Dysautonomia International

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

Purpose

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.

Conditions

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion 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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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

Recruiting Locations

M D Anderson Cancer Center
Houston, Texas 77030

Contact:
Christina L. Roland
713-792-6940
clroland@mdanderson.org

More Details

Status: Recruiting
Sponsor: M.D. Anderson Cancer Center

Study Contact

Christina L Roland, MD
713-792-6940
clroland@mdanderson.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.