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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

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ClinicalTrials.gov Identifier: NCT04751409
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Procedure: Chest Radiography Procedure: Computed Tomography Procedure: Follow-Up Procedure: Imaging Technique Other: Questionnaire Administration Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating the Impact of Limited vs. Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Soft Tissue Sarcoma
Actual Study Start Date : December 28, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Procedure: Computed Tomography
Undergo CT-chest
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Procedure: Follow-Up
Undergo intense follow-up
Other Names:
  • Active Follow-up
  • Clinical Signs Follow-up
  • CLSFUP
  • Follow Up
  • follow_up
  • Followed
  • Followup

Procedure: Imaging Technique
Undergo imaging
Other Names:
  • Diagnostic Imaging Technique
  • Imaging
  • imaging procedure
  • Imaging Procedures
  • Imaging, Not Otherwise Specified
  • Medical Imaging

Other: Questionnaire Administration
Ancillary studies
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.
 Procedure: Chest Radiography
Undergo CXR
Other Name: Chest X-ray

Procedure: Computed Tomography
Undergo CT-chest
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Procedure: Follow-Up
Undergo limited follow-up
Other Names:
  • Active Follow-up
  • Clinical Signs Follow-up
  • CLSFUP
  • Follow Up
  • follow_up
  • Followed
  • Followup

Procedure: Imaging Technique
Undergo imaging
Other Names:
  • Diagnostic Imaging Technique
  • Imaging
  • imaging procedure
  • Imaging Procedures
  • Imaging, Not Otherwise Specified
  • Medical Imaging

Other: Questionnaire Administration
Ancillary studies
Experimental: Group 2 (intense follow up)
Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.
 Procedure: Computed Tomography
Undergo CT-chest
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Procedure: Follow-Up
Undergo intense follow-up
Other Names:
  • Active Follow-up
  • Clinical Signs Follow-up
  • CLSFUP
  • Follow Up
  • follow_up
  • Followed
  • Followup

Procedure: Imaging Technique
Undergo imaging
Other Names:
  • Diagnostic Imaging Technique
  • Imaging
  • imaging procedure
  • Imaging Procedures
  • Imaging, Not Otherwise Specified
  • Medical Imaging

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >= 18 years old
  • Completion of sarcoma therapy (chemotherapy, radiation therapy and/or surgery) within 8 weeks of study enrollment
  • Willingness to complete surveys x 2 years
  • Pregnant women will be included in this clinical trial

Exclusion Criteria:

  • Documented metastatic disease at the time of enrollment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04751409


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Christina L. Roland    713-792-6940    clroland@mdanderson.org   
Principal Investigator: Christina L. Roland         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Christina L Roland M.D. Anderson Cancer Center
More Information
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04751409    
Other Study ID Numbers: 2020-0854
NCI-2021-00436 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0854 ( Other Identifier: M D Anderson Cancer Center )
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms