Clinical trial NCT04751409: 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
Official title: Evaluating the Impact of Limited vs. Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate whether a risk-based limited follow-up surveillance is associated with reduced patient anxiety compared to risk-based intense surveillance.

SECONDARY OBJECTIVE:

I. To evaluate the impact of reduced surveillance in low-risk patients on overall survival, time to local or distant recurrence, anxiety at early and late time-points, out of pocket costs, and number of missed or extra clinic visits, compared to the risk-based intense follow-up in both low-risk and high-risk patients.

OUTLINE: Patients are assigned to 1 of 2 groups based on risk status.

GROUP 1 (LOW RISK): Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with computed tomography (CT)-chest and imaging of the primary site.

ARM II: Patients undergo limited follow-up every 6 months for 2 years consisting of restaging with either CT-chest or chest x-ray (CXR) and imaging of the primary site.

GROUP 2 (HIGH RISK): Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.

Eligibility criteria: 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.

Primary outcomes:
measure: Total score for Fear of Cancer Recurrence Inventory - Short Form
timeFrame: Baseline to 12 months after surgery
measure: Mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form
timeFrame: Up to 12 months after surgery
Secondary outcomes:
measure: Change in fear of recurrence
timeFrame: Baseline up to 24 months post-resection
measure: Change in distress
timeFrame: Baseline up to 24 months post-resection
measure: Change in anxiety and depression
timeFrame: Baseline up to 24 months post-resection
measure: Change in out-of-pocket costs
timeFrame: Baseline up to 24 months post-resection
measure: Time to local recurrence
timeFrame: 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
measure: Time to distant metastasis
timeFrame: From time of surgery to distant metastasis as defined by RECIST or death from any cause, whichever occurs first, assessed up to 2 years
measure: Overall survival
timeFrame: From time of surgery to death, assessed up to 2 years
measure: Number of missed or extra clinic visits
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Christina L Roland, MD
role: PRINCIPAL_INVESTIGATOR
References: