Study Assessing the Effects of Early Psychiatric Referral on Mental Health and Quality of Life in People With Sarcoma
Recruiting · NCT06129903 · Interventional (participants receive a specific treatment) · Lead sponsor: Memorial Sloan Kettering Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
referral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences.
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age ≥18 years
- Tissue diagnosis of primary bone or soft tissue sarcoma
- 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 is running
16 locations listed across 3 US states.
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) - Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) - Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth (All Protocol Activities) - Middletown, New Jersey, United States
- Memorial Sloan Kettering Monmouth (All Protocol Activities) - Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale, New Jersey, United States
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale, New Jersey, United States
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities ) - Commack, New York, United States
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities ) - Commack, New York, United States
- Memorial Sloan Kettering Westchester (All Protocol Activities) - Harrison, New York, United States
- Memorial Sloan Kettering Westchester (All Protocol Activities) - Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center (All protocol activites) - New York, New York, United States
- Memorial Sloan Kettering Cancer Center (All protocol activites) - New York, New York, United States
- Memorial Sloan Kettering Nassau (All protocol activities) - Uniondale, New York, United States
- Memorial Sloan Kettering Nassau (All protocol activities) - Uniondale, New York, United States
- William Beaumont Army Medical Center - Fort Bliss, Texas, United States
- William Beaumont Army Medical Center - Fort Bliss, Texas, United States