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
Primary Purpose
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
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chest Radiography
Computed Tomography
Follow-Up
Follow-Up
Imaging Technique
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Eligibility Criteria
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.
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1, Arm I (intense follow up)
Group 1, Arm II (limited follow-up)
Group 2 (intense follow up)
Arm Description
Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with CT-chest and imaging of the primary site.
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.
Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Overall survival
Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups.
Number of missed or extra clinic visits
The analysis of number of missed or extra clinic visits will be descriptive in nature.
Full Information
NCT ID
NCT04751409
First Posted
February 8, 2021
Last Updated
September 12, 2023
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT04751409
Brief Title
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
Official Title
Evaluating the Impact of Limited vs. Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Soft Tissue Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
227 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1, Arm I (intense follow up)
Arm Type
Experimental
Arm Description
Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with CT-chest and imaging of the primary site.
Arm Title
Group 1, Arm II (limited follow-up)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2 (intense follow up)
Arm Type
Experimental
Arm Description
Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.
Intervention Type
Procedure
Intervention Name(s)
Chest Radiography
Other Intervention Name(s)
Chest X-ray
Intervention Description
Undergo CXR
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo CT-chest
Intervention Type
Procedure
Intervention Name(s)
Follow-Up
Other Intervention Name(s)
Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up, follow_up, Followed, Followup
Intervention Description
Undergo intense follow-up
Intervention Type
Procedure
Intervention Name(s)
Follow-Up
Other Intervention Name(s)
Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up, follow_up, Followed, Followup
Intervention Description
Undergo limited follow-up
Intervention Type
Procedure
Intervention Name(s)
Imaging Technique
Other Intervention Name(s)
Diagnostic Imaging Technique, Imaging, imaging procedure, Imaging Procedures, Imaging, Not Otherwise Specified, Medical Imaging
Intervention Description
Undergo imaging
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Total score for Fear of Cancer Recurrence Inventory - Short Form
Description
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.
Time Frame
Baseline to 12 months after surgery
Title
Mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form
Description
Will be estimated along with a 95% confidence interval within each study group.
Time Frame
Up to 12 months after surgery
Secondary Outcome Measure Information:
Title
Change in fear of recurrence
Description
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.
Time Frame
Baseline up to 24 months post-resection
Title
Change in distress
Description
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.
Time Frame
Baseline up to 24 months post-resection
Title
Change in anxiety and depression
Description
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.
Time Frame
Baseline up to 24 months post-resection
Title
Change in out-of-pocket costs
Description
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.
Time Frame
Baseline up to 24 months post-resection
Title
Time to local recurrence
Description
Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups.
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
Title
Time to distant metastasis
Description
Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups.
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
Title
Overall survival
Description
Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups.
Time Frame
From time of surgery to death, assessed up to 2 years
Title
Number of missed or extra clinic visits
Description
The analysis of number of missed or extra clinic visits will be descriptive in nature.
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina L Roland, MD
Phone
713-792-6940
Email
clroland@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina L Roland, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina L. Roland
Phone
713-792-6940
Email
clroland@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Christina L. Roland
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
M.D. Anderson Cancer Center
Learn more about this trial
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
We'll reach out to this number within 24 hrs