Evaluating the Impact of Limited Compared With Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Stage II-III Soft Tissue Sarcoma of the Trunk and Extremities
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Chest Radiography, Computed Tomography, Follow-Up, Follow-Up.
- Кому может быть актуально
- Состояния в реестре: Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8. Базовые параметры: от 18 лет · Все.
- 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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Официальное название
Evaluating the Impact of Limited vs. Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Soft Tissue Sarcoma
Обзор
This phase II trial studies how anxiety is affected by 2 types of follow-up after surgery, limited follow-up and intense follow-up, in patients with stage II-III soft tissue sarcoma of the trunk and extremities. In cancer survivors, the fear of cancer coming back (recurring) is common and may persist long after the end of treatment. It may also be exacerbated by return visits for imaging (surveillance). The purpose of this study is to determine how patients' anxiety and other cancer-related outcomes are affected by how often surveillance is done.
Подробное описание
PRIMARY OBJECTIVE:
I. To evaluate whether a risk-based limited follow-up surveillance is associated with reduced patient anxiety compared to risk-based intense surveillance.
SECONDARY OBJECTIVE:
I. To evaluate the impact of reduced surveillance in low-risk patients on overall survival, time to local or distant recurrence, anxiety at early and late time-points, out of pocket costs, and number of missed or extra clinic visits, compared to the risk-based intense follow-up in both low-risk and high-risk patients.
OUTLINE: Patients are assigned to 1 of 2 groups based on risk status.
GROUP 1 (LOW RISK): Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with computed tomography (CT)-chest and imaging of the primary site.
ARM II: Patients undergo limited follow-up every 6 months for 2 years consisting of restaging with either CT-chest or chest x-ray (CXR) and imaging of the primary site.
GROUP 2 (HIGH RISK): Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.
Вмешательства
- Процедура Chest Radiography
Undergo CXR - Процедура Computed Tomography
Undergo CT-chest - Процедура Follow-Up
Undergo intense follow-up - Процедура Follow-Up
Undergo limited follow-up - Процедура Imaging Technique
Undergo imaging - Другое Questionnaire Administration
Ancillary studies
Первичные конечные точки
- Total score for Fear of Cancer Recurrence Inventory - Short Form [Срок оценки: Baseline to 12 months after surgery]
- Mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form [Срок оценки: Up to 12 months after surgery]
Вторичные конечные точки (8)
- Change in fear of recurrence [Срок оценки: Baseline up to 24 months post-resection]
- Change in distress [Срок оценки: Baseline up to 24 months post-resection]
- Change in anxiety and depression [Срок оценки: Baseline up to 24 months post-resection]
- Change in out-of-pocket costs [Срок оценки: Baseline up to 24 months post-resection]
- Time to local recurrence [Срок оценки: From time of surgery to local recurrence as defined by Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause, whichever occurs first, assessed up to 2 years]
- Time to distant metastasis [Срок оценки: From time of surgery to distant metastasis as defined by RECIST or death from any cause, whichever occurs first, assessed up to 2 years]
- Overall survival [Срок оценки: From time of surgery to death, assessed up to 2 years]
- Number of missed or extra clinic visits [Срок оценки: Up to 2 years]
Критерии участия
IInclusion Criteria:
- ≥18 years old
- Completion of sarcoma therapy (chemotherapy, radiation therapy and/or surgery) within 8-14 weeks of study enrollment
- Willingness to complete surveys x 2 years
Критерии исключения
- Documented metastatic disease at the time of enrollment
- Non-English-speaking patients
Pregnant women will be included in this clinical trial.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- M D Anderson Cancer Center — Houston
Идентификаторы
NCT: NCT04751409 · 2020-0854 · NCI-2021-00436 · 2020-0854