Effect of Pre-operative Virtual Visits on Patients With Head and Neck Cancer Undergoing Surgery

NCT06094621 | Withdrawn

• 2 other identifiers: UMCC 2023.067HUM00236077
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  at time of enrollment

Secondary Outcomes (2)

• Comparison in hospitalization between cohorts

  up to 60 days after the surgical resection

• Comparison in post-operative communication

  up to 60 days after the surgical resection

Study Arms (2)

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.

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

Interventions

Survey OTHER

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.

Pre-operative Visit Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Keith Casper

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: March 1, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share