Evaluating the Impact of Limited Compared With Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Stage II-III Soft Tissue Sarcoma of the Trunk and Extremities

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04751409
Phase
PHASE2
Status
Recruiting
Apply to this trial

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 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chest Radiography — PROCEDURE
    Undergo CXR
  • Computed Tomography — PROCEDURE
    Undergo CT-chest
  • Follow-Up — PROCEDURE
    Undergo intense follow-up
  • Follow-Up — PROCEDURE
    Undergo limited follow-up
  • Imaging Technique — PROCEDURE
    Undergo imaging
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Dec 28, 2020
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
227 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Total score for Fear of Cancer Recurrence Inventory - Short Form [ Time Frame: Baseline to 12 months after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Christina L. Roland
[email protected]
713-792-6940
Christina L. Roland (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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