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

Not Applicable
Recruiting
Conditions
Sarcoma
Bone Sarcoma
Soft Tissue Sarcoma
Interventions
Other: referral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences.
Registration Number
NCT06129903
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
60
Inclusion Criteria
  • Age โ‰ฅ18 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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Early Psychiatric Referralreferral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences.Participants will be randomized to the Early Psychiatric Referral group
Primary Outcome Measures
NameTimeMethod
The number of participants who complete scheduled study visits2 years

The study will 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 Outcome Measures
NameTimeMethod

Trial Locations

Locations (8)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

๐Ÿ‡บ๐Ÿ‡ธ

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

๐Ÿ‡บ๐Ÿ‡ธ

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

๐Ÿ‡บ๐Ÿ‡ธ

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )

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Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

๐Ÿ‡บ๐Ÿ‡ธ

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All protocol activites)

๐Ÿ‡บ๐Ÿ‡ธ

New York, New York, United States

Memorial Sloan Kettering Nassau (All protocol activities)

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Uniondale, New York, United States

William Beaumont Army Medical Center

๐Ÿ‡บ๐Ÿ‡ธ

Fort Bliss, Texas, United States

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