Программный мониторинг токсичности, связанной с лечением, при распространенном почечно-клеточном раке
Мониторинг токсичности, связанной с лечением пероральных таргетных препаратов и иммунотерапии среди пациентов с распространенной почечно-клеточной карциномой (ПКР) с использованием программного обеспечения Carevive, технико-экономическое обоснование фазы II с участием одной группы
Обзор исследования
Статус
Статус
Условия
Условия
Вмешательство/лечение
Вмешательство/лечение
Тип исследования
Тип исследования
Регистрация (Действительный)
Регистрация
Фаза
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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New York
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Rochester, New York, Соединенные Штаты, 14642
- University of Rochester - Wilmot Cancer Institute
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Критерии участия
Критерии приемлемости
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Описание
Критерии включения:
- Диагностика гистологически подтвержденного почечно-клеточного рака любого подтипа с патологоанатомическими или рентгенологическими признаками метастатического заболевания.
- Возраст старше 18 лет
- Участвующий онколог Онкологического центра Уилмота определил, что кандидату следует начать либо пероральную таргетную терапию, либо иммунотерапию для лечения распространенного ПКР; это может быть терапия первой линии или любая последующая линия терапии
- Возможность предоставить письменное информированное согласие
- Владение английским языком и самоотчеты как грамотные
- Должен иметь действующий адрес электронной почты или доступ к интеллектуальному устройству, на которое можно получать текстовые сообщения.
Критерий исключения:
- Женщинам нельзя кормить грудью
- Не имеет постоянного доступа к Интернету
- Невозможно приходить в онкологический центр Уилмота на прием каждые 3-4 месяца для плановых посещений своего основного онколога.
- Субъектам, которые ранее участвовали в исследовании, не будет разрешено повторно участвовать в исследовании в случае изменения лечения.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Количество рук
Оружие и интервенции
Группа участников / АрмияГруппа участников / Армия |
Вмешательство/лечениеВмешательство/лечение |
|---|---|
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Экспериментальный: Использование программного обеспечения Carevive
Отчетность и управление побочными эффектами пероральной таргетной терапии или иммунотерапии с помощью программного обеспечения Carevive у пациентов с распространенным почечно-клеточным раком (ПКР).
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В этом исследовании Carevive предоставит ссылку на участников, чтобы можно было пройти онлайн-опрос.
Опрос будет проводиться еженедельно в течение первых 12 недель исследования, а в дальнейшем будет проводиться через неделю.
Вопросы в основном будут сосредоточены на побочных эффектах лечения рака, а также на нескольких вопросах о соблюдении режима приема лекарств и использовании медицинских услуг.
После завершения опроса субъекту будет предоставлен план ухода с вариантами домашнего контроля токсичности, связанной с наркотиками.
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Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of Participants Who Submitted at Least One Carevive Survey
Временное ограничение: From enrollment through 48 weeks
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Number of participants who completed at least one Carevive survey at any time during the 48 week study period.
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From enrollment through 48 weeks
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Percentage of Carevive Surveys Completed Per Participant
Временное ограничение: From enrollment through 48 weeks
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Percentage of Carevive surveys completed by each participant, calculated as the number of completed surveys divided by the number of surveys prompted by the Carevive software during the 48 week study period.
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From enrollment through 48 weeks
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Number of Participants Who Utilized at Least One Auto-Generated Carevive Care Plan
Временное ограничение: From enrollment through 48 weeks
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Number of participants who accessed at least one auto-generated Carevive care plan at any time during the 48 week study period.
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From enrollment through 48 weeks
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Percentage of Auto Generated Carevive Care Plans Utilized Per Participant
Временное ограничение: From enrollment through 48 weeks
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Percentage of auto generated Carevive care plans utilized by each participant, calculated as the number of care plans accessed divided by the total number of care plans generated for that participant during the 48 week study period.
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From enrollment through 48 weeks
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System Usability Scale (SUS) Score for Carevive Software
Временное ограничение: From enrollment through 48 weeks
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Participants completed the System Usability Scale (SUS), which is a validated 10-item questionnaire that produces a total usability score ranging from 0 to 100.
Scores are categorized into three main categories: excellent (>80.3 points); good (68.0 to 80.3 points) and below average (<68 points).
We calculated the SUS point for each participant who completed the survey.
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From enrollment through 48 weeks
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Вторичные показатели результатов
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score
Временное ограничение: From enrollment through 48 weeks
|
The FKSI-DRS is a validated patient-reported outcome measure assessing kidney cancer-related symptoms, with total scores ranging from 0 to 36, where higher scores indicate better quality of life.
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From enrollment through 48 weeks
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Distress Level Assessed by NCCN Distress Thermometer
Временное ограничение: From enrollment through 48 weeks
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The NCCN Distress Thermometer is a validated patient reported outcome measure assessing psychological distress on a scale from 0 to 10, with higher scores indicating greater distress.
Scores were categorized to reflect low distress (0-3) and moderate to severe distress (4-10).
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From enrollment through 48 weeks
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Health Care Utilization Assessment
Временное ограничение: From enrollment through 48 weeks
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Health care utilization was assessed based on participant self-report and defined as having at least one hospital visit, emergency room visit, or unplanned clinic visit during the 48-week study period.
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From enrollment through 48 weeks
|
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Participants Reporting Diarrhea
Временное ограничение: From enrollment through 48 weeks
|
Number of participants who self reported Diarrhea (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting this symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Nausea
Временное ограничение: From enrollment through 48 weeks
|
Number of participants who self reported nausea (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy.
Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Vomiting
Временное ограничение: From enrollment through 48 weeks
|
Number of participants who self reported vomiting (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy.
Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
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Participants Reporting Fatigue
Временное ограничение: From enrollment through 48 weeks
|
Number of participants who self reported fatigue (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy.
Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Rash
Временное ограничение: From enrollment through 48 weeks
|
Number of participants who self reported rash (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
|
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Participants Reporting Abdominal Pain
Временное ограничение: From enrollment through 48 weeks
|
Number of participants who self reported abdominal pain (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
|
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Participants Reporting Mouth Sores
Временное ограничение: From enrollment through 48 weeks
|
Number of participants who self reported mouth sores (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
|
Participants Reporting Cough
Временное ограничение: From enrollment through 48 weeks
|
Number of participants who self reported cough (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
|
Participants Reporting Shortness of Breath
Временное ограничение: From enrollment through 48 weeks
|
Number of participants who self reported Shortness of Breath (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
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Participants Reporting Anorexia
Временное ограничение: From enrollment through 48 weeks
|
Number of participants who self reported Anorexia (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting this symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
|
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Clinician Reported Diarrhea
Временное ограничение: From enrollment through 48 weeks
|
Number of participants with clinician reported diarrhea assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
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From enrollment through 48 weeks
|
|
Clinician Reported Nausea
Временное ограничение: From enrollment through 48 weeks
|
Number of participants with clinician reported nausea assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Vomiting
Временное ограничение: From enrollment through 48 weeks
|
Number of participants with clinician reported vomiting assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Fatigue
Временное ограничение: From enrollment through 48 weeks
|
Number of participants with clinician reported fatigue assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Rash
Временное ограничение: From enrollment through 48 weeks
|
Number of participants with clinician reported Rash assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Abdominal Pain
Временное ограничение: From enrollment through 48 weeks
|
Number of participants with clinician reported Abdominal Pain assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Mouth Sores
Временное ограничение: From enrollment through 48 weeks
|
Number of participants with clinician reported Mouth Sores assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Cough
Временное ограничение: From enrollment through 48 weeks
|
Number of participants with clinician reported Cough assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Shortness of Breath
Временное ограничение: From enrollment through 48 weeks
|
Number of participants with clinician reported Shortness of Breath assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Anorexia
Временное ограничение: From enrollment through 48 weeks
|
Number of participants with clinician reported Anorexia assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
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Соавторы и исследователи
Спонсор
Спонсор
Соавторы
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Начало исследования
Первичное завершение (Действительный)
Первичное завершение
Завершение исследования (Действительный)
Завершение исследования
Даты регистрации исследования
Первый отправленный
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Первый опубликованный
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее опубликованное обновление
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Урогенитальные новообразования
- Новообразования по локализации
- Новообразования
- Мужские мочеполовые заболевания
- Заболевания почек
- Урологические заболевания
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Новообразования по гистологическому типу
- Новообразования железистые и эпителиальные
- Аденокарцинома
- Урологические новообразования
- Новообразования почек
- Карцинома
- Карцинома, почечно-клеточная
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- UGUK 17036
- UG1CA189961 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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