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

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 2

Conditions: Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Treatments: Procedure: Follow-Up; Procedure: Imaging Technique; Procedure: Computed Tomography; Procedure: Chest Radiography; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT04751409

2020-0854 (Other Identifier)

NCI-2021-00436 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 227 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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227 participants in 3 patient groups

Group 1, Arm I (intense follow up)

Experimental group

Description:

Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with CT-chest and imaging of the primary site.

Treatment:

Other: Questionnaire Administration

Procedure: Computed Tomography

Procedure: Imaging Technique

Procedure: Follow-Up

Procedure: Follow-Up

Group 1, Arm II (limited follow-up)

Experimental group

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.

Treatment:

Other: Questionnaire Administration

Procedure: Chest Radiography

Procedure: Computed Tomography

Procedure: Imaging Technique

Procedure: Follow-Up

Procedure: Follow-Up

Group 2 (intense follow up)

Experimental group

Description:

Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.

Treatment:

Other: Questionnaire Administration

Procedure: Computed Tomography

Procedure: Imaging Technique

Procedure: Follow-Up

Procedure: Follow-Up