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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Change in anxiety and depression

Change in distress

Change in fear of recurrence

+5 more

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

~2720

Follow-Up

2019

N/A

~50

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,090 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aim of this experimental endeavor?

"This medical trial's primary outcome is to measure the mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form over a time frame ranging from baseline to 12 months post-surgery. Additionally, secondary outcomes are being monitored such as time to local recurrence (Kaplan-Meier method), degree of change in anxiety and depression (Hospital Anxiety and Depression Scale) along with out-of-pocket expenditures incurred by patients (Cost Survey). All these factors will be compared between two low risk groups whilst taking into account age, gender, and other relevant patient prognostic variables."

Answered by AI

How precarious is Follow-Up for individuals?

"Taking into account the fact that this is Phase 2 clinical trial with only some evidence of safety, but no proof of efficacy, our team at Power gave Follow-Up a score of 2 on their scale from 1 to 3."

Answered by AI

How many volunteers are engaged in this clinical experiment?

"Affirmative. Clinicaltrials.gov data indicates that this medical experiment, originally posted on December 28th 2020, is actively looking for enrollees. Specifically, 227 patients need to be collected from 1 specific site."

Answered by AI

Is enrollment still available for this research endeavor?

"Per information on clinicaltrials.gov, this trial is actively enrolling patients. It was initially posted to the database on December 28th 2020 and last amended on September 28th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04751409.

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