Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Location status: Recruiting
NCT Number: NCT07054723
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.
Interested in participating?
Request Info40 year and older
Female
Observational
Philadelphia, Pennsylvania, 19107, United States
Location status: Recruiting
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.
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:
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
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.
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
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.
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.
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.
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:
Interpretation:
Montreal Cognitive Assessment (MoCA)
Scoring:
Interpretation:
Contact information is provided by the study sponsor or research team.
Ana Maria Lopez, MD
CONTACT
Julia Witkowski
CONTACT
Thomas Jefferson University
Other
Daily Stress Process and Daily Cognitive Performance Among Racially Diverse Breast Cancer Survivors: A Feasibility and Validation Study
Acronym: GOCE
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.
Published trials that share one or more normalized conditions with this study.
NCT06002022
Behavior, Breast Cancer
Valencia, Spain
View Trial DetailsNCT06534957
Breast Cancer, Breast Diseases
San Pedro Garza García, Nuevo León, Mexico
View Trial DetailsNCT05984914
Breast Cancer, Breast Diseases
Athens, Greece
View Trial DetailsNCT04293874
Behavior, Behavior, Animal
Hartford, Connecticut, United States
View Trial Details