Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA277714-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 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) | 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 | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Study is for patients with either breast or ovarian cancer.
Not provided
Individuals currently undergoing treatment for metastatic breast or advanced stage ovarian cancer.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rachel Vogel, Ph.D. | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Masonic Cancer Center - University of Minnesota |
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.
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.
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 over 28 days, including taking medications, scheduling appointments, handling medical bills, managing symptoms, monitoring health status and arranging help/transportation. | Posted | Median | Inter-Quartile Range | minutes per week | 28 days |
|
|
1 month
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rachel Vogel | University of Minnesota, Masonic Cancer Center | 612-624-6928 | isak0023@umn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2024 | Aug 5, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 16, 2023 | Aug 5, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | 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 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. | Posted | Median | Inter-Quartile Range | minutes per week | 28 days |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | episodes per month | 28 days |
|
|
|
| 0 |
| 78 |
| 0 |
| 78 |
| 0 |
| 78 |
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |