Surviving Daily Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mobile Daily Diary.
- Who it may be relevant to
- Registry conditions: Stress, Cognitive Change, Breast Cancer, Breast Carcinoma. Basic parameters: from 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Daily Stress Process and Daily Cognitive Performance Among Racially Diverse Breast Cancer Survivors: A Feasibility and Validation Study
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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.
Primary outcome measures
- Completion rate of the 14-day mobile daily diary survey [Time frame: Daily, from Day 2 through Day 15]
Secondary outcome measures (4)
- predictive validity of the Daily Inventory of Stressful Experiences (DISE) [Time frame: Daily, from Day 2 through Day 15]
- predictive validity of Ambulatory Cognitive Assessment measures [Time frame: Twice Daily, from Day 2 through Day 15]
- internal reliability of Ambulatory Cognitive Assessment measures [Time frame: Twice Daily, from Day 2 through Day 15]
- internal reliability of Cognitive Interference and Memory Lapses scale [Time frame: Daily, from Day 2 through Day 15]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
- Under 40
- Cannot provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Thomas Jefferson University — Philadelphia
Identifiers
NCT: NCT07054723 · iRISID-2025-0027 · JT 44399