CClinicalTrials.gg
RecruitingNCT07848841Updated Sep 30, 2026

Online Perioperative Education Program on Patient Satisfaction and Clinical Outcomes for Head and Neck Surgery

An interventional study of CareOrbit and Standard perioperative education in Head and Neck Cancer (H&N) and Cancer of the Head and Neck, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Otolaryngology
  • Surgery
  • Oncology
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 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

Exclusion criteria

Exclusion Criteria:

  • Younger than 18 years of age
  • No internet access
  • Non-English speaking
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Control Group: Standard perioperative education

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

    Other: Standard perioperative education

  • Experimental
    Intervention Group: Standard perioperative education + CareOrbit access

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

    Other: CareOrbit · Other: Standard perioperative education

Interventions

  • OtherCareOrbit

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

  • OtherStandard perioperative education

    Standard of care perioperative education materials

05

What researchers measure

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.

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

Secondary outcomes

  1. Number of hospital readmissions

    Time frame: At 30 days and 6 months following discharge

  2. Number of operating room takebacks

    Time frame: At 30 days and 6 months following discharge

  3. Number of emergency department visits

    Time frame: At 30 days and 6 months following discharge

  4. Number of staff communications (calls/messages)

    Time frame: At 30 days and 6 months following discharge

  5. Number of unscheduled clinic visits

    Time frame: At 30 days and 6 months following discharge

  6. Number of missed appointments

    Time frame: At 30 days and 6 months following discharge

06

Study locations

1 of 1 sites recruiting
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
    • Jason Rich, MD, FACS · Contact · richj@wustl.edu · 314-747-3742
    • Jason Rich, MD, FACS · Principal investigator
    Recruiting
07

References and documents

08

Registry details

Key details

Study ID
NCT07848841
Lead sponsor
Washington University School of Medicine
Collaborators
The Foundation for Barnes-Jewish Hospital
Responsible party
Sponsor
First posted
Sep 30, 2026
Start date
Sep 23, 2026
Primary completion
Mar 31, 2028 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Sep 30, 2026

Study contacts

Jason Rich, MD, FACS
Contact
richj@wustl.edu
314-747-3742
Jason Rich, MD, FACS
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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