NCT04751409

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P75+ for phase_2

Timeline
18mo left

Started Dec 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Dec 2020Dec 2027

Study Start

First participant enrolled

December 28, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

7 years

First QC Date

February 8, 2021

Last Update Submit

March 3, 2026

Conditions

Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Outcome Measures

Primary Outcomes (2)

  • Total score for Fear of Cancer Recurrence Inventory - Short Form

    Will be calculated as the area under the curve by obtaining patient-reported outcomes at 4 separate time points and then graphically calculating and comparing the area under the curve for each patient. The mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form will be estimated along with a 95% confidence interval within each study group.

    Baseline to 12 months after surgery

  • Mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form

    Will be estimated along with a 95% confidence interval within each study group.

    Up to 12 months after surgery

Secondary Outcomes (8)

  • Change in fear of recurrence

    Baseline up to 24 months post-resection

  • Change in distress

    Baseline up to 24 months post-resection

  • Change in anxiety and depression

    Baseline up to 24 months post-resection

  • Change in out-of-pocket costs

    Baseline up to 24 months post-resection

  • Time to local recurrence

    From time of surgery to local recurrence as defined by Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause, whichever occurs first, assessed up to 2 years

  • +3 more secondary outcomes

Study Arms (3)

Group 1, Arm I (intense follow up)

EXPERIMENTAL

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

Procedure: Computed TomographyProcedure: Follow-UpProcedure: Imaging TechniqueOther: Questionnaire Administration

Group 1, Arm II (limited follow-up)

EXPERIMENTAL

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.

Procedure: Chest RadiographyProcedure: Computed TomographyProcedure: Follow-UpProcedure: Imaging TechniqueOther: Questionnaire Administration

Group 2 (intense follow up)

EXPERIMENTAL

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

Procedure: Computed TomographyProcedure: Follow-UpProcedure: Imaging TechniqueOther: Questionnaire Administration

Interventions

Chest RadiographyPROCEDURE

Undergo CXR

Also known as: Chest X-ray
Group 1, Arm II (limited follow-up)
Computed TomographyPROCEDURE

Undergo CT-chest

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Group 1, Arm I (intense follow up)Group 1, Arm II (limited follow-up)Group 2 (intense follow up)
Follow-UpPROCEDURE

Undergo intense follow-up

Also known as: Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up, follow_up, Followed, Followup
Group 1, Arm I (intense follow up)Group 2 (intense follow up)
Imaging TechniquePROCEDURE

Undergo imaging

Also known as: Diagnostic Imaging Technique, Imaging, imaging procedure, Imaging Procedures, Imaging, Not Otherwise Specified, Medical Imaging
Group 1, Arm I (intense follow up)Group 1, Arm II (limited follow-up)Group 2 (intense follow up)
Questionnaire AdministrationOTHER

Ancillary studies

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • Documented metastatic disease at the time of enrollment
  • Non-English-speaking patients
  • Pregnant women will be included in this clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Interventions

X-RaysChromatin Immunoprecipitation SequencingFollow-Up Studies

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, IonizingChromatin ImmunoprecipitationGenetic TechniquesInvestigative TechniquesHigh-Throughput Nucleotide SequencingSequence AnalysisSequence Analysis, DNAImmunoprecipitationImmunologic TechniquesCohort StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Christina L Roland, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina L Roland, MD

CONTACT

713-792-6940clroland@mdanderson.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 12, 2021

Study Start

December 28, 2020

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

US(1)