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Study Assessing the Effects of Early Psychiatric Referral on Mental Health and Quality of Life in People With Sarcoma
Trial Status: active
This clinical trial tests the feasibility and how well early psychiatric referral works to improve depression and anxiety symptoms among patients receiving surgery for bone or soft tissue sarcoma. People who are diagnosed with and undergoing treatment for cancer commonly experience depression and anxiety. The usual approach to treating depression and anxiety is to refer the patient to a psychiatrist only after they experience a worsening of mental health, or to leave it up to the patient to request a psychiatric referral from their doctor. A psychiatric referral is when your doctor recommends you to see a psychiatrist who can help to diagnose and treat any mental health concerns such as depression and anxiety. Receiving early psychiatric referral may help to recognize and manage symptoms of depression and anxiety in people with sarcoma, as well as improve health-related quality of life.
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 principal investigator (PI)
Presenting to the Orthopaedic Surgery Service
Treatment plan includes surgery at Memorial Sloan Kettering (MSK) for treatment of the primary sarcoma
No previous treatment for sarcoma
Proficient in English
* As determined by use of the Census-limited English proficiency (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, history of [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 Colombia Suicide Severity Rating Scale (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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06129903.
I. To evaluate the feasibility of conducting a randomized clinical trial studying the impact of early referral to psychiatry (versus no referral) on depression and anxiety symptoms in patients with musculoskeletal sarcoma by examining the rates of eligibility, acceptance, uptake rate, and adherence.
SECONDARY OBJECTIVES:
I. Evaluate whether early psychiatric referral at the time of initial tissue diagnosis of musculoskeletal sarcoma is associated with an improvement in symptoms of depression, compared with no referral at 3 months post surgery.
II. Evaluate whether early psychiatric referral is associated with an improvement in symptoms of anxiety, compared with no referral at 3 months post surgery.
III. Evaluate whether early psychiatric referral is associated with an improvement in patient-reported outcomes (as determined by Patient Reported Outcome Measurement Information System [PROMIS-29] scores), compared with no referral at 1 year post surgery.
IV. Evaluate associations between disease factors (disease state, goals of care) and symptoms of anxiety and depression.
V. Determine patients’ perspectives on their sarcoma care from the Orthopaedic Surgery Service (for all patients in the study) at 1 year after surgery.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive early psychiatric referral to a consult liaison psychiatrist within 2 weeks of randomization and 6 weeks after surgery. Patients may receive further visits as needed.
GROUP II: Patients receive standard care.
After completion of study intervention, patients are followed up at 3 months, 6 months, and 1 year after surgery.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center