Surviving Daily Life
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age40+
SponsorThomas Jefferson University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Under 40
Cannot provide informed consent
Trial population
Breast cancer survivor who self-identifies as White, Black/African American, Latina, or Asian
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Mobile Daily Diary
BehavioralThis 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Mobile Daily Diary Survey1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Daily, from Day 2 through Day 15Secondary outcomes
1
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.
Time frame
Daily, from Day 2 through Day 152
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.
Time frame
Twice Daily, from Day 2 through Day 153
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.
Time frame
Twice Daily, from Day 2 through Day 154
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: * 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
Time frame
Daily, from Day 2 through Day 15Sponsors and contacts
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Source ClinicalTrials.gov