Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Pelvic health therapy
BehavioralFemale Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education
Dilator feasability
DevicePatient Adherence to Vaginal Dilation Questionnaire
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Pelvic health Assessment and InterventionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Baseline3
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.
Time frame
Baseline4
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.
Time frame
BaselineSecondary outcomes
1
Average score on the Visual Pain Rating Scale.
Visual Analogue Pain Rating Scale 0-10
Time frame
4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation2
Evaluate female sexual function based on questionnaire responses
Female Sexual Function Index questionnaires (Likert scale)
Time frame
4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation3
Percentage of adherence to dilator use
Self-reported dilator adherence
Time frame
4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov