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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06059586
Other study ID # CTO-IUSCCC-0772
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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