Gender Related Coping and Survivorship for Genitourinary Cancers
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: Additional Education, Questionnaires, Attendance Diary.
- Кому может быть актуально
- Состояния в реестре: Bladder 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
- 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
This research is being done to learn more about coping and survivorship of women with bladder cancer, specifically regarding psychosocial distress and sexual dysfunction. This study is a non-therapeutic study and will randomize participants to a standard of care group and education group. Patients in both groups will be asked to complete surveys regarding their mood and sexual function. Patients in the intervention group will be asked to complete attendance diaries regarding educational and support services utilized. Participants' clinical data will also be collected.
Подробное описание
The Gender Related Coping and Survivorship Study for Genitourinary Cancers is focused on providing patients with additional education to promote sexual function in female bladder cancer patients with the aim to help decrease demoralization and sexual dysfunction. Patients receiving a cystectomy and patients not receiving a cystectomy will be randomized separately into an additional education or standard of care group. The additional education consists of asking patients to attend the Women and Bladder Cancer Educational Series, Women's Bladder Cancer Support Group meetings, referrals to other support services, receiving supplemental handouts and treating physician led counseling incorporated into standard of care visits. All participants will be asked to complete the Demoralization Scale-II and Female Sexual Function Index at baseline, one-month following treatment, three-months following treatment, six-months following treatment, and one year following treatment. Patients randomized to the additional education group will also be asked to complete an attendance diary one-month following treatment, three-months following treatment, six-months following treatment, and one year following treatment.
Вмешательства
- Другое Additional Education
Study-Specific Patient Handouts, Treating-Provider led counseling, Women's Bladder Cancer Support Group, Women's Bladder Cancer Educational Series, and referrals for additional support services - Другое Questionnaires
Female Sexual Function Index, Demoralization Scale-II - Другое Attendance Diary
Attendance Diaries for the Women's Bladder Cancer Support Group, Women's Bladder Cancer Educational Series, and additional educational and support services utilized
Первичные конечные точки
- Use Demoralization Scale-II to assess change in demoralization [Срок оценки: Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment]
Вторичные конечные точки (4)
- Use Female Sexual Function Index (FSFI) to assess change in sexual function [Срок оценки: Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment]
- Change in coping as assessed by Demoralization Scale II [Срок оценки: Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment]
- Change in coping as assessed by the Female Sexual Function Index (FSFI) [Срок оценки: Baseline, 1-Month after Treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment]
- Survivorship [Срок оценки: Baseline, 1-Month after treatment, 3-Months after Treatment, 6-Months after Treatment, 1-year after Treatment]
Критерии участия
Критерии включения
- Females with bladder cancer
- Willing to answer surveys regarding their psychosocial health and sexual health
Критерии исключения
- Not undergoing either active treatment or active surveillance (i.e. patients on hospice care)
- Patients with cognitive impairments
- Women who are pregnant
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 2 центра
- Sibley Memorial Hospital — Washington D.C.
- Johns Hopkins Hospital — Baltimore
Идентификаторы
NCT: NCT05649306 · IRB00314755