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Post-Operative Surveillance Intensity for Soft Tissue Sarcoma

Phase 2
Recruiting
Led By Christina L Roland
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years old
Be older than 18 years old
Must not have
Non-English-speaking patients
Documented metastatic disease at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how different follow-up schedules after surgery affects anxiety in patients with soft tissue sarcoma.

Who is the study for?
This trial is for adults over 18 who have had surgery for stage II-III soft tissue sarcoma of the trunk and extremities. They must be willing to complete surveys for two years and should have finished their cancer therapy, including chemotherapy, radiation, or surgery, within 8-14 weeks before joining the study.
What is being tested?
The trial is examining how different follow-up schedules after surgery affect patient anxiety and other outcomes. One group will receive limited surveillance with chest radiography while another will undergo intense surveillance using computed tomography (CT) scans.
What are the potential side effects?
Since this study focuses on post-operative surveillance rather than medication or invasive treatments, side effects are not a primary concern. However, participants may experience anxiety related to the frequency of follow-up visits and imaging tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not speak English.
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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form
Total score for Fear of Cancer Recurrence Inventory - Short Form
Secondary study objectives
Change in anxiety and depression
Change in distress
Change in fear of recurrence
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 2 (intense follow up)Experimental Treatment4 Interventions
Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.
Group II: Group 1, Arm II (limited follow-up)Experimental Treatment5 Interventions
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.
Group III: Group 1, Arm I (intense follow up)Experimental Treatment4 Interventions
Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with CT-chest and imaging of the primary site.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chest Radiography
2018
N/A
~560
Computed Tomography
2017
Completed Phase 2
~2740
Follow-Up
2019
N/A
~50

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,419 Total Patients Enrolled
Christina L RolandPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
32 Total Patients Enrolled
Christina L Roland, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Limited Compared With Intense Post-Operative Surveillance Clinical Trial Eligibility Overview. Trial Name: NCT04751409 — Phase 2
Soft Tissue Sarcoma Research Study Groups: Group 1, Arm I (intense follow up), Group 1, Arm II (limited follow-up), Group 2 (intense follow up)
Soft Tissue Sarcoma Clinical Trial 2023: Limited Compared With Intense Post-Operative Surveillance Highlights & Side Effects. Trial Name: NCT04751409 — Phase 2
Limited Compared With Intense Post-Operative Surveillance 2023 Treatment Timeline for Medical Study. Trial Name: NCT04751409 — Phase 2
~5 spots leftby Dec 2024
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