CancerNCT07810400
A Study Of Remote Patient Monitoring (RPM) Program For Cancer Patients Initiating Cancer-directed Therapy
A study testing Smart Phone Application-based Intervention - SHIELD, AION TempShield and Questionnaires in people with Cancer and Lymphoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial develops and studies whether using a new remote patient monitoring (RPM) program [Smart Health Integration for Early Life-saving Detection (SHIELD)] in cancer practices helps manage infectious complications among cancer patients who are initiating systemic therapy. Read more about this study
- Who is it for?
- Ages 1 year and older
- What is being tested?
- Smart Phone Application-based Intervention - SHIELD, AION TempShield and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2026to 30 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient Inclusion Criteria, Aim 1:
- Documented history of cancer
- Actively receiving cancer care at any Mayo Clinic Midwest practice site
- Involved in or impacted by the care or participation of eligible patients
- Patient Inclusion Criteria, Aim 2
- Documented diagnosis of cancer
Show all 14Show fewer
- ≥ 1 year of age as the CTM device only supports these ages
- Initiating systemic cancer-directed treatment at a Mayo Clinic Midwest site
- Able to read and speak English or Spanish (or have a caregiver capable of either) as the current technologies only support those languages
- Caregiver Inclusion Criteria
- Age 18 years or older.
- Identified as the eligible minor pediatric patient's parent or legal guardian
- Healthcare Professional Inclusion Criteria
- A hematology/oncology clinical, research, RPM, operational, administrative, managerial, or technical/electronic health record (EHR) or other healthcare professional supporting or supervising, or directly affected by the SHIELD program development and pilot implementation study at a participating Mayo Clinic Health System site or Mayo Clinic in Rochester work unit.
Who cannot join
- Patient Exclusion Criteria:
- History of hematopoietic cell transplant or adoptive cellular or bispecific antibody therapy [i.e., chimeric antigen receptor (CAR) T-cell (CAR-T)] within the prior 100 days
- Enrolled in hospice or expected life span < 6 months
- Caregiver and Healthcare Professional Exclusion Criteria
- Unable or unwilling to provide consent to participate in study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Tufia C. Haddad, MD
About this study
Official title: Development And Pilot Implementation Of A Novel Remote Patient Monitoring Program For Cancer Patients Initiating Cancer-directed Therapy: The SHIELD (Smart Health Integration For Early Life-saving Detection)
This clinical trial develops and studies whether using a new remote patient monitoring (RPM) program [Smart Health Integration for Early Life-saving Detection (SHIELD)] in cancer practices helps manage infectious complications among cancer patients who are initiating systemic therapy. Infectious complications are among the most common, costly, and clinically consequential side effects experienced by patients receiving cancer-directed therapy and can lead to increased emergency department evaluations, reduced quality of life, and death. National guidelines support using management strategies within cancer practices for selected patients with infectious complications; however, implementation remains limited by the need for reliable monitoring programs while the patient is at home. The SHIELD program combines remote electronic patient-reported outcome symptom assessments with continuous temperature monitoring (CTM). Patients complete electronic patient-reported outcome symptom assessments on a mobile application and wear a CTM device. Patient responses and CTM data are integrated into the electronic health record, which can create alerts. Cancer practice clinical assistants and nurses review the alerts and create care escalation pathways to the clinical care team or emergency department if needed. The application can also deliver patient education and guidance for self-management of low-grade symptoms. Using the SHIELD program in cancer practices may be an effective way to help manage infectious complications among cancer patients who are initiating systemic therapy.
- Being tested
- Smart Phone Application-based Intervention - SHIELD, AION TempShield, Questionnaires
- Medical subject headings
- Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Phone Application-based Intervention - SHIELDBehavioural
Also called SHIELD, Smart Health Integration for Early Life-saving Detection
Smart Health Integration for Early Life-saving Detection (SHIELD) program used as an electronic patient-reported outcomes (ePRO) and continuous temperature monitoring (CTM)-integrated remote patient monitoring (RPM) care delivery model
AION TempShieldOther
Also called TempShield
Participants will wear the TempShield device by AION an FDA-approved, medical grade continuous temperature monitoring (CTM) wearable sensor
QuestionnairesOther
Also called Surveys
Patients complete questionnaires and study surveys
| Study group | Role | What they receive |
|---|---|---|
| Interview and group discussion (Aim 1) | No intervention | Prior to program/intervention implementation, interviews and group discussions will be held with patients, caregivers, and hematology/oncology professional staff to determine who will benefit from SHIELD, whether the intended population can be reached, and whether SHIELD is perceived as appropriate for the patient population. |
| Aim 2 (SHIELD program) | Experimental | Patients participate in the refined SHIELD program over 90 days and complete ePRO symptom assessments and wear a medical grade CTM device. Patients may also receive care escalation to clinical care team or emergency services as needed as well as patient education and guidance for self-management of low-grade symptoms on study. Receives: Behavioral: Smart Phone Application-based Intervention - SHIELD; Other: AION TempShield; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach - screening eligibility
Screening eligibility rates will be assessed by the percentage of eligible patients screened for study participation.
Measured: Baseline
Reach - enrollment rates
Enrollment rates will be assessed by the percentage of screened patients who enroll in the study.
Measured: Baseline
Reach - representativeness of enrollment
Representativeness of enrollment will be assessed by comparison of urban-rural residence / Rural-Urban Commuting Area (RUCA) codes recorded for participants
Measured: Baseline
Acceptability - PRISM PCSI Staff Survey
The Practical Robust Implementation and Sustainability (PRISM) Contextual Survey Instrument (PCSI) staff survey consists of one question ascertaining the staff role and 29 questions related to perspectives, sustainability, and organizational characteristics of implementing the SHIELD remote patient monitoring program. Questions are answered on a 5-point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree). Results will be analyzed and reported descriptively.
Measured: Baseline
Usability - Remote Patient Monitoring (RPM) Patient/Caregiver Survey
The Remote Patient Monitoring (RPM) survey consists of 17 questions answered on a 5-point scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) and two open-ended questions related to what impressed and what disappointed about the RPM program. Results will be analyzed and reported descriptively.
Measured: 90 days
Enrollment fidelity
Assessed by staff-reported reasons for screening not being completed. Results will be analyzed and reported descriptively.
Measured: Baseline
Intervention fidelity
Assessed by documentation of intervention delivery - delivered as intended or reasons recorded for adaptation of intervention. Results will be analyzed and reported descriptively.
Measured: 90 days
Feasibility - treatment adherence
Assessed by the percent overall of electronic patient-reported outcome (ePRO) assessments completed.
Measured: 90 days
Feasibility - symptoms recorded
Assessed by the percent overall of complete symptom data transmitted
Measured: 90 days
Secondary outcomes (1)
Penetration - enrollment
Assessed by the proportion of sites and individual work units who enroll patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start15 Nov 2026 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tufia C. Haddad, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810400
- Sponsor's protocol ID
- 26-008945
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development And Pilot Implementation Of A Novel Remote Patient Monitoring Program For Cancer Patients Initiating Cancer-directed Therapy: The SHIELD (Smart Health Integration For Early Life-saving Detection)
- ClinicalTrials.gov ID
- NCT07810400
- Acronym / sponsor ID
- 26-008945
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 9 Sep 2026 (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.
This clinical trial develops and studies whether using a new remote patient monitoring (RPM) program [Smart Health Integration for Early Life-saving Detection (SHIELD)] in cancer practices helps manage infectious complications among cancer patients who are initiating systemic therapy. Infectious complications are among the most common, costly, and clinically consequential side effects experienced by patients receiving cancer-directed therapy and can lead to increased emergency department evaluations, reduced quality of life, and death. National guidelines support using management strategies within cancer practices for selected patients with infectious complications; however, implementation remains limited by the need for reliable monitoring programs while the patient is at home. The SHIELD program combines remote electronic patient-reported outcome symptom assessments with continuous temperature monitoring (CTM). Patients complete electronic patient-reported outcome symptom assessments on a mobile application and wear a CTM device. Patient responses and CTM data are integrated into the electronic health record, which can create alerts. Cancer practice clinical assistants and nurses review the alerts and create care escalation pathways to the clinical care team or emergency department if needed. The application can also deliver patient education and guidance for self-management of low-grade symptoms. Using the SHIELD program in cancer practices may be an effective way to help manage infectious complications among cancer patients who are initiating systemic therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interview and group discussion (Aim 1) | No intervention | –Prior to program/intervention implementation, interviews and group discussions will be held with patients, caregivers, and hematology/oncology professional staff to determine who will benefit from SHIELD, whether the intended population can be reached, and whether SHIELD is perceived as appropriate for the patient population. |
| Aim 2 (SHIELD program) | Experimental | Behavioral: Smart Phone Application-based Intervention - SHIELD, Other: AION TempShield, Other: QuestionnairesPatients participate in the refined SHIELD program over 90 days and complete ePRO symptom assessments and wear a medical grade CTM device. Patients may also receive care escalation to clinical care team or emergency services as needed as well as patient education and guidance for self-management of low-grade symptoms on study. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Documented history of cancer
- Actively receiving cancer care at any Mayo Clinic Midwest practice site
- Involved in or impacted by the care or participation of eligible patients
- Patient Inclusion Criteria, Aim 2
- Documented diagnosis of cancer
Key exclusion criteria (5 listed)
- History of hematopoietic cell transplant or adoptive cellular or bispecific antibody therapy [i.e., chimeric antigen receptor (CAR) T-cell (CAR-T)] within the prior 100 days
- Enrolled in hospice or expected life span < 6 months
- Caregiver and Healthcare Professional Exclusion Criteria
- Unable or unwilling to provide consent to participate in study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Phone Application-based Intervention - SHIELDAlso: SHIELD, Smart Health Integration for Early Life-saving DetectionSmart Health Integration for Early Life-saving Detection (SHIELD) program used as an electronic patient-reported outcomes (ePRO) and continuous temperature monitoring (CTM)-integrated remote patient monitoring (RPM) care delivery model | Behavioural | Aim 2 (SHIELD program) |
| AION TempShieldAlso: TempShieldParticipants will wear the TempShield device by AION an FDA-approved, medical grade continuous temperature monitoring (CTM) wearable sensor | Other | Aim 2 (SHIELD program) |
| QuestionnairesAlso: SurveysPatients complete questionnaires and study surveys | Other | Aim 2 (SHIELD program) |
Primary outcome
Reach - screening eligibility
Time frame: Baseline
Screening eligibility rates will be assessed by the percentage of eligible patients screened for study participation.
Reach - enrollment rates
Time frame: Baseline
Enrollment rates will be assessed by the percentage of screened patients who enroll in the study.
Reach - representativeness of enrollment
Time frame: Baseline
Representativeness of enrollment will be assessed by comparison of urban-rural residence / Rural-Urban Commuting Area (RUCA) codes recorded for participants
Acceptability - PRISM PCSI Staff Survey
Time frame: Baseline
The Practical Robust Implementation and Sustainability (PRISM) Contextual Survey Instrument (PCSI) staff survey consists of one question ascertaining the staff role and 29 questions related to perspectives, sustainability, and organizational characteristics of implementing the SHIELD remote patient monitoring program. Questions are answered on a 5-point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree). Results will be analyzed and reported descriptively.
Usability - Remote Patient Monitoring (RPM) Patient/Caregiver Survey
Time frame: 90 days
The Remote Patient Monitoring (RPM) survey consists of 17 questions answered on a 5-point scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) and two open-ended questions related to what impressed and what disappointed about the RPM program. Results will be analyzed and reported descriptively.
Enrollment fidelity
Time frame: Baseline
Assessed by staff-reported reasons for screening not being completed. Results will be analyzed and reported descriptively.
Intervention fidelity
Time frame: 90 days
Assessed by documentation of intervention delivery - delivered as intended or reasons recorded for adaptation of intervention. Results will be analyzed and reported descriptively.
Feasibility - treatment adherence
Time frame: 90 days
Assessed by the percent overall of electronic patient-reported outcome (ePRO) assessments completed.
Feasibility - symptoms recorded
Time frame: 90 days
Assessed by the percent overall of complete symptom data transmitted
1 secondary outcome
Penetration - enrollment
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Tufia C. Haddad, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Phone Application-based Intervention - SHIELD, AION TempShield and Questionnaires in people with Cancer and Lymphoma, run by Mayo Clinic 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 14 inclusion and 5 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: opening soon, as of the sponsor's last update on 11 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach - screening eligibility (time frame: Baseline). The study lists 9 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 11 Sep 2026.