Breast Cancer, Breast Carcinoma, Breast Neoplasm, Cognitive Change, Cognitive Dysfunction, Stress
Conditions
Keywords
Mobile Survey, Daily Diary, Breast Cancer Survivors
Brief summary
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
BEHAVIORALMobile 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.
Sponsors
Thomas Jefferson University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion rate of the 14-day mobile daily diary survey | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| predictive validity of the Daily Inventory of Stressful Experiences (DISE) | Daily, from Day 2 through Day 15 | Predictive validity of the daily stressor exposure and severity will be conducted by testing the within-person and between-person associations between daily stressor exposure and severity with daily negative and positive affect, daily cognitive performance, and daily cognitive problems. |
| predictive validity of Ambulatory Cognitive Assessment measures | Twice Daily, from Day 2 through Day 15 | Construct validity of the daily cognitive assessment measures will be assessed by conducting a multilevel confirmatory factor analysis (CFA) to assess the fit of our hypothesized measurement model. |
| internal reliability of Ambulatory Cognitive Assessment measures | Twice Daily, from Day 2 through Day 15 | Between-person reliability (higher intraclass correlation is expected, thus no calculation of within-person reliability) by calculating internal consistency (i.e., Cronbach's alpha) across all persons and days. |
| internal reliability of Cognitive Interference and Memory Lapses scale | Daily, from Day 2 through Day 15 | Between-person reliability (higher intraclass correlation is expected, thus no calculation of within-person reliability) by calculating internal consistency (i.e., Cronbach's alpha) across all persons and days. PROMIS® v2.0 - Cognitive Function Scoring: * Raw Score Range: Varies by short form: * 4-item: 4-20 * 6-item: 6-30 * 8-item: 8-40 T-Score Range: \ 22 to 65 * Mean: 50 * Standard Deviation: 10 Interpretation: * Higher scores indicate better cognitive function (i.e., less cognitive interference). * A T-score of 60 means one SD above average (better functioning); a T-score of 40 means one SD below average (more interference) Montreal Cognitive Assessment (MoCA) Scoring: * Total Score Range: 0-30 * Cutoff for Normal Cognition: ≥26 Interpretation: * Higher scores indicate better memory and cognitive function. * Scores between 22-25 suggest mild cognitive impairment (MCI). * Scores below 22 may indicate more significant memory or cognitive issues |
Countries
United States
Contacts
Primary ContactJulia Witkowski
Backup ContactAna Maria Lopez, MD
Outcome results
None listed