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
March 3, 2026 updated by: M.D. Anderson Cancer Center
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christina L Roland, MD
- Phone Number: 713-792-6940
- Email: clroland@mdanderson.org
Study Locations
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
Ancillary studies
Undergo CT-chest
Other Names:
Undergo intense follow-up
Other Names:
Undergo limited follow-up
Other Names:
Undergo imaging
Other Names:
|
|
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.
|
Ancillary studies
Undergo CT-chest
Other Names:
Undergo intense follow-up
Other Names:
Undergo limited follow-up
Other Names:
Undergo imaging
Other Names:
Undergo CXR
Other Names:
|
|
Experimental: Group 2 (intense follow up)
Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.
|
Ancillary studies
Undergo CT-chest
Other Names:
Undergo intense follow-up
Other Names:
Undergo limited follow-up
Other Names:
Undergo imaging
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total score for Fear of Cancer Recurrence Inventory - Short Form
Time Frame: 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.
|
Baseline to 12 months after surgery
|
|
Mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form
Time Frame: Up to 12 months after surgery
|
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
Time Frame: 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.
|
Baseline up to 24 months post-resection
|
|
Change in distress
Time Frame: 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.
|
Baseline up to 24 months post-resection
|
|
Change in anxiety and depression
Time Frame: 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.
|
Baseline up to 24 months post-resection
|
|
Change in out-of-pocket costs
Time Frame: 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.
|
Baseline up to 24 months post-resection
|
|
Time to local recurrence
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
|
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
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
|
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
Time Frame: 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.
|
From time of surgery to death, assessed up to 2 years
|
|
Number of missed or extra clinic visits
Time Frame: Up to 2 years
|
The analysis of number of missed or extra clinic visits will be descriptive in nature.
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christina L Roland, MD, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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