Metastatic Breast CancerNCT05708703
Assessing the Time Demands of Cancer
An observational study of Metastatic Breast Cancer and Ovarian Cancer, run by Masonic Cancer Center, University of Minnesota at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Ovarian Cancer
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Nov 2023to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals currently undergoing treatment for metastatic breast or advanced stage ovarian cancer.
Who may be able to join
- 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
Who cannot join
- Those who are currently incarcerated
- Have opted out of research contact
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama
Birmingham, Alabama, 35294
Masonic Cancer Center - University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
- Conditions
- Metastatic Breast Cancer, Ovarian Cancer
- Keywords
- ovarian cancer, metastatic breast cancer, time use, quality of life, cancer survivorship
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Time Spent on Cancer-related Care Tasks at Home
Summary of mobile app smartphone collected data from daily surveys about time spent at home on cancer-related care tasks, including taking medications, scheduling appointments, handling medical bills, managing symptoms, monitoring health status and arranging help/transportation. Data collected over 28 days to record average over 28 day period.
Measured: 28 days
Time Spent on All Cancer-related Care Tasks (Out-of-home and at Home)
Summary of mobile app smartphone collected data from daily trips and surveys about time spent at home on cancer-related care tasks, 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. Data collected over 28 days to record average over 28 day period.
Measured: 28 days
Out-of-home Cancer-related Healthcare Encounters
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).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start13 Nov 2023
- Primary completion9 Sep 2024
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Rachel Vogel, Ph.D., Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708703
- Sponsor's protocol ID
- 2022LS100
- Other IDs
- 1R01CA277714-01
- Status last verified
- Sep 2026
- First submitted
- 20 Jan 2023
- Last updated
- 30 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Boyle SJ, Parsons HM, Kyle MA, Jewett P, Yang G, Huang Z, Gupta A, Teoh D, Fan Y, Blaes A, Arend R, Rocque GB, Wolfson J, Vogel RI. Administrative Workload and Associated Distress in Individuals Undergoing Cancer Therapy. Cancer Med. 2026 Nov;15(11):e72416. doi: 10.1002/cam4.72416.
PubMed 42928651
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Toxicity of Cancer: the Time Demands of Cancer-related Activities and Their Impact on Well-being and Quality of Life
- ClinicalTrials.gov ID
- NCT05708703
- Acronym / sponsor ID
- 2022LS100
- Conditions
- Metastatic Breast Cancer, Ovarian Cancer
- Keywords
- ovarian cancer, metastatic breast cancer, time use, quality of life, cancer survivorship
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Posted 16 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals currently undergoing treatment for metastatic breast or advanced stage ovarian cancer.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Those who are currently incarcerated
- Have opted out of research contact
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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, including taking medications, scheduling appointments, handling medical bills, managing symptoms, monitoring health status and arranging help/transportation. Data collected over 28 days to record average over 28 day period.
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, 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. Data collected over 28 days to record average over 28 day period.
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42928651Boyle SJ, Parsons HM, Kyle MA, Jewett P, Yang G, Huang Z, Gupta A, Teoh D, Fan Y, Blaes A, Arend R, Rocque GB, Wolfson J, Vogel RI. Administrative Workload and Associated Distress in Individuals Undergoing Cancer Therapy. Cancer Med. 2026 Nov;15(11):e72416. doi: 10.1002/cam4.72416.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
Rachel Vogel, Ph.D. principal investigator
Masonic Cancer Center, University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer and Ovarian Cancer, run by Masonic Cancer Center, University of Minnesota at 2 sites 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 6 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 16 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Spent on Cancer-related Care Tasks at Home (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05708703, which also lists 1 linked publication.
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 30 Sep 2026.