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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-00436 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0854 | Other Identifier | M D Anderson Cancer Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1, Arm I (intense follow up) | Experimental | Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with CT-chest and imaging of the primary site. |
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| Group 1, Arm II (limited follow-up) | Experimental | 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. |
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| Group 2 (intense follow up) | Experimental | Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest Radiography | Procedure | Undergo CXR |
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| 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 |
| 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 |
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IInclusion Criteria:
Exclusion Criteria:
Pregnant women will be included in this clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina L Roland, MD | Contact | 713-792-6940 | clroland@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Christina L Roland, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M.D. Anderson Cancer Center | View source |
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| Computed Tomography | Procedure | Undergo CT-chest |
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| Follow-Up | Procedure | Undergo intense follow-up |
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| Follow-Up | Procedure | Undergo limited follow-up |
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| Imaging Technique | Procedure | Undergo imaging |
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| Questionnaire Administration | Other | Ancillary studies |
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| 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 |
| ID | Term |
|---|---|
| D014965 | X-Rays |
| D000081204 | Chromatin Immunoprecipitation Sequencing |
| D005500 | Follow-Up Studies |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D047369 | Chromatin Immunoprecipitation |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D059014 | High-Throughput Nucleotide Sequencing |
| D017421 | Sequence Analysis |
| D017422 | Sequence Analysis, DNA |
| D047468 | Immunoprecipitation |
| D007158 | Immunologic Techniques |
| D015331 | Cohort Studies |
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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