Surviving Daily Life
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: Mobile Daily Diary.
- Кому может быть актуально
- Состояния в реестре: Stress, Cognitive Change, Breast Cancer, Breast Carcinoma. Базовые параметры: от 40 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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Официальное название
Daily Stress Process and Daily Cognitive Performance Among Racially Diverse Breast Cancer Survivors: A Feasibility and Validation Study
Обзор
The primary goal of this project is to evaluate the feasibility of a 14-day mobile daily diary study among racially diverse breast cancer survivors. Further, the investigators will examine the validity and reliability of the daily stress and daily cognitive performance measures among breast cancer survivors. This pilot project will recruit 30 racially diverse breast cancer survivors (Asian, Black, Latina, and white; ages 40 and older; at least five years post-diagnosis) who are patients at the Sidney Kimmel Comprehensive Cancer Center. The daily diary survey questions will be available in English, Spanish, and Chinese to accommodate the preferred language of the target participants.
Подробное описание
This is a pilot study that will assess the feasibility of a 14-day mobile daily diary survey to measure daily stress and cognitive performance among long-term breast cancer survivors.
Participants will be recruited from the Sidney Kimmel Cancer Center (SKCC) at Thomas Jefferson University (TJU). Potential participants will be identified via the SKCC/TJU Tumor Registry. Potential participants will be contacted with their cancer care team approval. Contact may be accomplished via an upcoming clinical appointment, phone, email, or MyChart (RLS) depending on the patient's communication preference or clinical team guidance.
Participants will start study procedures by completing the baseline survey using the mobile phone (day 1) to collect demographic and socioeconomic status information. Starting from day 2 to day 14, participants will complete the short morning (2-3 min) and slightly longer (5-7 min) evening mobile daily diary surveys. The morning survey asks questions about sleep, morning outlook, and anticipatory stress and positive experiences. The evening survey asks questions about the respondent's daily experiences (stressors, mood, physical symptoms). After each survey, respondents will complete three brief objective cognitive tasks. To minimize the risk of data breach, all the information from the survey will be stored on the password protected study mobile phone. The study mobile phones will be set up to ensure that it can only be used for study purposes, that is, participants are unable to make phone calls or connect to the internet with the study phone.
Findings from this pilot project will provide critical preliminary evidence regarding the feasibility of a mobile daily diary method among racially diverse breast cancer survivors, as well as the reliability and validity of the important measures related to daily stress, daily cognitive performance, and daily cognitive problems in racially diverse populations.
Вмешательства
- Поведенческое Mobile Daily Diary
This study will include a 14-day daily diary survey in which participants will be expected to complete morning (\~5 minutes) and night (\~10 minutes) assessments using mobile phones provided by the research team.
Первичные конечные точки
- Completion rate of the 14-day mobile daily diary survey [Срок оценки: Daily, from Day 2 through Day 15]
Вторичные конечные точки (4)
- predictive validity of the Daily Inventory of Stressful Experiences (DISE) [Срок оценки: Daily, from Day 2 through Day 15]
- predictive validity of Ambulatory Cognitive Assessment measures [Срок оценки: Twice Daily, from Day 2 through Day 15]
- internal reliability of Ambulatory Cognitive Assessment measures [Срок оценки: Twice Daily, from Day 2 through Day 15]
- internal reliability of Cognitive Interference and Memory Lapses scale [Срок оценки: Daily, from Day 2 through Day 15]
Критерии участия
Критерии включения
Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- Individuals 40 or older
- Five or more years after breast cancer diagnosis
- Self-identified as Asian, Black, Latina, or white
- Able to read in English, Spanish, or Chinese
Критерии исключения
An individual who meets any of the following criteria will be excluded from participation in this study:
- Under 40
- Cannot provide informed consent
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 · 1 центр
- Thomas Jefferson University — Philadelphia
Идентификаторы
NCT: NCT07054723 · iRISID-2025-0027 · JT 44399