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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04751409
Collaborator
(none)
227
1
3
48.1
4.7

Study Details

Study Description

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
  • Procedure: Chest Radiography
  • Procedure: Computed Tomography
  • Procedure: Follow-Up
  • Procedure: Follow-Up
  • Procedure: Imaging Technique
  • Other: Questionnaire Administration
Phase 2

Detailed Description

PRIMARY OBJECTIVE:
  1. To evaluate whether a risk-based limited follow-up surveillance is associated with reduced patient anxiety compared to risk-based intense surveillance.
SECONDARY OBJECTIVE:
  1. 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

Study Type:
Interventional
Anticipated 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 :
Dec 28, 2020
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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 Names:
  • 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

    Primary Outcome Measures

    1. 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.

    2. 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 Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Christina L Roland, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04751409
    Other Study ID Numbers:
    • 2020-0854
    • NCI-2021-00436
    • 2020-0854
    First Posted:
    Feb 12, 2021
    Last Update Posted:
    Jun 10, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 10, 2022