Assessing the Time Demands of Cancer

September 2, 2025 updated by: Masonic Cancer Center, University of Minnesota

Time Toxicity of Cancer: the Time Demands of Cancer-related Activities and Their Impact on Well-being and Quality of Life

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center - University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals currently undergoing treatment for metastatic breast or advanced stage ovarian cancer.

Description

Inclusion Criteria:

  • 18 years of age or older
  • Diagnosed with advanced stage (III, IV) ovarian (ovarian, fallopian tube or primary 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Spent on Cancer-related Care Tasks at Home
Time Frame: 28 days
Summary of mobile app smartphone collected data from daily surveys about time spent at home on cancer-related care tasks over 28 days, including taking medications, scheduling appointments, handling medical bills, managing symptoms, monitoring health status and arranging help/transportation.
28 days
Time Spent on All Cancer-related Care Tasks (Out-of-home and at Home)
Time Frame: 28 days
Summary of mobile app smartphone collected data from daily trips and surveys about time spent at home on cancer-related care tasks over 28 days, including out-of-home healthcare encounters, travel time, and at-home tasks including taking medications, scheduling appointments, handling medical bills, managing symptoms, monitoring health status and arranging help/transportation.
28 days
Out-of-home Cancer-related Healthcare Encounters
Time Frame: 28 days
Summary of mobile app smartphone collected from daily-recorded trips away from home, collected over 28 days, focusing on those denoted as being related to cancer care (e.g. clinic visit, treatment, lab, pharmacy, imaging).
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masonic Cancer Center, University of Minnesota

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2023

Primary Completion (Actual)

September 9, 2024

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022LS100
  • 1R01CA277714-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The following data (for which we will obtain participant consent to share in de-identified form) will be collected as part of the project and will be available for sharing in raw or aggregate form. Specifically, any individual level data will be de-identified before sharing. Demographic data may only be shared at an aggregated level as needed to maintain confidentiality.

  • Survey data (baseline, day 28)
  • Mobile application activity and well-being data

The data will be archived and shared and the University of Minnesota Libraries will serve as the steward of the de-identified, archived dataset from that point forward.

IPD Sharing Time Frame

Data will deposited into the repository as soon as possible but no later than within one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier.

IPD Sharing Access Criteria

The de-identified data will be available to all interested parties. No specific data sharing agreement will be needed for DRUM; however, DRUM does have a general end-user access policy available online.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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