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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 8 sites (Basking Ridge, New Jersey and 7 other locations) |
| Status | Recruiting |
| Started | November 7, 2023 |
| Main results expected | November 7, 2026 |
| Study ends | November 7, 2026 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT06129903 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
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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
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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.
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AYA Sarcoma Survivors: Personalized Exercise Program Pilot
This pilot tests a personalized 12-week exercise program for adolescents and young adults with sarcoma to see if a triage tool can connect them with the right rehabilitation and exercise services.
-
Preoperative Immunonutrition for bone and soft tissue sarcoma patients
This study tests whether a short course of an oral nutrition supplement before surgery can help patients with bone or soft tissue sarcomas recover better after major tumor-related surgery.
-
Using a special dye to guide surgery for sarcoma removal
This study is testing whether a special dye can help surgeons remove sarcomas more accurately by showing them where the cancer ends during surgery.
-
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This study looks at how limb salvage surgery affects the quality of life and daily functioning of people aged 18 to 95 who have had surgery for bone or soft tissue sarcoma in their legs.
-
Using HER2 CAR T cells with checkpoint inhibitors for advanced sarcoma
This study is testing a new treatment that combines personalized CAR T cells with immune boosters to see if it helps people with advanced HER2-positive sarcoma.
-
Combining Retifanlimab with chemotherapy for advanced soft tissue sarcoma
This study is testing if adding Retifanlimab to chemotherapy can help people with advanced soft tissue sarcoma fight their cancer better than the usual treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.