Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

Part of paid clinical trials in Avon, Indiana.

Sponsor
Indiana University
Study ID
NCT06059586
Status
Recruiting
Apply to this trial

Conditions

  • Dyspareunia
  • Pelvic Pain
  • Radiation Toxicity
  • Sexual Dysfunction

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pelvic health therapy — BEHAVIORAL
    Female Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education
  • Dilator feasability — DEVICE
    Patient Adherence to Vaginal Dilation Questionnaire

Study Details

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.

Key Dates

Start date
Jan 16, 2024
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Pelvic health Assessment and Intervention

Primary Outcome Measure

Feasability of implementation of pre-rehabilitation to radiotherapy [ Time Frame: Baseline ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
IU Health WestAvonIndiana46123
Nikki Barrow
[email protected]
317-944-1242
IU Health Schwarz Cancer CenterCarmelIndiana46032
John Spittler
[email protected]
3172740771
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Sarah Dutkevitch, RN
[email protected]
317-278-5618

Find similar trials in Avon, IN

By research site
IU Health West· Avon, INIU Health Schwarz Cancer Center· Carmel, INIndiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, IN

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