CancerNCT06322992
App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic Toxicity in Cancer Patients - Aim 3
An observational study of Cancer, run by Daynamica, Inc. at 1 site in United States.
Trial summary
The goal of this observational study is to develop a mobile app for cancer patients undergoing treatments. In Aim 3, patients will rate the quality of the app using the Mobile App Rating Scale (MARS) and their satisfaction with the three key app features. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2024to 20 Oct 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 60 diverse cancer patients, oversampling socio- economically disadvantaged populations
Who may be able to join
- cancer patients undergoing treatments
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to develop a mobile app for cancer patients undergoing treatments. In Aim 3, patients will rate the quality of the app using the Mobile App Rating Scale (MARS) and their satisfaction with the three key app features. The outcome of this project will be a final prototype app with 70% of patients indicating an overall MARS score of 4.0 or more and satisfaction with the three features.
Read the detailed description
Each year, more than 1.7 million new cancer patients in the U.S. undergo intense, multimodal treatments that that create numerous logistical challenges in managing treatment and everyday life priorities. In the current cancer care system, "logistic toxicity"-the toxic effects imposed by the logistical burden of carrying out cancer treatment-related tasks on patient well-being-has been largely unmeasured and unaddressed. Current methods for measuring logistic toxicity generate retrospective assessments intended for researchers. They do not offer timely information that empower patients to solicit assistance from care providers, employers, family, and friends. Nor do they empower providers to explore the increasingly available treatment options for patient- centered cancer care. This proposal aims to apply a new method-app-assisted day reconstruction-to develop the first digital health tool to enable remote patient monitoring of logistic toxicity, which is the necessary first step towards developing effective care interventions for addressing it.
Our product is both conceptually and technically innovative. Conceptually, the investigators apply the day reconstruction method-a method initially created by well-being researchers for collecting more accurate data on daily life experiences-to collect activity engagement and well-being information related to cancer treatment tasks. Technically, the investigators leverage the existing patented technology and new machine learning techniques to enable novel integration of objective mobile sensing with subjective patient input. Mobile sensing and machine learning will constitute the "assist" that the app provides for day reconstruction in relation to logistic toxicity, significantly reducing recall errors and the need for manual input. The "assist" will also prompt patients to provide information such as subjective well-being ratings that are not detectable by mobile sensing or machine learning, generating more accurate and comprehensive measures of logistic toxicity than existing methods.
The project has three specific aims, including (1) an initial system design based upon input from cancer patients and cancer care stakeholders, (2) prototype development and initial tests, and (3) field tests of the app among 60 diverse patients undergoing treatment for cancer. In Aim 3, patients will rate the quality of the app using the Mobile App Rating Scale (MARS) and their satisfaction with the three key app features: 1) the app's ability to capture out-of-home treatment-related activities and trips, 2) the ease of the interface for inputting home-based treatment-related activities and well-being ratings, and 3) the usefulness of the logistic toxicity summary report. The outcome of this project will be a final prototype app with 70% of patients indicating an overall MARS score of 4.0 or more and satisfaction with the three features. In Phase II, the team will test the efficacy of the app-both separately and in conjunction with care coordination, telemedicine, and home-based treatments-in reducing logistic toxicity and improving treatment outcomes in a randomized controlled trial.
- Conditions
- Cancer
- Keywords
- Logistic Toxicity, Time Toxicity
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Patients Undergoing Treatment | The investigators will recruit 60 diverse cancer patients from the statewide M Health Fairview system to participate in month-long feasibility tests. The enrolled participants will be asked to: 1) Install the prototype app from the Google Play or Apple App Store on their smartphone (the investigators will provide a smartphone with the app pre-installed to participants who do not own one); 2) Carry the smartphone for 30 consecutive days while outside the home; 3) Keep smartphone location and motion services active; 4) Confirm and correct (if needed) smartphone-detected activities and trips; 5) Use the app interface to provide additional information on treatment-related activities and trips along with well-being ratings; and 6) Review a logistic toxicity summary report that will be available within the app towards the end of the field test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
APP satisfaction
The investigators will recruit 60 diverse cancer patients, oversampling socio- economically disadvantaged populations, to conduct month-long usability tests followed by exit surveys. Patients will rate satisfaction with the three app features developed in Aim 2 using the 5-point Likert scale. The Aim 3 milestone will be 70% of patients indicating satisfied/very satisfied with each of the three features.
Measured: March 2024 - May 2025
APP rating
The investigators will recruit 60 diverse cancer patients, oversampling socio- economically disadvantaged populations, to conduct month-long usability tests followed by exit surveys. Patients will rate the overall app quality using the Mobile App Rating Scale (MARS) that encompasses engagement, functionality, aesthetics, information, and subjective quality. The Aim 3 milestone will be an overall MARS score of 4.0 or above.
Measured: March 2024 - May 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start14 May 2024
- Primary completion20 Oct 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 62 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Daynamica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Masonic Cancer Center, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Yingling Fan, Principal investigator, Daynamica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322992
- Sponsor's protocol ID
- R41CA271962
- Status last verified
- May 2024
- First submitted
- 13 Mar 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boyle SJ, Parsons HM, Kyle MA, Jewett P, Yang G, Huang Z, Gupta A, Teoh D, Fan Y, Blaes A, Arend R, Rocque GB, Wolfson J, Vogel RI. Administrative Workload and Associated Distress in Individuals Undergoing Cancer Therapy. Cancer Med. 2026 Nov;15(11):e72416. doi: 10.1002/cam4.72416.
PubMed 42928651
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. 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 - Aim 3
- ClinicalTrials.gov ID
- NCT06322992
- Acronym / sponsor ID
- R41CA271962
- Conditions
- Cancer
- Keywords
- Logistic Toxicity, Time Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Daynamica, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Masonic Cancer Center, University of Minnesota
- Study start
- 14 May 2024 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to develop a mobile app for cancer patients undergoing treatments. In Aim 3, patients will rate the quality of the app using the Mobile App Rating Scale (MARS) and their satisfaction with the three key app features. The outcome of this project will be a final prototype app with 70% of patients indicating an overall MARS score of 4.0 or more and satisfaction with the three features.
Detailed description
Each year, more than 1.7 million new cancer patients in the U.S. undergo intense, multimodal treatments that that create numerous logistical challenges in managing treatment and everyday life priorities. In the current cancer care system, "logistic toxicity"-the toxic effects imposed by the logistical burden of carrying out cancer treatment-related tasks on patient well-being-has been largely unmeasured and unaddressed. Current methods for measuring logistic toxicity generate retrospective assessments intended for researchers. They do not offer timely information that empower patients to solicit assistance from care providers, employers, family, and friends. Nor do they empower providers to explore the increasingly available treatment options for patient- centered cancer care. This proposal aims to apply a new method-app-assisted day reconstruction-to develop the first digital health tool to enable remote patient monitoring of logistic toxicity, which is the necessary first step towards developing effective care interventions for addressing it.
Our product is both conceptually and technically innovative. Conceptually, the investigators apply the day reconstruction method-a method initially created by well-being researchers for collecting more accurate data on daily life experiences-to collect activity engagement and well-being information related to cancer treatment tasks. Technically, the investigators leverage the existing patented technology and new machine learning techniques to enable novel integration of objective mobile sensing with subjective patient input. Mobile sensing and machine learning will constitute the "assist" that the app provides for day reconstruction in relation to logistic toxicity, significantly reducing recall errors and the need for manual input. The "assist" will also prompt patients to provide information such as subjective well-being ratings that are not detectable by mobile sensing or machine learning, generating more accurate and comprehensive measures of logistic toxicity than existing methods.
The project has three specific aims, including (1) an initial system design based upon input from cancer patients and cancer care stakeholders, (2) prototype development and initial tests, and (3) field tests of the app among 60 diverse patients undergoing treatment for cancer. In Aim 3, patients will rate the quality of the app using the Mobile App Rating Scale (MARS) and their satisfaction with the three key app features: 1) the app's ability to capture out-of-home treatment-related activities and trips, 2) the ease of the interface for inputting home-based treatment-related activities and well-being ratings, and 3) the usefulness of the logistic toxicity summary report. The outcome of this project will be a final prototype app with 70% of patients indicating an overall MARS score of 4.0 or more and satisfaction with the three features. In Phase II, the team will test the efficacy of the app-both separately and in conjunction with care coordination, telemedicine, and home-based treatments-in reducing logistic toxicity and improving treatment outcomes in a randomized controlled trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Patients Undergoing Treatment | – | –The investigators will recruit 60 diverse cancer patients from the statewide M Health Fairview system to participate in month-long feasibility tests. The enrolled participants will be asked to: 1) Install the prototype app from the Google Play or Apple App Store on their smartphone (the investigators will provide a smartphone with the app pre-installed to participants who do not own one); 2) Carry the smartphone for 30 consecutive days while outside the home; 3) Keep smartphone location and motion services active; 4) Confirm and correct (if needed) smartphone-detected activities and trips; 5) Use the app interface to provide additional information on treatment-related activities and trips along with well-being ratings; and 6) Review a logistic toxicity summary report that will be available within the app towards the end of the field test. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 60 diverse cancer patients, oversampling socio- economically disadvantaged populations
Key inclusion criteria (1 listed)
- cancer patients undergoing treatments
Key exclusion criteria (1 listed)
- NA
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
APP satisfaction
Time frame: March 2024 - May 2025
The investigators will recruit 60 diverse cancer patients, oversampling socio- economically disadvantaged populations, to conduct month-long usability tests followed by exit surveys. Patients will rate satisfaction with the three app features developed in Aim 2 using the 5-point Likert scale. The Aim 3 milestone will be 70% of patients indicating satisfied/very satisfied with each of the three features.
APP rating
Time frame: March 2024 - May 2025
The investigators will recruit 60 diverse cancer patients, oversampling socio- economically disadvantaged populations, to conduct month-long usability tests followed by exit surveys. Patients will rate the overall app quality using the Mobile App Rating Scale (MARS) that encompasses engagement, functionality, aesthetics, information, and subjective quality. The Aim 3 milestone will be an overall MARS score of 4.0 or above.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Derived from this study: PubMed 42928651Boyle SJ, Parsons HM, Kyle MA, Jewett P, Yang G, Huang Z, Gupta A, Teoh D, Fan Y, Blaes A, Arend R, Rocque GB, Wolfson J, Vogel RI. Administrative Workload and Associated Distress in Individuals Undergoing Cancer Therapy. Cancer Med. 2026 Nov;15(11):e72416. doi: 10.1002/cam4.72416.
- Individual participant dataSharing planned: No
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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.
Yingling Fan principal investigator
Daynamica, Inc.
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 Daynamica, Inc. 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 5 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
APP satisfaction (time frame: March 2024 - May 2025). 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?
On the ClinicalTrials.gov record for NCT06322992, which also lists 1 linked publication.
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 5 Feb 2025.