Status:
RECRUITING
Study Assessing the Effects of Early Psychiatric Referral on Mental Health and Quality of Life in People With Sarcoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Sarcoma
Bone Sarcoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the feasibility of early access to mental healthcare during sarcoma treatment as well as to assess the association between early access to psychiatric care ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Tissue diagnosis of primary bone or soft tissue sarcoma
- o Note: high suspicion of sarcoma on history and imaging acceptable, if reviewed and approved by the PI
- Presenting to the Orthopaedic Surgery Service
- Treatment plan includes surgery at MSK for treatment of the primary sarcoma
- No previous treatment for sarcoma
- Proficient in English
- As determined by use of the Census-LEP question
- The patient's response to the question: "How well do you speak English?" must be "very-well" for inclusion. Additionally, English must be identified as the patient's preferred language for discussing healthcare.
Exclusion
- Significant psychiatric disturbance determined from self-report and/or chart review, sufficient, in the investigator's judgment, to preclude participation in the study" (e.g., underlying severe mental illness, h/o suicide attempts, or h/o psychiatric admissions) Clinical concern at the time of randomization of mental health urgency or emergency requiring evaluation; urgency and emergency will be defined as moderate or high scores, respectively, on the CSSR-S or according to the judgment of the orthopaedic physician evaluating the patient
- Note: investigators considered exclusion of patients with no or mild symptoms of anxiety and depression, however due to risk of new symptoms arising during the course of treatment, risk of underreporting, risk of under detection, and given prior data on the high prevalence of symptoms, we elected to include all patients in this pilot study.
Key Trial Info
Start Date :
November 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 7 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06129903
Start Date
November 7 2023
End Date
November 7 2026
Last Update
May 16 2025
Active Locations (8)
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1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
Commack, New York, United States, 11725