Clinical trial NCT06059586: Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
Official title: Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dyspareunia
Pelvic Pain
Sexual Dysfunction
Radiation Toxicity
Keywords: vaginal dilator
pelvic health physical therapy
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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?

Eligibility criteria: 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

Primary outcomes:
measure: Feasability of implementation of pre-rehabilitation to radiotherapy
timeFrame: Baseline
measure: Feasability of implementation of pre-rehabilitation to radiotherapy
timeFrame: Baseline
measure: Feasability of implementation of pre-rehabilitation to radiotherapy
timeFrame: Baseline
measure: Feasability of implementation of pre-rehabilitation to radiotherapy
timeFrame: Baseline
measure: Feasability of implementation of pre-rehabilitation to radiotherapy
timeFrame: Baseline to 6 weeks
measure: Feasability of implementation of pre-rehabilitation to radiotherapy
timeFrame: Baseline to 4 months
Secondary outcomes:
measure: Average score on the Visual Pain Rating Scale.
timeFrame: Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
measure: Evaluate female sexual function based on questionnaire responses
timeFrame: Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
measure: Percentage of adherence to dilator use
timeFrame: Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
Other outcomes:
Locations:
city: Carmel
country: United States
facility: IU Health Schwarz Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Namita Agrawal, MD
role: PRINCIPAL_INVESTIGATOR
References: