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| ID | Type | Description | Link |
|---|---|---|---|
| JT 44399 | Other Identifier | JeffTrial Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Daily Diary Survey | Participants in the study will be given a mobile phone to complete the study. Participants will first complete 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 a password protected mobile phone which will be set up to ensure that participants are only able to use the phone for the study processes, not for phone calls or to connect to the internet. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Daily Diary | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate of the 14-day mobile daily diary survey | 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 | Daily, from Day 2 through Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| predictive validity of the Daily Inventory of Stressful Experiences (DISE) | 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. | Daily, from Day 2 through Day 15 |
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Inclusion Criteria:
Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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Breast cancer survivor who self-identifies as White, Black/African American, Latina, or Asian
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia Witkowski | Contact | 215-982-0009 | Julia.Witkowski@jefferson.edu | |
| Ana Maria Lopez, MD | Contact | 215-503-6413 | AnaMaria.Lopez@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ana Maria Lopez, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| predictive validity of Ambulatory Cognitive Assessment measures | 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. | Twice Daily, from Day 2 through Day 15 |
| internal reliability of Ambulatory Cognitive Assessment measures | 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. | Twice Daily, from Day 2 through Day 15 |
| internal reliability of Cognitive Interference and Memory Lapses scale | 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:
Interpretation:
Montreal Cognitive Assessment (MoCA) Scoring:
Interpretation:
| Daily, from Day 2 through Day 15 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |