Head and Neck CancerNCT06094621
Effect of Pre-operative Virtual Visits on Patients With Head and Neck Cancer Undergoing Surgery
An observational study of Head and Neck Cancer, run by University of Michigan Rogel Cancer Center.
Trial summary
Patients with head and neck cancer often undergo complex surgeries requiring significant care post-operatively. This presents considerable psychosocial challenges in addition to their need to physically recover from a large surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Survey
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Participants will be adult patients aged 18 and over who underwent surgical resection for head and neck cancer with free flap reconstruction at the University of Michigan through the Department of Otolaryngology.
Who may be able to join
- Patients > 18 years
- Underwent surgery for head and neck cancer with free flap reconstruction at the University of Michigan
- Underwent a pre-operative virtual visit.
- Patients > 18 years
- Underwent surgery for head and neck cancer with free flap reconstruction at the University of Michigan
Who cannot join
- Patients who died within 60 days of surgery for head and neck cancer with free flap reconstruction at the University of Michigan.
- Patients who died within 60 days of surgery for head and neck cancer with free flap reconstruction at the University of Michigan.
- Patient underwent a pre-operative virtual visit.
About this study
Official title: Effect of Pre-operative Virtual Visits on Care of Patients With Head and Neck Cancer Undergoing Surgery
Patients with head and neck cancer often undergo complex surgeries requiring significant care post-operatively. This presents considerable psychosocial challenges in addition to their need to physically recover from a large surgery.
The study team will interview patients who have undergone virtual visits before their surgical procedures. The study aims to explore patients' experiences, satisfaction, and perceptions of virtual visits for informing and preparing them for surgery and their postoperative care needs.
The study team will also analyze the effects of the virtual visits on financial costs and patient outcomes such as length of hospital stay, delayed discharges due to social issues, and whether the virtual visits identified any significant medical concerns, etc. The study team will compare these to a randomly selected cohort of patients who also underwent surgical resection and reconstruction for head and neck cancer that did not get pre-operative virtual visits.
- Conditions
- Head and Neck Cancer
- Being tested
- Survey
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
For the patients who underwent a pre-operative virtual visit, data will be collected through semi-structured interviews conducted by trained research personnel. The interviews will be conducted in a one-on-one format, either in-person or via telephone, according to the participant's preference.
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative Visit Arm | Eligible participants for the interview and surveys will be those who have undergone a virtual visit by the head and neck surgery nurse practitioners before their scheduled surgical procedure. Receives: Other: Survey | |
| No Pre-operative Visit Arm | Patients who also underwent surgical resection for head and neck cancer with free flap reconstruction at the University of Michigan through the Department of Otolaryngology but did NOT receive a pre-operative virtual visit. This cohort is a retrospective chart review study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of virtual visits as determined by satisfaction scores
To examine the satisfaction scores of patients who undergo pre-operative virtual visits. The satisfaction scale is graded on a modified Likert scale. The endpoint for this primary objective is the score given by the patient on the interview-based survey
Measured: at time of enrollment
Secondary outcomes (2)
Comparison in hospitalization between cohorts
To examine if patients who undergo pre-operative virtual visits have reduced hospital length of stay (i.e. number of days hospitalization post-operatively) compared to patients who did not undergo these visits.
Measured: up to 60 days after the surgical resection
Comparison in post-operative communication
To examine if patients who undergo pre-operative virtual visits have reduced post-operative communication measured in portal messages and phone calls compared to patients who did not undergo these visits.
Measured: up to 60 days after the surgical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study startMar 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: No Investigator Interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Casper, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094621
- Sponsor's protocol ID
- UMCC 2023.067
- Other IDs
- HUM00236077
- Status last verified
- Mar 2025
- First submitted
- 16 Oct 2023
- Last updated
- 7 Mar 2025
- Results posted
- 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 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-operative Virtual Visits on Care of Patients With Head and Neck Cancer Undergoing Surgery
- ClinicalTrials.gov ID
- NCT06094621
- Acronym / sponsor ID
- UMCC 2023.067
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No Investigator Interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 23 Oct 2023 (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.
Patients with head and neck cancer often undergo complex surgeries requiring significant care post-operatively. This presents considerable psychosocial challenges in addition to their need to physically recover from a large surgery.
The study team will interview patients who have undergone virtual visits before their surgical procedures. The study aims to explore patients' experiences, satisfaction, and perceptions of virtual visits for informing and preparing them for surgery and their postoperative care needs.
The study team will also analyze the effects of the virtual visits on financial costs and patient outcomes such as length of hospital stay, delayed discharges due to social issues, and whether the virtual visits identified any significant medical concerns, etc. The study team will compare these to a randomly selected cohort of patients who also underwent surgical resection and reconstruction for head and neck cancer that did not get pre-operative virtual visits.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-operative Visit Arm | – | Other: SurveyEligible participants for the interview and surveys will be those who have undergone a virtual visit by the head and neck surgery nurse practitioners before their scheduled surgical procedure. |
| No Pre-operative Visit Arm | – | –Patients who also underwent surgical resection for head and neck cancer with free flap reconstruction at the University of Michigan through the Department of Otolaryngology but did NOT receive a pre-operative virtual visit. This cohort is a retrospective chart review study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be adult patients aged 18 and over who underwent surgical resection for head and neck cancer with free flap reconstruction at the University of Michigan through the Department of Otolaryngology.
Key inclusion criteria (5 listed)
- Patients > 18 years
- Underwent surgery for head and neck cancer with free flap reconstruction at the University of Michigan
- Underwent a pre-operative virtual visit.
- Patients > 18 years
- Underwent surgery for head and neck cancer with free flap reconstruction at the University of Michigan
Key exclusion criteria (3 listed)
- Patients who died within 60 days of surgery for head and neck cancer with free flap reconstruction at the University of Michigan.
- Patients who died within 60 days of surgery for head and neck cancer with free flap reconstruction at the University of Michigan.
- Patient underwent a pre-operative virtual visit.
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 |
|---|---|---|
| SurveyFor the patients who underwent a pre-operative virtual visit, data will be collected through semi-structured interviews conducted by trained research personnel. The interviews will be conducted in a one-on-one format, either in-person or via telephone, according to the participant's preference. | Other | Pre-operative Visit Arm |
Primary outcome
Effectiveness of virtual visits as determined by satisfaction scores
Time frame: at time of enrollment
To examine the satisfaction scores of patients who undergo pre-operative virtual visits. The satisfaction scale is graded on a modified Likert scale. The endpoint for this primary objective is the score given by the patient on the interview-based survey
2 secondary outcomes
Comparison in hospitalization between cohorts
Time frame: up to 60 days after the surgical resection
Comparison in post-operative communication
Time frame: up to 60 days after the surgical resection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- 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. This study is not recruiting at the moment.
Keith Casper principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by University of Michigan Rogel Cancer Center.
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: withdrawn, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of virtual visits as determined by satisfaction scores (time frame: at time of enrollment). 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 7 Mar 2025.