Head and Neck Cancer (H&N)NCT07848841
Online Perioperative Education Program on Patient Satisfaction and Clinical Outcomes for Head and Neck Surgery
A study testing CareOrbit and Standard perioperative education in people with Head and Neck Cancer (H&N) and Cancer of the Head and Neck, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer (H&N), Cancer of the Head and Neck
- What is being tested?
- CareOrbit and Standard perioperative education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2026to 31 Mar 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Younger than 18 years of age
- No internet access
- Non-English speaking
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, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Jason Rich, MD, FACS, 314-747-3742, richj@wustl.edu
Jason Rich, MD, FACS
About this study
Official title: Impact of Online Perioperative Education Program on Patient Satisfaction and Clinical Outcomes for Head and Neck Surgery
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.
- Being tested
- CareOrbit, Standard perioperative education
- Keywords
- Otolaryngology, Surgery, Oncology
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareOrbitOther
CareOrbit is a digital perioperative patient-education and care navigation platform .
Standard perioperative educationOther
Standard of care perioperative education materials
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Standard perioperative education | Active comparator | The control group will receive standard perioperative education without access to CareOrbit. Receives: 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. Receives: Other: CareOrbit; Other: Standard perioperative education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 30 days postoperative clinic visit, and at a 3-6 months postoperative clinic visit
Secondary outcomes (6)
Number of hospital readmissions
Measured: At 30 days and 6 months following discharge
Number of operating room takebacks
Measured: At 30 days and 6 months following discharge
Number of emergency department visits
Measured: At 30 days and 6 months following discharge
Number of staff communications (calls/messages)
Measured: At 30 days and 6 months following discharge
Number of unscheduled clinic visits
Measured: At 30 days and 6 months following discharge
Number of missed appointments
Measured: At 30 days and 6 months following discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start23 Sep 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer (H&N)Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Jason Rich, MD, FACS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848841
- Sponsor's protocol ID
- 202607231
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Online Perioperative Education Program on Patient Satisfaction and Clinical Outcomes for Head and Neck Surgery
- ClinicalTrials.gov ID
- NCT07848841
- Acronym / sponsor ID
- 202607231
- Keywords
- Otolaryngology, Surgery, Oncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 30 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: Standard perioperative education | Active comparator | Other: Standard perioperative educationThe control group will receive standard perioperative education without access to CareOrbit. |
| Intervention Group: Standard perioperative education + CareOrbit access | Experimental | Other: CareOrbit, Other: Standard perioperative educationThe intervention group will receive standard perioperative education supplemented by access to the CareOrbit digital platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Younger than 18 years of age
- No internet access
- Non-English speaking
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 |
|---|---|---|
| CareOrbitCareOrbit is a digital perioperative patient-education and care navigation platform . | Other | Intervention Group: Standard perioperative education + CareOrbit access |
| Standard perioperative educationStandard of care perioperative education materials | Other | Control Group: Standard perioperative education, Intervention Group: Standard perioperative education + CareOrbit access |
Primary outcome
Change in ORTC QLQ-INFO25 Satisfaction Score
Time frame: Baseline, 30 days postoperative clinic visit, and at a 3-6 months postoperative clinic visit
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.
6 secondary outcomes
Number of hospital readmissions
Time frame: At 30 days and 6 months following discharge
Number of operating room takebacks
Time frame: At 30 days and 6 months following discharge
Number of emergency department visits
Time frame: At 30 days and 6 months following discharge
Number of staff communications (calls/messages)
Time frame: At 30 days and 6 months following discharge
Number of unscheduled clinic visits
Time frame: At 30 days and 6 months following discharge
Number of missed appointments
Time frame: At 30 days and 6 months following discharge
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 30 Sep 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jason Rich, MD, FACS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CareOrbit and Standard perioperative education in people with Head and Neck Cancer (H&N) and Cancer of the Head and Neck, run by Washington University School of Medicine 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 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 Jason Rich, MD, FACS (314-747-3742, richj@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ORTC QLQ-INFO25 Satisfaction Score (time frame: Baseline, 30 days postoperative clinic visit, and at a 3-6 months postoperative clinic visit). 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 30 Sep 2026.