Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06674811

Conditions

Pediatric Cancer

Neuroblastoma

Sarcoma

Wilms Tumor and Other Childhood Kidney Tumors

Childhood Soft Tissue Sarcoma

Eligibility Criteria

Sex: All

Age: 3 - 25

Healthy Volunteers: Not accepted

Interventions

Wearing Smartwatch

Patient Report Outcomes

Blood Draw

Clinical Data Review

Study Details

Brief summary:

This observational study is to better understand how children and their families recover after the stress of major surgery for cancer so that investigators can create ways to improve resilience during recovery. The main questions it aims to answer are:

1. Can information obtained from patients and their caregivers wearing smartwatches and answering questionnaires be used to measure how patients are recovering from surgery?
2. Are there specific patterns in patients' circulating proteins and metabolites that are associated with stress after surgery?

Participants, including pediatric patients undergoing surgery for cancer and their primary caregiver, will be asked to:

  • wear a smartwatch
  • complete questionnaires
  • allow for extra blood to be drawn for this research study when they are having their regular blood draws for clinical purposes

These actions will occur at baseline prior to patients' surgery and then afterwards for up to one year. There are no changes to participants' clinical care or surgical care as a result of the study. Investigators will also collect participants' clinical information and cancer-specific outcomes. Participants will be remunerated for their time.

Conditions

Pediatric Cancer

Neuroblastoma

Sarcoma

Wilms Tumor and Other Childhood Kidney Tumors

Childhood Soft Tissue Sarcoma

Study ID

NCT06674811

Start date

Jan 15, 2025

Status verified date

Sep, 2026

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Jan 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 3-25 years old at enrollment
  • With solid tumors of the chest, abdomen, and extremities including neuroblastic tumors, sarcoma including soft tissue and bone, kidney tumors, liver tumors, ovarian tumors, lung and pleural-based tumors, and intestinal tumors

-OR-

  • Guardian or primary caregiver of patient 3-25 years old with one of the aforementioned tumors.

Exclusion Criteria:

  • Patients who are known to be pregnant or prisoners.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Patient

Children and young adults 3-18 years old who are undergoing surgical resection of an extracranial solid tumor.

Caregiver

Primary caregiver or parent of a a child or young adults 3-18 years old who is undergoing surgical resection for an extracranial solid tumor and has agreed to participate in the study.

Interventions

Wearing Smartwatch

Patients and their caregivers will be asked to start wearing a smartwatch prior to surgery and continuing to wear it for one year following surgery at all times except when bathing or swimming, eating, undergoing a procedure, or if refusing to wear them. The smartwatches collect motor activity by minutes spent being sedentary, active, or highly active, heart rate, and sleep duration and stages. Data from the smartwatches syncs with Garmin connect using Fitabase to allow the study team to review the data.

Patient Report Outcomes

To obtain patient-reported outcomes (PROs), questionnaires will be administered at time of enrollment, in the two weeks prior to surgery if applicable, and at 1, 2, 4, 8, 12, 16, 20, 24, 34, 44, and 54 weeks postoperatively. Questionnaires can be completed electronically, over the telephone or in person. The PedsQL Cancer Module and Patient Health Questionnaire depression scale (PHQ-9) will be utilized for questionnaires.

Blood Draw

When patients are having blood drawn as part of their regular care, extra blood may be drawn for this study. Participants may opt out of this. Blood draws will occur preoperatively and at intervals postoperatively for proteomic, metabolomic, and exposomic testing.

Clinical Data Review

Clinical data will be collected and stored in a database by study staff. This includes patient demographics, diagnosis characteristics including staging and risk group, treatment characteristics, and outcomes including length of stay following surgical intervention, readmissions, surgical complications including surgical site infection, time off therapy/time to resumption of chemotherapy.

Primary outcome measure

  • Surgical resilience [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Mayo Clinic Pediatric Surgery Clinical Research Unit

507-266-4467DOSCRO2@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55901

Contacts

Stephanie F Polites, MD, MPH

507-284-2623polites.stephanie@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • digital biomarker
  • remote monitoring
  • smartwatch
  • surgery
  • pediatric cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.