiation

NCT04544735 | Active Not Recruiting

• 1 other identifier: Pro00105435
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Dysfunction; Pelvic Floor Disorders; Gynecologic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Session Attendance

  Treatment feasibility will be assessed by measuring the session attendance rate for each participant

  Following completion of the intervention, up to 12 months

• Attkisson & Zwick's Client Satisfaction Questionnaire

  18 item questionnaire to measure and assess consumer satisfaction with health and human services.

  3 months post intervention

Secondary Outcomes (6)

• Sexual Vaginal Changes Questionnaire

  Baseline and 3 months post intervention

• Australian Pelvic Floor Questionnaire

  Baseline and 3 month post intervention

• PROMIS Sexual Function and Satisfaction Measure Full Profile (Female)

  Baseline and 3 months post intervention

• Generalized Anxiety Disorder Screener (GAD-7)

  Baseline and 3 months post intervention

• Patient Health Questionnaire Depression Screener (PHQ-9)

  Baseline and 3 months post intervention

Study Arms (1)

Integrated Physical Therapy and Coping Skills Training

EXPERIMENTAL

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

Behavioral: Integrated Physical Therapy and Coping Skills Training

Interventions

Integrated Physical Therapy and Coping Skills Training 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

Integrated Physical Therapy and Coping Skills Training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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
• years of age or older
• Able to speak/read English
• Able to give meaningful informed consent
• Major untreated or uncontrolled mental illness (e.g., schizophrenia)
• Unable to provide informed consent

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Rebecca Shelby, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 10, 2020
• Study Start: October 7, 2020
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)