Health TrialsbyHealthPanel

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

ConditionsHead and Neck Cancer (H&N)Cancer of the Head and Neck
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Younger than 18 years of age

No internet access

Non-English speaking

Trial design

Design model

Parallel

Treatments tested in this trial

  • CareOrbit

    Other intervention

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

  • Standard perioperative education

    Other intervention

    Standard of care perioperative education materials

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Control Group: Standard perioperative educationActive comparator 1 intervention
Group B: Intervention Group: Standard perioperative education + CareOrbit accessExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

The Foundation for Barnes-Jewish Hospital

Collaborator

Source ClinicalTrials.gov
Apply now