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
NCT ID: NCT04751409
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
227 participants
INTERVENTIONAL
2020-12-28
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Computed Tomography
Undergo CT-chest
Follow-Up
Undergo intense follow-up
Imaging Technique
Undergo imaging
Questionnaire Administration
Ancillary studies
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.
Chest Radiography
Undergo CXR
Computed Tomography
Undergo CT-chest
Follow-Up
Undergo limited follow-up
Imaging Technique
Undergo imaging
Questionnaire Administration
Ancillary studies
Group 2 (intense follow up)
Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.
Computed Tomography
Undergo CT-chest
Follow-Up
Undergo intense follow-up
Imaging Technique
Undergo imaging
Questionnaire Administration
Ancillary studies
Interventions
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Chest Radiography
Undergo CXR
Computed Tomography
Undergo CT-chest
Follow-Up
Undergo intense follow-up
Follow-Up
Undergo limited follow-up
Imaging Technique
Undergo imaging
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Non-English-speaking patients
Pregnant women will be included in this clinical trial.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Christina L Roland, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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M.D. Anderson Cancer Center
Other Identifiers
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NCI-2021-00436
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-0854
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0854
Identifier Type: -
Identifier Source: org_study_id
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