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

ArmDescriptionAssigned 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.