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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
227
Undergo CXR
Undergo CT-chest
Undergo intense follow-up
Undergo limited follow-up
Undergo imaging
Ancillary studies
M D Anderson Cancer Center
Houston, Texas, United States
RECRUITINGTotal 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.
Time frame: 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.
Time frame: Up to 12 months after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 2 years
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