Recruiting
Study Assessing the Effects of Early Psychiatric Referral on Mental Health and Quality of Life in People With Sarcoma
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.
ClinicalTrials.gov IDNCT06129903
PhaseNA
Enrollment60
SponsorMemorial Sloan Kettering Cancer Center
Age18 Years
SexALL
Conditions studied
Sarcoma, Bone Sarcoma, Soft Tissue Sarcoma
About this study
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.
Interventions
- Other: referral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences. — The primary intervention in this study is referral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences. This study will not dictate specific psychiatry interventions beyond providing the referral.
Primary outcomes
- The number of participants who complete scheduled study visits (2 years)
Eligibility information
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.
Study locations
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey 07920 United States
- Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey 07748 United States
- Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey 07645 United States
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities ), Commack, New York 11725 United States
- Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York 10604 United States
- Memorial Sloan Kettering Cancer Center (All protocol activites), New York, New York 10065 United States
- Memorial Sloan Kettering Nassau (All protocol activities), Uniondale, New York 11553 United States
- William Beaumont Army Medical Center, Fort Bliss, Texas 79918 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.