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| ID | Type | Description | Link |
|---|---|---|---|
| R41CA271962 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The number of new cases of cancer diagnosed in the U.S. was 1.7 million in 2017 and is expected to increase by 35% to 2.3 million in 2030[1]. Cancer treatments often create numerous logistic challenges in prioritizing and managing treatment and everyday life priorities and how these challenges affect their everyday lives and well-being (hence "logistic toxicity"). However, there are no established reliable tools to monitor patients' logistic challenges and the associated impacts; and logistic toxicity has been largely unaddressed in cancer care delivery. The objective is to develop the first digital health app for cancer patients to continuously monitor logistic toxicity in their daily lives. The app will combine objective data from mobile sensing with subjective self-reported data to form an app-assisted day reconstruction system that captures activity engagement and well-being information associated with cancer treatment-related activities and trips throughout the day.
The proposed patient monitoring app that captures logistic toxicity information on an ongoing basis will empower patients to advocate for care that better fits their life, give providers new insights into potential reasons for treatment non-adherence and nonresponse, and allow health systems to design more patient-centered care regimens.
A participatory design approach will be used to inform the design of our system, performing in-depth interviews and follow-up surveys with 20 diverse patients undergoing treatment for cancer. Patients will supply examples of logistic toxicity and how they would like to measure and communicate logistic toxicity across scenarios. Follow-up surveys will ask participants to provide satisfaction ratings towards user interface sketches and app function narratives.
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| Measure | Description | Time Frame |
|---|---|---|
| Interviews | Number of Interviews completed to help identify themes to develop a cancer-specific, multi-tiered activity/trip classification system to organize cancer treatment-related activities and trips in the app; and user stories to describe what the users want to do with the proposed app. 45-minute interviews. | 7 months |
| Satisfaction Score Follow-Up Survey | Participants with overall satisfaction with proposed system design will be measured using a 5-point Likert scale from not at all satisfied to very satisfied. The primary endpoint will be the proportion of participants who report an overall satisfaction score of 4.0 or above. 10-Minutes. | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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MHealth Fairview Cancer Clinics
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| Name | Affiliation | Role |
|---|---|---|
| Rachel I Vogel, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center - University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cancer Patients | Patients will supply examples of logistic toxicity and how they would like to measure and communicate logistic toxicity across scenarios. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
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| BG000 | Cancer Patients | Patients will supply examples of logistic toxicity and how they would like to measure and communicate logistic toxicity across scenarios. |
| Units | Counts |
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| Participants |
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| 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 | ||||||||
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| Primary | Interviews | Number of Interviews completed to help identify themes to develop a cancer-specific, multi-tiered activity/trip classification system to organize cancer treatment-related activities and trips in the app; and user stories to describe what the users want to do with the proposed app. 45-minute interviews. | Posted | Number | Interviews | 7 months |
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7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cancer Patients | Patients will supply examples of logistic toxicity and how they would like to measure and communicate logistic toxicity across scenarios. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rachel Vogel | University of Minnesota, Masonic Cancer Center | 612-624-6928 | isak0023@umn.edu |
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| 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 | Jan 5, 2023 | May 7, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 22, 2022 | May 7, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Satisfaction Score Follow-Up Survey | Participants with overall satisfaction with proposed system design will be measured using a 5-point Likert scale from not at all satisfied to very satisfied. The primary endpoint will be the proportion of participants who report an overall satisfaction score of 4.0 or above. 10-Minutes. | Posted | Number | Percentage of participants | 7 months |
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