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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06094621
• Other study ID #: UMCC 2023.067
• Secondary ID: HUM00236077
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: Cancer AnswerLine
• Phone: 1-800-865-1125
• Email: CancerAnswerLine[@]med.umich.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (Pre-operative Visit Arm)

• 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.

Inclusion Criteria (NO Pre-operative Visit Arm)

• Patients > 18 years

• Underwent surgery for head and neck cancer with free flap reconstruction at the University of Michigan

Exclusion Criteria (Pre-operative Visit Arm)

• Patients who died within 60 days of surgery for head and neck cancer with free flap reconstruction at the University of Michigan.

Exclusion Criteria (NO Pre-operative Visit Arm)

• 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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Survey
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	up to 60 days after the surgical resection
Secondary	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.	up to 60 days after the surgical resection