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

Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 Clinical Trial

Official title:

Evaluating the Impact of Limited vs. Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Soft Tissue Sarcoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04751409
• Other study ID #: 2020-0854
• Secondary ID: NCI-2021-0043620
• Status: Recruiting
• Phase: Phase 2
• Start date: December 28, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: Christina L Roland, MD
• Phone: 713-792-6940
• Email: clroland[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 227
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma
• 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

Intervention

Procedure:
• 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

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 12 months after surgery
Primary	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.	Up to 12 months after surgery
Secondary	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.	Baseline up to 24 months post-resection
Secondary	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.	Baseline up to 24 months post-resection
Secondary	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.	Baseline up to 24 months post-resection
Secondary	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.	Baseline up to 24 months post-resection
Secondary	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.	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
Secondary	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.	From time of surgery to distant metastasis as defined by RECIST or death from any cause, whichever occurs first, assessed up to 2 years
Secondary	Overall survival	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
Secondary	Number of missed or extra clinic visits	The analysis of number of missed or extra clinic visits will be descriptive in nature.	Up to 2 years

External Links

•   M.D. Anderson Cancer Center