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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chest Radiography, Computed Tomography, Follow-Up, Follow-Up.
- Who it may be relevant to
- Registry 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. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Impact of Limited vs. Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Soft Tissue Sarcoma
Overview
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.
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.
Interventions
- Procedure Chest Radiography
Undergo CXR - Procedure Computed Tomography
Undergo CT-chest - Procedure Follow-Up
Undergo intense follow-up - Procedure Follow-Up
Undergo limited follow-up - Procedure Imaging Technique
Undergo imaging - Other Questionnaire Administration
Ancillary studies
Primary outcome measures
- Total score for Fear of Cancer Recurrence Inventory - Short Form [Time frame: Baseline to 12 months after surgery]
- Mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form [Time frame: Up to 12 months after surgery]
Secondary outcome measures (8)
- Change in fear of recurrence [Time frame: Baseline up to 24 months post-resection]
- Change in distress [Time frame: Baseline up to 24 months post-resection]
- Change in anxiety and depression [Time frame: Baseline up to 24 months post-resection]
- Change in out-of-pocket costs [Time frame: Baseline up to 24 months post-resection]
- 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]
- 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]
- Overall survival [Time frame: From time of surgery to death, assessed up to 2 years]
- Number of missed or extra clinic visits [Time frame: Up to 2 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT04751409 · 2020-0854 · NCI-2021-00436 · 2020-0854