Clinical trial Recruiting at 7 sites Interventional Ages 18 and up

Assessing early psychiatric referral effects on mental health in sarcoma patients

Official title: 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

Run by Memorial Sloan Kettering Cancer Center · NCT06129903 · Data updated 2026-11-12

This study tests whether getting early mental health support helps sarcoma patients feel less anxious and depressed while recovering from surgery.

More Sarcoma trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorMemorial Sloan Kettering Cancer Center
Academic / other
Locations8 sites (Basking Ridge, New Jersey and 7 other locations)
StatusRecruiting
StartedNovember 7, 2023
Main results expectedNovember 7, 2026
Study endsNovember 7, 2026
Registry record updatedMay 15, 2026
Trial IDNCT06129903 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with a confirmed diagnosis of primary bone or soft tissue sarcoma who are proficient in English.

Probably not a fit

Patients with significant psychiatric disturbances or severe mental illness may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the feasibility of providing early access to mental healthcare for patients undergoing treatment for sarcoma. It aims to evaluate the relationship between early psychiatric referrals and outcomes such as depression, anxiety, postoperative recovery, and overall patient satisfaction. Participants will be referred to the Psychiatry and Behavioral Sciences department at Memorial Sloan Kettering Cancer Center for support during their surgical treatment. The study focuses on patients with primary bone or soft tissue sarcoma who are scheduled for surgery.

Why it matters

Potential benefit: If successful, this study could improve mental health outcomes and quality of life for sarcoma patients undergoing treatment.

How similar studies have gone: Other studies have shown promising results in improving mental health outcomes through early psychiatric intervention in cancer care.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
    Basking Ridge, New Jersey, United States
    Recruiting
  • Memorial Sloan Kettering Monmouth (All Protocol Activities)
    Middletown, New Jersey, United States
    Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
    Montvale, New Jersey, United States
    Recruiting
  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
    Commack, New York, United States
    Recruiting
  • Memorial Sloan Kettering Westchester (All Protocol Activities)
    Harrison, New York, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center (All protocol activites)
    New York, New York, United States
    Recruiting
Show 2 more locations
  • Memorial Sloan Kettering Nassau (All protocol activities)
    Uniondale, New York, United States
    Recruiting
  • William Beaumont Army Medical Center
    Fort Bliss, Texas, United States
    Not yet recruiting

Study contacts

  • Principal investigator: Meredith Bartelstein, MD — Memorial Sloan Kettering Cancer Center
  • Study coordinator: Meredith Bartelstein, MD
  • Email: bartelsm@mskcc.org
  • Phone: 212-639-8684

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.