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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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
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* Procedure: Chest Radiography
* Procedure: Computed Tomography
* Procedure: Follow-Up
* Procedure: Follow-Up
* Procedure: Imaging Technique
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1, Arm I (intense follow up)<br>Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with CT-chest and imaging of the primary site. | Procedure: Computed Tomography<br>* Undergo CT-chest<br>* Other names: tomography;Procedure: Follow-Up<br>* Undergo intense follow-up<br>* Other names: Followup;Procedure: Imaging Technique<br>* Undergo imaging<br>* Other names: Medical Imaging;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Group 1, Arm II (limited follow-up)<br>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. | Procedure: Chest Radiography<br>* Undergo CXR<br>* Other names: Chest X-ray;Procedure: Computed Tomography<br>* Undergo CT-chest<br>* Other names: tomography;Procedure: Follow-Up<br>* Undergo limited follow-up<br>* Other names: Followup;Procedure: Imaging Technique<br>* Undergo imaging<br>* Other names: Medical Imaging;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Group 2 (intense follow up)<br>Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I. | Procedure: Computed Tomography<br>* Undergo CT-chest<br>* Other names: tomography;Procedure: Follow-Up<br>* Undergo intense follow-up<br>* Other names: Followup;Procedure: Imaging Technique<br>* Undergo imaging<br>* Other names: Medical Imaging;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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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 |