Follow-Up for Soft Tissue Sarcoma

M D Anderson Cancer Center, Houston, TX
Soft Tissue Sarcoma+3 More ConditionsFollow-Up - Procedure
Eligibility
18+
All Sexes

Study Summary

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

Eligible Conditions
  • Stage IIIA Soft Tissue Sarcoma
  • Stage II Soft Tissue Sarcoma
  • Stage IIIB Soft Tissue Sarcoma
  • Stage III Soft Tissue Sarcoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Up to 2 years

Month 12
Total score for Fear of Cancer Recurrence Inventory - Short Form
Month 24
Change in anxiety and depression
Change in distress
Change in fear of recurrence
Change in out-of-pocket costs
Year 2
Overall survival
Year 2
Time to distant metastasis
Year 2
Time to local recurrence
Month 12
Mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form
Up to 2 years
Number of missed or extra clinic visits

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Group 2 (intense follow up)
1 of 3
Group 1, Arm I (intense follow up)
1 of 3
Group 1, Arm II (limited follow-up)
1 of 3

Experimental Treatment

227 Total Participants · 3 Treatment Groups

Primary Treatment: Follow-Up · No Placebo Group · Phase 2

Group 2 (intense follow up)Experimental Group · 4 Interventions: Computed Tomography, Imaging Technique, Questionnaire Administration, Follow-Up · Intervention Types: Procedure, Procedure, Other, Procedure
Group 1, Arm I (intense follow up)Experimental Group · 4 Interventions: Computed Tomography, Imaging Technique, Questionnaire Administration, Follow-Up · Intervention Types: Procedure, Procedure, Other, Procedure
Group 1, Arm II (limited follow-up)Experimental Group · 5 Interventions: Computed Tomography, Chest Radiography, Imaging Technique, Questionnaire Administration, Follow-Up · Intervention Types: Procedure, Procedure, Procedure, Other, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2710
Chest Radiography
2018
N/A
~560

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,849 Previous Clinical Trials
1,793,417 Total Patients Enrolled
Christina L RolandPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
5,032 Total Patients Enrolled
Christina L Roland, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be at least 18 years old.
You have completed treatment for sarcoma (chemotherapy, radiation therapy, or surgery) within the last 8 to 14 weeks before enrolling in the study.
You agree to complete two years of surveys.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.