Recruiting
Phase 2

Follow-Up Types

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04751409

Conditions

Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chest Radiography

Computed Tomography

Follow-Up

Follow-Up

Imaging Technique

Study Details

Brief summary:

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.

Conditions

Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Study ID

NCT04751409

Start date

Dec 28, 2020

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

IInclusion Criteria:

  • ≥18 years old
  • Completion of sarcoma therapy (chemotherapy, radiation therapy and/or surgery) within 8-14 weeks of study enrollment
  • Willingness to complete surveys x 2 years

Exclusion Criteria:

  • Documented metastatic disease at the time of enrollment
  • Non-English-speaking patients

Pregnant women will be included in this clinical trial.

Study Design

Enrollment

227 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group 1, Arm I (intense follow up)

Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with CT-chest and imaging of the primary site.

experimental: Group 1, Arm II (limited follow-up)

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.

experimental: Group 2 (intense follow up)

Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.

Interventions

Chest Radiography

Undergo CXR

Computed Tomography

Undergo CT-chest

Follow-Up

Undergo intense follow-up

Follow-Up

Undergo limited follow-up

Imaging Technique

Undergo imaging

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Total score for Fear of Cancer Recurrence Inventory - Short Form [ Time Frame: Baseline to 12 months after surgery ]
  • Mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form [ Time Frame: Up to 12 months after surgery ]

Central Contacts and Locations

Central contacts

Christina L Roland, MD

713-792-6940clroland@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Christina L. Roland

713-792-6940clroland@mdanderson.org

Principal Investigator:

Christina L. Roland

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-03-05.