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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

ConditionsStage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

Documented metastatic disease at the time of enrollment

Non-English-speaking patients

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chest Radiography

    Procedure/Surgery

    Undergo CXR

  • Computed Tomography

    Procedure/Surgery

    Undergo CT-chest

  • Follow-Up

    Procedure/Surgery

    Undergo intense follow-up

  • Follow-Up

    Procedure/Surgery

    Undergo limited follow-up

  • Imaging Technique

    Procedure/Surgery

    Undergo imaging

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

227 Participants
are divided into 3 treatment groups
Group A: Group 1, Arm I (intense follow up)Experimental treatment 4 interventions
Group B: Group 1, Arm II (limited follow-up)Experimental treatment 5 interventions
Group C: Group 2 (intense follow up)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Total score for Fear of Cancer Recurrence Inventory - Short Form

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.

Time frame
Baseline to 12 months after surgery
2

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.

Time frame
Up to 12 months after surgery

Secondary outcomes

1

Change in fear of recurrence

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.

Time frame
Baseline up to 24 months post-resection
2

Change in distress

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.

Time frame
Baseline up to 24 months post-resection
3

Change in anxiety and depression

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.

Time frame
Baseline up to 24 months post-resection
4

Change in out-of-pocket costs

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.

Time frame
Baseline up to 24 months post-resection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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