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Assessing the Time Demands of Cancer

Sponsor
Masonic Cancer Center, University of Minnesota (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05708703
Collaborator
National Cancer Institute (NCI) (NIH)
80
Enrollment
2
Locations
94.9
Anticipated Duration (Months)
40
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A total of 80 individuals receiving treatment for metastatic breast or advanced stage ovarian cancer will be asked to complete a baseline survey and install the mobile app on their smartphone; carry the smartphone for 28 consecutive days while outside the home; keep smartphone location and motion services active; confirm and correct (if needed) smartphone-detected activities and trips; use the app interface to provide additional information on activities and trips related to cancer treatment tasks; complete daily surveys regarding well-being; and at the end of the 28 day period, complete an online survey.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Time Toxicity of Cancer: the Time Demands of Cancer-related Activities and Their Impact on Well-being and Quality of Life
    Anticipated Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2027
    Anticipated Study Completion Date :
    Dec 31, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    Study cohort

    Individuals receiving treatment for metastatic breast cancer or advanced stage ovarian cancer, will complete a baseline survey, install a mobile app on their smartphone to track daily activities, short daily surveys, and a study end survey

    Outcome Measures

    Primary Outcome Measures

    1. Activity and trip types [28 days]

      Using the mobile app smartphone collected data, compute number of different activity or trip types.

    2. Activity length [28 days]

      Using the mobile app smartphone collected data, compute the number of minutes per day spent on different activities.

    3. Activity reoccurrence [28 days]

      Using the mobile app smartphone collected data, compute separate activity episodes and frequency per week.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years of age or older

    • Diagnosed with advanced stage (III, IV) ovarian (ovarian, fallopian tube or prmary peritoneal) or metastatic breast cancer [do not need to be newly diagnosed]

    • Currently receiving any type of therapy for their cancer [can be front-line, maintenance therapy, or treatment for recurrence]

    • Able to complete study tasks in English

    • Able to provide voluntary informed consent

    • Own an Android or iOS smartphone on which the operating system is version 9.0 or higher for Android or 10.0 higher for iOS; or willing to use a researcher-provided smartphone

    Exclusion Criteria:

    • Those who are currently incarcerated

    • Have opted out of research contact

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama Birmingham Alabama United States 35294
    2 Masonic Cancer Center - University of Minnesota Minneapolis Minnesota United States 55455

    Sponsors and Collaborators

    • Masonic Cancer Center, University of Minnesota
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Rachel Vogel, Ph.D., University of Minnesota Masonic Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Masonic Cancer Center, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT05708703
    Other Study ID Numbers:
    • 2022LS100
    First Posted:
    Feb 1, 2023
    Last Update Posted:
    Feb 1, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Masonic Cancer Center, University of Minnesota
    ovarian cancer
    metastatic breast cancer
    time use
    quality of life
    cancer survivorship
    Additional relevant MeSH terms:
    Ovarian Neoplasms

    Study Results

    No Results Posted as of Feb 1, 2023