Surviving Daily Life

NCT ID: NCT07054723

Last Updated: 2025-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-02

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stress Cognitive Change Breast Cancer Breast Carcinoma Breast Neoplasm Cognitive Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Mobile Daily Diary

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ana Maria Lopez, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

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Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Julia Witkowski

Role: CONTACT

215-982-0009

Ana Maria Lopez, MD

Role: CONTACT

215-503-6413

Facility Contacts

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Ana María López, MD, MPH

Role: primary

215-955-8874

Other Identifiers

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JT 44399

Identifier Type: OTHER

Identifier Source: secondary_id

iRISID-2025-0027

Identifier Type: -

Identifier Source: org_study_id

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