Assessing early psychiatric referral effects on mental health in sarcoma patients
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
This study tests whether getting early mental health support helps sarcoma patients feel less anxious and depressed while recovering from surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 8 sites (Basking Ridge, New Jersey and 7 other locations) |
| Trial ID | NCT06129903 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with significant psychiatric disturbances or severe mental illness may not benefit from this study.
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 performed: Other studies have shown promising results in improving mental health outcomes through early psychiatric intervention in cancer care.
Eligibility criteria
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 this trial is running
Basking Ridge, New Jersey and 7 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.