Post-Operative Surveillance Intensity for Soft Tissue Sarcoma

Palo Alto (17 mi)

Overseen byChristina L Roland

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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 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.

Inclusion Criteria

I am 18 years old or older.

Exclusion Criteria

I do not speak English.

My cancer has spread to other parts of my body.

Treatment Details

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.

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.