NCT07848841

Brief Summary

CareOrbit is a digital perioperative patient-education and care navigation platform developed by the St. Louis-based venture Total Orbit in collaboration with Washington University's CORTEX Business Incubator. For head and neck cancer (HNC) care, the platform is designed to address gaps in perioperative education by guiding patients through each stage of their surgical journey using structured modules, step-by-step instructional videos, and centralized educational resources. CareOrbit delivers physician-authored content tailored to an individual's surgical care, including overviews of surgical treatment, preoperative preparation, and expectations for postoperative recovery. Early anecdotal experiences suggest that patients appreciate the accessibility of the tool, but systematic evaluation is lacking in whether use of the tool improves understanding, satisfaction, and care outcomes. This project will address key knowledge gaps by employing a clinical trial to examine key clinical endpoints.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Mar 2028

First Submitted

Initial submission to the registry

September 23, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Head and Neck Cancer (H&N)Cancer of the Head and Neck

Keywords

OtolaryngologySurgeryOncology

Outcome Measures

Primary Outcomes (1)

  • Change in ORTC QLQ-INFO25 Satisfaction Score

    The EORTC QLQ-INFO25 is a 25-item patient-reported questionnaire that assesses the amount and type of information cancer patients receive about their disease, treatment, side effects, support services, and related care. Items are rated on a 4-point scale from 1 = not at all to 4 = very much, with selected yes/no items. The total score is typically reported as 0 to 100. Higher scores indicate that more information was received and, for relevant items, greater satisfaction or perceived helpfulness of the information.

    Baseline, 30 days postoperative clinic visit, and at a 3-6 months postoperative clinic visit

Secondary Outcomes (6)

  • Number of hospital readmissions

    At 30 days and 6 months following discharge

  • Number of operating room takebacks

    At 30 days and 6 months following discharge

  • Number of emergency department visits

    At 30 days and 6 months following discharge

  • Number of staff communications (calls/messages)

    At 30 days and 6 months following discharge

  • Number of unscheduled clinic visits

    At 30 days and 6 months following discharge

  • +1 more secondary outcomes

Study Arms (2)

Control Group: Standard perioperative education

ACTIVE COMPARATOR

The control group will receive standard perioperative education without access to CareOrbit.

Other: Standard perioperative education

Intervention Group: Standard perioperative education + CareOrbit access

EXPERIMENTAL

The intervention group will receive standard perioperative education supplemented by access to the CareOrbit digital platform.

Other: CareOrbitOther: Standard perioperative education

Interventions

CareOrbitOTHER

CareOrbit is a digital perioperative patient-education and care navigation platform .

Intervention Group: Standard perioperative education + CareOrbit access
Standard perioperative educationOTHER

Standard of care perioperative education materials

Control Group: Standard perioperative educationIntervention Group: Standard perioperative education + CareOrbit access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Have a new diagnosis of head and neck cancer
  • Planning or scheduled to undergo free flap surgery and/or total laryngectomy, or caregiver to eligible patients
  • Have internet access
  • English speaking

You may not qualify if:

  • Younger than 18 years of age
  • No internet access
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

Study Officials

  • Jason Rich, MD, FACS

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Rich, MD, FACS

CONTACT

314-747-3742richj@wustl.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2026

First Posted

September 30, 2026

Study Start

September 23, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)