Study Assessing the Effects of Early Psychiatric Referral on Mental Health and Quality of Life in People With Sarcoma

Study Overview
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Brief Summary
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The purpose of this study is to see if early psychiatric referral can help to recognize and manage symptoms of depression and anxiety in participants with sarcoma, as well as if it can improve health-related quality of life.

Official Title
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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

Conditions
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Sarcoma, Bone Sarcoma, Soft Tissue Sarcoma

Intervention / Treatment
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* Other: referral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Tissue diagnosis of primary bone or soft tissue sarcoma 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early Psychiatric Referral<br>Participants will be randomized to the Early Psychiatric Referral group | Other: referral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences.<br>* 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.<br>|
| No Referral<br>Participants will be randomized to the No Referral group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants who complete scheduled study visits | This study will evaluate the feasibility of conducting a randomized clinical trial studying the impact of early referral to psychiatry on depression and anxiety symptoms in patients with musculoskeletal sarcoma by adherence endpoint. Adherence rate is defined as the number of participants completing all study requirements divided by the number of participants consented. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcoma, Bone Sarcoma, Soft Tissue Sarcoma, Quality of Life, 23-247, Memorial Sloan Kettering Cancer Center