StressGOCENCT07054723
Surviving Daily Life
An observational study of Stress and Cognitive Change, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Stress, Cognitive Change, Breast Cancer
- What is being tested?
- Mobile Daily Diary
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2025to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer survivor who self-identifies as White, Black/African American, Latina, or Asian
Who may be able to join
- 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
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Under 40
- Cannot provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Ana María López, MD, MPH, 215-955-8874, AnaMaria.Lopez@jefferson.edu
About this study
Official title: Daily Stress Process and Daily Cognitive Performance Among Racially Diverse Breast Cancer Survivors: A Feasibility and Validation Study
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.
Read the 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.
- Conditions
- Stress, Cognitive Change, Breast Cancer, Breast Carcinoma, Breast Neoplasm, Cognitive Dysfunction
- Being tested
- Mobile Daily Diary
- Keywords
- Mobile Survey, Daily Diary, Breast Cancer Survivors
- Medical subject headings
- Breast Neoplasms, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Daily DiaryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mobile Daily Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Daily, from Day 2 through Day 15
Secondary outcomes (4)
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.
Measured: Daily, from Day 2 through Day 15
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.
Measured: 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.
Measured: 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:
- 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
Measured: Daily, from Day 2 through Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start2 Oct 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Maria Lopez, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054723
- Sponsor's protocol ID
- iRISID-2025-0027
- Other IDs
- JT 44399
- Acronym
- GOCE
- Status last verified
- Oct 2025
- First submitted
- 27 Jun 2025
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Stress Process and Daily Cognitive Performance Among Racially Diverse Breast Cancer Survivors: A Feasibility and Validation Study
- ClinicalTrials.gov ID
- NCT07054723
- Acronym / sponsor ID
- GOCE / iRISID-2025-0027
- Conditions
- Stress, Cognitive Change, Breast Cancer, Breast Carcinoma, Breast Neoplasm, Cognitive Dysfunction
- Keywords
- Mobile Survey, Daily Diary, Breast Cancer Survivors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Daily Diary Survey | – | Behavioral: Mobile Daily DiaryParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer survivor who self-identifies as White, Black/African American, Latina, or Asian
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Under 40
- Cannot provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Daily DiaryThis 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. | Behavioural | Mobile Daily Diary Survey |
Primary outcome
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
4 secondary outcomes
predictive validity of the Daily Inventory of Stressful Experiences (DISE)
Time frame: Daily, from Day 2 through Day 15
predictive validity of Ambulatory Cognitive Assessment measures
Time frame: Twice Daily, from Day 2 through Day 15
internal reliability of Ambulatory Cognitive Assessment measures
Time frame: Twice Daily, from Day 2 through Day 15
internal reliability of Cognitive Interference and Memory Lapses scale
Time frame: Daily, from Day 2 through Day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana Maria Lopez, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress and Cognitive Change, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Witkowski (215-982-0009, Julia.Witkowski@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate of the 14-day mobile daily diary survey (time frame: Daily, from Day 2 through Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.