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NCT06129903Recruiting

Study Assessing the Effects of Early Psychiatric Referral on Mental Health and Quality of Life in People With Sarcoma

The Effect of Enhanced Behavioral Healthcare on Self-Reported Depression, Anxiety, and Health-Related Quality of Life Among Patients With Musculoskeletal Sarcoma Undergoing Surgery: A Randomized Pilot Study

Source: ClinicalTrials.gov · Last updated 15 May 2026

Brief summary (registry, in English)

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 and depression, anxiety, postoperative outcomes, and patient satisfaction in patients undergoing surgery for musculoskeletal sarcoma.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
7 Nov 2023
Start date
7 Nov 2023
Primary completion date
7 Nov 2026
Lead sponsor
Memorial Sloan Kettering Cancer Center
Diseases
Sarcoma
NCT number
NCT06129903

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 7 Nov 2023 to the primary completion date, 7 Nov 2026
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesRecruiting
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Coordinator of this site? Confirm its status
CommackUnited StatesRecruiting
William Beaumont Army Medical Center
Coordinator of this site? Confirm its status
Fort BlissUnited StatesNot yet recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Coordinator of this site? Confirm its status
HarrisonUnited StatesRecruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Coordinator of this site? Confirm its status
MiddletownUnited StatesRecruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Coordinator of this site? Confirm its status
MontvaleUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Coordinator of this site? Confirm its status
UniondaleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.