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

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.

Study Overview

• Status: Recruiting
• 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
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Computed Tomography; Procedure: Follow-Up; Procedure: Follow-Up; Procedure: Imaging Technique; Procedure: Chest Radiography

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.

• Study Type: Interventional
• Enrollment (Estimated): 227
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Christina L Roland, MD; Phone Number: 713-792-6940; Email: clroland@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Christina L. Roland; Phone Number: 713-792-6940; Email: clroland@mdanderson.org
      • Principal Investigator: Christina L. Roland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

IInclusion Criteria:

• ≥18 years old
• Completion of sarcoma therapy (chemotherapy, radiation therapy and/or surgery) within 8-14 weeks of study enrollment
• Willingness to complete surveys x 2 years

Exclusion Criteria:

• Documented metastatic disease at the time of enrollment
• Non-English-speaking patients

Pregnant women will be included in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1, Arm I (intense follow up); Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with CT-chest and imaging of the primary site.	Other: Questionnaire Administration; Ancillary studies; Procedure: Computed Tomography; Undergo CT-chest; Other Names: CT; CAT; CAT Scan; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Procedure: Follow-Up; Undergo intense follow-up; Other Names: Active Follow-up; Clinical Signs Follow-up; CLSFUP; Follow Up; follow_up; Followed; Followup; Procedure: Follow-Up; Undergo limited follow-up; Other Names: Active Follow-up; Clinical Signs Follow-up; CLSFUP; Follow Up; follow_up; Followed; Followup; Procedure: Imaging Technique; Undergo imaging; Other Names: Diagnostic Imaging Technique; Imaging; imaging procedure; Imaging Procedures; Imaging, Not Otherwise Specified; Medical Imaging
Experimental: Group 1, Arm II (limited follow-up); Patients undergo limited follow-up every 6 months for 2 years consisting of restaging with either CT-chest or CXR and imaging of the primary site.	Other: Questionnaire Administration; Ancillary studies; Procedure: Computed Tomography; Undergo CT-chest; Other Names: CT; CAT; CAT Scan; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Procedure: Follow-Up; Undergo intense follow-up; Other Names: Active Follow-up; Clinical Signs Follow-up; CLSFUP; Follow Up; follow_up; Followed; Followup; Procedure: Follow-Up; Undergo limited follow-up; Other Names: Active Follow-up; Clinical Signs Follow-up; CLSFUP; Follow Up; follow_up; Followed; Followup; Procedure: Imaging Technique; Undergo imaging; Other Names: Diagnostic Imaging Technique; Imaging; imaging procedure; Imaging Procedures; Imaging, Not Otherwise Specified; Medical Imaging; Procedure: Chest Radiography; Undergo CXR; Other Names: Chest X-ray
Experimental: Group 2 (intense follow up); Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.	Other: Questionnaire Administration; Ancillary studies; Procedure: Computed Tomography; Undergo CT-chest; Other Names: CT; CAT; CAT Scan; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Procedure: Follow-Up; Undergo intense follow-up; Other Names: Active Follow-up; Clinical Signs Follow-up; CLSFUP; Follow Up; follow_up; Followed; Followup; Procedure: Follow-Up; Undergo limited follow-up; Other Names: Active Follow-up; Clinical Signs Follow-up; CLSFUP; Follow Up; follow_up; Followed; Followup; Procedure: Imaging Technique; Undergo imaging; Other Names: Diagnostic Imaging Technique; Imaging; imaging procedure; Imaging Procedures; Imaging, Not Otherwise Specified; Medical Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total score for Fear of Cancer Recurrence Inventory - Short Form	Will be calculated as the area under the curve by obtaining patient-reported outcomes at 4 separate time points and then graphically calculating and comparing the area under the curve for each patient. The mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form will be estimated along with a 95% confidence interval within each study group.	Baseline to 12 months after surgery
Mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form	Will be estimated along with a 95% confidence interval within each study group.	Up to 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fear of recurrence	Will be assessed by the Fear of Cancer Recurrence Inventory - Short Form via linear mixed models over time and to compare changes of these assessments over time between the two low-risk groups adjusting for important covariates such age, gender and other patient prognostic factors.	Baseline up to 24 months post-resection
Change in distress	Will be assessed by the Impact of Events scale via linear mixed models over time and to compare changes of these assessments over time between the two low-risk groups adjusting for important covariates such age, gender and other patient prognostic factors.	Baseline up to 24 months post-resection
Change in anxiety and depression	Will be assessed by the Hospital Anxiety and Depression Scale via linear mixed models over time and to compare changes of these assessments over time between the two low-risk groups adjusting for important covariates such age, gender and other patient prognostic factors.	Baseline up to 24 months post-resection
Change in out-of-pocket costs	Will be assessed by the Cost Survey via linear mixed models over time and to compare changes of these assessments over time between the two low-risk groups adjusting for important covariates such age, gender and other patient prognostic factors.	Baseline up to 24 months post-resection
Time to local recurrence	Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups.	From time of surgery to local recurrence as defined by Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause, whichever occurs first, assessed up to 2 years
Time to distant metastasis	Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups.	From time of surgery to distant metastasis as defined by RECIST or death from any cause, whichever occurs first, assessed up to 2 years
Overall survival	Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups.	From time of surgery to death, assessed up to 2 years
Number of missed or extra clinic visits	The analysis of number of missed or extra clinic visits will be descriptive in nature.	Up to 2 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Christina L Roland, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M.D. Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Physical Phenomena; Electromagnetic Phenomena; Magnetic Phenomena; Electromagnetic Radiation; Radiation; Radiation, Ionizing; Immunologic Techniques; Genetic Techniques; Epidemiologic Studies; Epidemiologic Study Characteristics; Chromatin Immunoprecipitation; High-Throughput Nucleotide Sequencing; Sequence Analysis; Sequence Analysis, DNA; Immunoprecipitation; Cohort Studies; X-Rays; Chromatin Immunoprecipitation Sequencing; Follow-Up Studies
• Other Study ID Numbers: 2020-0854 (Other Identifier: M D Anderson Cancer Center); NCI-2021-00436 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No