A Randomized Control Trial for Patient Reported Outcomes and Safety in Outpatient Thyroid Lobectomy

NCT06085625 | Recruiting Phase 2

• 2 other identifiers: 2022-0511NCI-2023-08793
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

To compare same-day discharge and overnight (or longer) observation practices and learn more about the differences in patient preferences, safety outcomes, and economic and resource impact

Conditions

Thyroid Lobectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  through study completion; an average of 1 year

Study Arms (1)

Patient Reported Outcomes and Safety in Outpatient Thyroid Lobectomy

EXPERIMENTAL

Participants will first complete a survey about the severity of your symptoms. This will be done at your pre-surgery (pre-operative) visit and should take about 5-10 minutes to complete. Study Groups At your pre-surgery visit, you will be assigned to either be sent home on the same day as surgery or to stay in the hospital overnight (or longer) for observation. This will be determined based on which group your surgeon has been assigned to. Participants will be told which group you are in.

Behavioral: Pre-Surgery Survey; Behavioral: Post-Surgery Surveys

Interventions

Pre-Surgery Survey BEHAVIORAL

Participants will be asked to complete a survey 3 times (before surgery, after surgery, and 2 weeks after surgery). You will be monitored for up to 1 month after your surgery, where you may be contacted by a study provider virtually or in person to ask you about medication usage and heath care needs.

Patient Reported Outcomes and Safety in Outpatient Thyroid Lobectomy

Post-Surgery Surveys BEHAVIORAL

After surgery, Participants will complete the same survey as in the pre-surgery visit about 1 day and then 2 weeks after surgery. These surveys will be completed electronically through the MyChart system. They will take about 5-10 minutes to complete and must be done within 24 hours after receiving the survey. Participants will be monitored for 1 month after your surgery, including your standard-of-care postoperative visit at about 2 weeks. You may be contacted by a provider for a phone or in person visit at the 1-month time point to ask how you are doing.

Patient Reported Outcomes and Safety in Outpatient Thyroid Lobectomy

Eligibility Criteria

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

You may qualify if:

• Patients ≥18 years of age
• Patients undergoing initial partial or complete thyroid lobectomy
• English and non-English speaking patients are eligible

You may not qualify if:

• Increased risk of bleeding (e.g., Aspirin, antiplatelet therapy, or anticoagulation that cannot be held 5 days before surgery, baseline thrombocytopenia \<50,000/µL)
• Pre-existing medical comorbidities or poor performance status (Eastern Cooperative Oncology Group performance status \>2) that would otherwise dictate overnight in-hospital postoperative observation
• Increased distance of residence from index hospital (\>50 miles) or inability to stay within the targeted area (\<50 miles) postoperatively prohibiting timely return to the index hospital in emergent situations
• Lives alone or unable to independently perform Activities of Daily Living and no available caregiver in the immediate postoperative period (POD 0-3)
• Pregnant women will not be included in this study

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

Study Officials

• Paul Graham, M D

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Graham, M D

CONTACT

(832) 829-2547; phgraham@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: November 26, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

US (1)