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Идёт набор NCT07296237

Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer

— Наблюдательное Anal Cancer

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Anal Cancer. 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
Дания
Следующий шаг
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Официальное название

DACG VI. Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer

Обзор

The goal of this observational study is to learn how radiotherapy for anal cancer affects the vaginal and sexual health of women after treatment. The study will also look at whether the radiation dose to the vagina is linked to the level of vaginal problems. The main questions this study aims to answer are: * How many women develop moderate or severe narrowing of the vagina after radiotherapy? * Is there a link between the radiation dose and vaginal problems? * How do vaginal changes affect sexual health and daily life? * What care and support do women receive, and how satisfied are they with this support? Participants are women aged 18 years or older who were treated with chemotherapy and radiotherapy for anal cancer and are 6 to 36 months after treatment. Participants will: Have a gynaecological examination to check the vagina for changes such as narrowing, stiffness, bleeding, or scarring Complete online questionnaires about quality of life and sexual health Answer questions about use of vaginal dilators, hormone treatment, and sexual counselling Allow researchers to analyse their radiotherapy scans to measure how much radiation the vagina received Some participants will also take part in a telephone interview about their experience with guidance and support after treatment The study will include about 80 participants across three Danish hospitals. About 20 participants will take part in the interview part of the study. The results from this study may help improve how doctors and nurses prevent, detect, and treat vaginal and sexual problems after radiotherapy for anal cancer. This may lead to better support and quality of life for future patients.

Первичные конечные точки

  • Prevalence of moderate to severe vaginal stenosis after radiotherapy for anal cancer [Срок оценки: Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy]
Вторичные конечные точки (5)
  • Gynecological findings at examination after radiotherapy for anal cancer [Срок оценки: Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy]
  • Patient-reported sexual health and quality of life after radiotherapy for anal cance [Срок оценки: Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy]
  • Use of vaginal dilators, hormone treatment, and sexual counselling after radiotherapy [Срок оценки: Single questionnaire assessment at study visit, 6 to 36 months after completion of chemoradiotherapy]
  • Radiation dose to the vagina and its relation to vaginal stenosis [Срок оценки: Retrospective analysis of radiotherapy plans after study inclusion]
  • Patient satisfaction with guidance on gynecological and sexual side effects [Срок оценки: Single telephone interview within 3 months after study inclusion]

Критерии участия

Критерии включения

  • Women aged 18 years or older
  • Diagnosed with anal cancer
  • Treated with chemoradiotherapy with curative intent
  • Between 6 and 36 months since completion of radiotherapy
  • Able and willing to give written informed consent

Критерии исключения

  • Previous pelvic radiotherapy for another disease
  • Treated with electron beam radiotherapy
  • Unable to speak or understand Danish

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Дания · 3 центра
  • Department of Oncology Aarhus University Hospital (AUH) — Aarhus
  • Department of Oncology, Herlev and Gentofte Hospital — Herlev
  • Department of Oncology Vejle Hospital, University Hospital of Southern Denmark — Vejle

Идентификаторы

NCT: NCT07296237 · 1-10-72-19-25 · 1-10-72-19-25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗