Your session is about to expire
← Back to Search
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 belowSelect...
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
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 moreTrial 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
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,997 Previous Clinical Trials
1,792,639 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak English.I finished my sarcoma treatment 8-14 weeks ago.My cancer has spread to other parts of my body.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1, Arm I (intense follow up)
- Group 2: Group 1, Arm II (limited follow-up)
- Group 3: Group 2 (intense follow up)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger