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NCT Number: NCT04751409

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

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.

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Key information

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Christina L. Roland

CONTACT

[email protected]

713-792-6940

Christina L. Roland

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chest Radiography

Procedure

Undergo CXR

Other names: Chest X-ray

Computed Tomography

Procedure

Undergo CT-chest

Other names: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Follow-Up

Procedure

Undergo intense follow-up

Other names: Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up, follow_up, Followed, Followup

Imaging Technique

Procedure

Undergo imaging

Other names: Diagnostic Imaging Technique, Imaging, imaging procedure, Imaging Procedures, Imaging, Not Otherwise Specified, Medical Imaging

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Total score for Fear of Cancer Recurrence Inventory - Short Form

    Time frame: Baseline to 12 months after surgery

    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.

  2. Mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form

    Time frame: Up to 12 months after surgery

    Will be estimated along with a 95% confidence interval within each study group.

Secondary outcomes

  1. Change in fear of recurrence

    Time frame: Baseline up to 24 months post-resection

    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.

  2. Change in distress

    Time frame: Baseline up to 24 months post-resection

    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.

  3. Change in anxiety and depression

    Time frame: Baseline up to 24 months post-resection

    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.

  4. Change in out-of-pocket costs

    Time frame: Baseline up to 24 months post-resection

    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.

  5. Time to local recurrence

    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

    Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups.

  6. Time to distant metastasis

    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

    Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups.

  7. Overall survival

    Time frame: From time of surgery to death, assessed up to 2 years

    Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups.

  8. Number of missed or extra clinic visits

    Time frame: Up to 2 years

    The analysis of number of missed or extra clinic visits will be descriptive in nature.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina L Roland, MD

CONTACT

[email protected]

713-792-6940

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2021
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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