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Идёт набор NCT06059586

Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

Без фазы С лечением Dyspareunia Pelvic Pain Sexual Dysfunction Radiation Toxicity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pelvic health therapy, Dilator feasability.
Кому может быть актуально
Состояния в реестре: Dyspareunia, Pelvic Pain, Sexual Dysfunction, Radiation Toxicity. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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?

Вмешательства

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

Первичные конечные точки

  • Feasability of implementation of pre-rehabilitation to radiotherapy [Срок оценки: Baseline]
  • Feasability of implementation of pre-rehabilitation to radiotherapy [Срок оценки: Baseline]
  • Feasability of implementation of pre-rehabilitation to radiotherapy [Срок оценки: Baseline]
  • Feasability of implementation of pre-rehabilitation to radiotherapy [Срок оценки: Baseline]
  • Feasability of implementation of pre-rehabilitation to radiotherapy [Срок оценки: Baseline to 6 weeks]
  • Feasability of implementation of pre-rehabilitation to radiotherapy [Срок оценки: Baseline to 4 months]
Вторичные конечные точки (3)
  • Average score on the Visual Pain Rating Scale. [Срок оценки: 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 [Срок оценки: Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation]
  • Percentage of adherence to dilator use [Срок оценки: Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 3 центра
  • IU Health West — Avon
  • IU Health Schwarz Cancer Center — Carmel
  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis

Идентификаторы

NCT: NCT06059586 · CTO-IUSCCC-0772

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗