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
Conditions
Brief 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.
Interventions
PROCEDUREChest Radiography
Undergo CXR
PROCEDUREComputed Tomography
Undergo CT-chest
PROCEDUREFollow-Up
Undergo intense follow-up
PROCEDUREImaging Technique
Undergo imaging
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total score for Fear of Cancer Recurrence Inventory - Short Form | Baseline to 12 months after surgery | 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. |
| Mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form | Up to 12 months after surgery | Will be estimated along with a 95% confidence interval within each study group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fear of recurrence | Baseline up to 24 months post-resection | 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. |
| Change in distress | Baseline up to 24 months post-resection | 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. |
| Change in anxiety and depression | Baseline up to 24 months post-resection | 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. |
| Change in out-of-pocket costs | Baseline up to 24 months post-resection | 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 to local recurrence | 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 | Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups. |
| Time to distant metastasis | From time of surgery to distant metastasis as defined by RECIST or death from any cause, whichever occurs first, assessed up to 2 years | Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups. |
| Overall survival | From time of surgery to death, assessed up to 2 years | Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups. |
| Number of missed or extra clinic visits | Up to 2 years | The analysis of number of missed or extra clinic visits will be descriptive in nature. |
Countries
United States
Contacts
CONTACTChristina L Roland, MD
PRINCIPAL_INVESTIGATORChristina L Roland, MD
M.D. Anderson Cancer Center
Outcome results
None listed