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Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

Primary Purpose

Dyspareunia, Pelvic Pain, Sexual Dysfunction

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pelvic health therapy
Dilator feasability
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dyspareunia focused on measuring vaginal dilator, pelvic health physical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female ≥ 18 years old at the time of informed consent Ability to provide written informed consent and HIPAA authorization Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer 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: 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. Not a candidate for curative radiation therapy per radiation oncologist's discretion Prior radiation therapy to the pelvis Women who are pregnant or nursing

Sites / Locations

  • IU Health Schwarz Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pelvic health Assessment and Intervention

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Average score on the Visual Pain Rating Scale.
Visual Analogue Pain Rating Scale 0-10
Evaluate female sexual function based on questionnaire responses
Female Sexual Function Index questionnaires (Likert scale)
Percentage of adherence to dilator use
Self-reported dilator adherence

Full Information

First Posted
September 22, 2023
Last Updated
October 3, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT06059586
Brief Title
Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
Official Title
Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspareunia, Pelvic Pain, Sexual Dysfunction, Radiation Toxicity
Keywords
vaginal dilator, pelvic health physical therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pelvic health Assessment and Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Pelvic health therapy
Intervention Description
Female Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education
Intervention Type
Device
Intervention Name(s)
Dilator feasability
Intervention Description
Patient Adherence to Vaginal Dilation Questionnaire
Primary Outcome Measure Information:
Title
Feasability of implementation of pre-rehabilitation to radiotherapy
Description
Recording the number of eligible patients for protocol that decline enrollment. The reason(s) for forgoing protocol intervention will be documented.
Time Frame
Baseline
Title
Feasability of implementation of pre-rehabilitation to radiotherapy
Description
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.
Time Frame
Baseline
Title
Feasability of implementation of pre-rehabilitation to radiotherapy
Description
The number of eligible patients identified, but not screened, for eligibility or not consented if eligible will be recorded.
Time Frame
Baseline
Title
Feasability of implementation of pre-rehabilitation to radiotherapy
Description
The duration of time from initial clinical presentation to being offered information of clinical study will be recorded.
Time Frame
Baseline
Title
Feasability of implementation of pre-rehabilitation to radiotherapy
Description
The duration of time from enrollment on clinical study to being seen by physical therapy will be recorded.
Time Frame
Baseline to 6 weeks
Title
Feasability of implementation of pre-rehabilitation to radiotherapy
Description
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.
Time Frame
Baseline to 4 months
Secondary Outcome Measure Information:
Title
Average score on the Visual Pain Rating Scale.
Description
Visual Analogue Pain Rating Scale 0-10
Time Frame
Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
Title
Evaluate female sexual function based on questionnaire responses
Description
Female Sexual Function Index questionnaires (Likert scale)
Time Frame
Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
Title
Percentage of adherence to dilator use
Description
Self-reported dilator adherence
Time Frame
Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female ≥ 18 years old at the time of informed consent Ability to provide written informed consent and HIPAA authorization Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer 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: 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. Not a candidate for curative radiation therapy per radiation oncologist's discretion Prior radiation therapy to the pelvis Women who are pregnant or nursing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Namita Agrawal, MD
Phone
(317)944-2524
Email
agrawaln@indiana.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Dutkevich, RN
Phone
(317)278-5618
Email
sdutkevi@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Namita Agrawal, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Health Schwarz Cancer Center
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Spittler
Phone
317-274-0771
Email
ajspittl@iu.edu

12. IPD Sharing Statement

Learn more about this trial

Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

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