Metastatic Breast Cancer, Ovarian Cancer
Conditions
Keywords
ovarian cancer, metastatic breast cancer, time use, quality of life, cancer survivorship
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.
Interventions
None listed
Sponsors
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Masonic Cancer Center, University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent on Cancer-related Care Tasks at Home | 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. |
| Time Spent on All Cancer-related Care Tasks (Out-of-home and at Home) | 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. |
| Out-of-home Cancer-related Healthcare Encounters | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 78 |
| Total | 78 |
Baseline characteristics
| Characteristic | Study Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 23 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 59 Participants |
| Region of Enrollment United States | 78 participants |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 78 |
| other Total, other adverse events | 0 / 78 |
| serious Total, serious adverse events | 0 / 78 |
Outcome results
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).
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Cohort | Out-of-home Cancer-related Healthcare Encounters | 4.9 episodes per month | Standard Deviation 3.1 |
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.
Time frame: 28 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study Cohort | Time Spent on All Cancer-related Care Tasks (Out-of-home and at Home) | 404 minutes per week |
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.
Time frame: 28 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study Cohort | Time Spent on Cancer-related Care Tasks at Home | 196 minutes per week |