Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pelvic health therapy, Dilator feasability.
- Who it may be relevant to
- Registry conditions: Dyspareunia, Pelvic Pain, Sexual Dysfunction, Radiation Toxicity. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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?
Interventions
- 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
Primary outcome measures
- Feasability of implementation of pre-rehabilitation to radiotherapy [Time frame: Baseline]
- Feasability of implementation of pre-rehabilitation to radiotherapy [Time frame: Baseline]
- Feasability of implementation of pre-rehabilitation to radiotherapy [Time frame: Baseline]
- Feasability of implementation of pre-rehabilitation to radiotherapy [Time frame: Baseline]
- Feasability of implementation of pre-rehabilitation to radiotherapy [Time frame: Baseline to 6 weeks]
- Feasability of implementation of pre-rehabilitation to radiotherapy [Time frame: Baseline to 4 months]
Secondary outcome measures (3)
- Average score on the Visual Pain Rating Scale. [Time frame: Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation]
- Evaluate female sexual function based on questionnaire responses [Time frame: Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation]
- Percentage of adherence to dilator use [Time frame: Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- IU Health West — Avon
- IU Health Schwarz Cancer Center — Carmel
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis
Identifiers
NCT: NCT06059586 · CTO-IUSCCC-0772