NCT04751409

Evaluating the Impact of Limited Compared With Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Stage II-III Soft Tissue Sarcoma of the Trunk and Extremities

Evaluating the Impact of Limited vs. Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Soft Tissue Sarcoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 227 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how anxiety is affected by 2 types of follow-up after surgery, limited follow-up and intense follow-up, in patients with stage II-III soft tissue sarcoma of the trunk and extremities. In cancer survivors, the fear of cancer coming back (recurring) is common and may persist long after the end of treatment. It may also be exacerbated by return visits for imaging (surveillance). The purpose of this study is to determine how patients' anxiety and other cancer-related outcomes are affected by how often surveillance is done.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate whether a risk-based limited follow-up surveillance is associated with reduced patient anxiety compared to risk-based intense surveillance. SECONDARY OBJECTIVE: I. To evaluate the impact of reduced surveillance in low-risk patients on overall survival, time to local or distant recurrence, anxiety at early and late time-points, out of pocket costs, and number of missed or extra clinic visits, compared to the risk-based intense follow-up in both low-risk and high-risk patients. OUTLINE: Patients are assigned to 1 of 2 groups based on risk status. GROUP 1 (LOW RISK): Patients are randomized to 1 of 2 arms. ARM I: Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with computed tomography (CT)-chest and imaging of the primary site. ARM II: Patients undergo limited follow-up every 6 months for 2 years consisting of restaging with either CT-chest or chest x-ray (CXR) and imaging of the primary site. GROUP 2 (HIGH RISK): Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.

Conditions

• Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Chest Radiography	Undergo CXR
PROCEDURE	Computed Tomography	Undergo CT-chest
PROCEDURE	Follow-Up	Undergo intense follow-up
PROCEDURE	Follow-Up	Undergo limited follow-up
PROCEDURE	Imaging Technique	Undergo imaging
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-12-28
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2021-02-12
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States