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Идёт набор NCT05108298

Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials

Без фазы С лечением Breast Cancer, NOS CNS Primary Tumor, NOS Cervical Cancer, NOS Colorectal Cancer, NOS

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: Questionnaires.
Кому может быть актуально
Состояния в реестре: Breast Cancer, NOS, CNS Primary Tumor, NOS, Cervical Cancer, NOS, Colorectal Cancer, NOS. Базовые параметры: 18 лет — 39 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
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Обзор

The purpose of this study is to evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.

Подробное описание

Primary Aim: Conduct a pilot randomized controlled trial with AYAs to determine the feasibility and acceptability of completing PROs informed by AYAs' priorities. AYAs will be consented and randomized to select five HRQOL domains from a dashboard (Choice PRO) at each assessment period or to five standard HRQOL domains (Fixed PRO; physical function, pain, cognitive function, social support, finances) at each assessment period. AYAs will complete baseline, 1-, 3-, 6-, and 12-month assessments which will include a combination of CATs and static short forms. Feasibility will be operationalized as ≥ 75% completed PROs and ≥ 75% acceptability. Feasibility and acceptability will be compared between AYAs randomized to Choice PRO vs Fixed PRO. Adherence boosters (reminder calls, text messages) will be used to minimize missing data and evaluated as moderators.

Exploratory Aim: Solicit AYA preferences for how their PRO data should be shared with them and/or their providers. To inform future research, AYAs will be asked if and how participants want their PRO data to be used by their medical teams as well as if and how participants want their PRO data to be shared with them and their families.

The investigators anticipate PROMIS CATs will increase capacity for PRO data capture, AYAs randomized to Choice PRO, who are given the opportunity to choose which PRO domains to complete, will have less missing data. The investigators expect the majority of AYAs will want PRO feedback for themselves, their families, and their providers. Findings will promote and sustain the inclusion of PROs in clinical and supportive care trials, providing AYA's a voice and informing future patient-centered care tailored to the diverse needs of AYAs. By offering AYAs the opportunity to choose which PRO domains to complete based on relevance to their health-related quality of life, as opposed to completing domains pre-determined by the research team, the investigators raise the patient-centeredness of investigators assessment approach.

Вмешательства

  • Другое Questionnaires
    Patients will complete questionnaires online through EASEE-PRO. There will be a set of fixed questionnaires at each timepoint for both arms. The patients will be asked to rank the 15 types of PROs according to their importance. The participants randomized to the choice arm will be asked to choose 5 of the 15 PROs to complete. The participants randomized to the fixed arm will be given a fixed 5 of the 15 PROs at each time point.

Первичные конечные точки

  • Evaluate completion of PROs among AYAs randomized to Choice PRO vs Fixed PRO. [Срок оценки: Feasibility at 1 month and acceptability at baseline]

Критерии участия

Критерии включения

Patient must be ≥ 18 years and ≤ 39 years of age at registration. Patient must have a histologically confirmed diagnosis of primary cancer of any stage within 12 weeks (84 days) at registration.

Patient must have received, be currently receiving or planning to receive treatment for cancer, including surgery and/or chemotherapy and/or radiation therapy.

Patient must have an ECOG performance status 0-3. Patient must have a life expectancy >24 months. Patient must be able to complete questionnaires in English. Patient must have internet access through computer, tablet, or smartphone. Patient must have an email address. Patient must have a mobile phone able with text messaging capabilities. Patient must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact).

Patient must be able to provide informed consent.

Критерии исключения

Patient must not have a recurrence or second primary cancer. Patients must not have basal cell skin carcinoma.

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
Организация здравоохранения

Центры проведения

США · 347 центров
  • Fairbanks Memorial Hospital — Fairbanks
  • Kingman Regional Medical Center — Kingman
  • Cancer Center at Saint Joseph's — Phoenix
  • Mercy Hospital Fort Smith — Fort Smith
  • CHI Saint Vincent Cancer Center Hot Springs — Hot Springs
  • CARTI Cancer Center — Little Rock
  • Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande
  • PCR Oncology — Arroyo Grande
  • … и ещё 339 центров

Идентификаторы

NCT: NCT05108298 · EAQ202 · NCI-2021-07529 · EAQ202 · ECOG-ACRIN-EAQ202 · EAQ202

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗