Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

Sexual Dysfunction Clinical Trial

Official title:

Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059586
• Other study ID #: CTO-IUSCCC-0772
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: Namita Agrawal, MD
• Phone: (317)944-2524
• Email: agrawaln[@]indiana.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the feasibility of adding pre-rehabilitation pelvic health physical therapy to standard of care radiation therapy treatment plan for female patients who have been diagnosed with cervical, vaginal, vulvar, uterine, or anal cancer and are a candidate for curative pelvic radiation with external beam. Participants will receive education on using a vaginal dilator for use during treatment and complete questionnaires looking at pain and sexual function.

Description:

Because of the increasing survivorship rate, there is a need for research addressing the post-treatment side effects of pelvic pain and dyspareunia, due to the significant impact these side effects have on patients' quality of life. Current best practice from trained pelvic health physical therapists for addressing dyspareunia and pelvic pain due to vaginal stenosis after radiation therapy, is vaginal dilation. Vaginal dilators are cone shaped durable medical equipment that are inserted into the vagina with lubricant, to assist in patency of the vaginal canal and stretching of the pelvic floor muscles.

The primary objective of this pilot clinical trial is to assess the feasibility of implementing a collaborative, coordinated, and multidisciplinary initiative between radiation oncology and pelvic health physical therapy to answer the following questions: 1) What are the barriers and facilitators to the implementation of a pre-rehabilitation service for gynecological and female anal cancer patients undergoing pelvic radiation and 2) What is the potential clinical value of adding pre-rehabilitative pelvic health services, with an emphasis on vaginal dilator education and use, to the gynecological and female anal cancer radiation setting, in collaboration with radiation oncology staff, as a means of reducing pelvic pain and dyspareunia?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female

2. = 18 years old at the time of informed consent

3. Ability to provide written informed consent and HIPAA authorization

4. Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer

5. Candidate for curative pelvic radiation with external beam, with or without brachytherapy, per radiation oncologist's discretion

Notes:

• Can have prior and/or current modalities of treatment to address diagnosis including surgery and chemotherapy

• Can receive radiation at any facility provided patient is able to perform Physical Therapy visits at IUH North/Schwarz Cancer Center

Exclusion Criteria:

1. Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up.

2. Not a candidate for curative radiation therapy per radiation oncologist's discretion

3. Prior radiation therapy to the pelvis

4. Women who are pregnant or nursing

Related Conditions & MeSH terms

• Dyspareunia
• Pelvic Pain
• Radiation Toxicity
• Sexual Dysfunction

Intervention

Behavioral:
• Pelvic health therapy
Female Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education

Device:
• Dilator feasability
Patient Adherence to Vaginal Dilation Questionnaire

Locations

Country	Name	City	State
United States	IU Health Schwarz Cancer Center	Carmel	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasability of implementation of pre-rehabilitation to radiotherapy	Recording the number of eligible patients for protocol that decline enrollment. The reason(s) for forgoing protocol intervention will be documented.	Baseline
Primary	Feasability of implementation of pre-rehabilitation to radiotherapy	The number of eligible patients that were not identified for protocol enrollment will be recorded and potential gaps in the screening process will be analyzed.	Baseline
Primary	Feasability of implementation of pre-rehabilitation to radiotherapy	The number of eligible patients identified, but not screened, for eligibility or not consented if eligible will be recorded.	Baseline
Primary	Feasability of implementation of pre-rehabilitation to radiotherapy	The duration of time from initial clinical presentation to being offered information of clinical study will be recorded.	Baseline
Primary	Feasability of implementation of pre-rehabilitation to radiotherapy	The duration of time from enrollment on clinical study to being seen by physical therapy will be recorded.	Baseline to 6 weeks
Primary	Feasability of implementation of pre-rehabilitation to radiotherapy	The number of Female Sexual Function Index questionnaires will be recorded as completed, incomplete or not attempted. Reasons for submitting incomplete questionnaires or not submitting a questionnaire will be recorded.	Baseline to 4 months
Secondary	Average score on the Visual Pain Rating Scale.	Visual Analogue Pain Rating Scale 0-10	Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
Secondary	Evaluate female sexual function based on questionnaire responses	Female Sexual Function Index questionnaires (Likert scale)	Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
Secondary	Percentage of adherence to dilator use	Self-reported dilator adherence	Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation