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NCT Number: NCT07054723

Surviving Daily Life

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.

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Key information

Age range

40 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location status: Recruiting

Location contact

Ana María López, MD, MPH

CONTACT

[email protected]

215-955-8874

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Completion rate of the 14-day mobile daily diary survey

    Time frame: 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 outcomes

  1. predictive validity of the Daily Inventory of Stressful Experiences (DISE)

    Time frame: 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.

  2. predictive validity of Ambulatory Cognitive Assessment measures

    Time frame: 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.

  3. internal reliability of Ambulatory Cognitive Assessment measures

    Time frame: 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.

  4. internal reliability of Cognitive Interference and Memory Lapses scale

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Maria Lopez, MD

CONTACT

[email protected]

215-503-6413

Julia Witkowski

CONTACT

[email protected]

215-982-0009

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

Daily Stress Process and Daily Cognitive Performance Among Racially Diverse Breast Cancer Survivors: A Feasibility and Validation Study

Acronym: GOCE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2025
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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