Daily Stress Process and Daily Cognitive Performance Among Racially Diverse Breast Cancer Survivors: A Feasibility and Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Completion rate of the 14-day mobile daily diary survey
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Cannot provide informed consent
结局指标
主要结局
Completion rate of the 14-day mobile daily diary survey
时间窗: Daily, from Day 2 through Day 15
The feasibility of the mobile daily diary method will be based on calculating the percentage of completed daily diary surveys as well as percentages of completed morning and evening surveys. An accepted completion rate is predetermined at the level of 70% or higher
次要结局
- predictive validity of the Daily Inventory of Stressful Experiences (DISE)(Daily, from Day 2 through Day 15)
- internal reliability of Ambulatory Cognitive Assessment measures(Twice Daily, from Day 2 through Day 15)
- predictive validity of Ambulatory Cognitive Assessment measures(Twice Daily, from Day 2 through Day 15)
- internal reliability of Cognitive Interference and Memory Lapses scale(Daily, from Day 2 through Day 15)