CancerNCT05502302
App-Assisted Day Reconstruction to Reduce Logistic Toxicity in Cancer
An observational study of Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2022to 28 Feb 2023
- 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: MHealth Fairview Cancer Clinics
Who may be able to join
- 18 years of age, currently receiving treatment for cancer, able to read/write/speak in English, and able to provide voluntary informed consent.
Who cannot join
- Those who are currently incarcerated or have opted out of research contact within M Health Fairview system.
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center - University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic Toxicity in Cancer Patients
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.
Read the 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.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start28 Jul 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
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.
- Other trials for 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rachel I Vogel, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502302
- Sponsor's protocol ID
- 2022LS036
- Other IDs
- R41CA271962
- Status last verified
- Jun 2024
- First submitted
- 12 Aug 2022
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic Toxicity in Cancer Patients
- ClinicalTrials.gov ID
- NCT05502302
- Acronym / sponsor ID
- 2022LS036
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MHealth Fairview Cancer Clinics
Key inclusion criteria (1 listed)
- 18 years of age, currently receiving treatment for cancer, able to read/write/speak in English, and able to provide voluntary informed consent.
Key exclusion criteria (1 listed)
- Those who are currently incarcerated or have opted out of research contact within M Health Fairview system.
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
Interviews
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 I Vogel, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 Jul 2024). 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?
Interviews (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2024.