Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
National Cancer Institute (NCI)
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, currently receiving treatment for cancer, able to read/write/speak in English, and able to provide voluntary informed consent.
Exclusion criteria
* Those who are currently incarcerated or have opted out of research contact within M Health Fairview system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interviews | 7 months | 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. |
| Satisfaction Score Follow-Up Survey | 7 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cancer Patients Patients will supply examples of logistic toxicity and how they would like to measure and communicate logistic toxicity across scenarios. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 6 |
Baseline characteristics
| Characteristic | Cancer Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
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.
Time frame: 7 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cancer Patients | Interviews | 20 Interviews |
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.
Time frame: 7 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cancer Patients | Satisfaction Score Follow-Up Survey | 80 Percentage of participants |