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

• 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

Study Timeline

• Study Start: 2023-11-07
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-10
• Study First Posted: 2023-11-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-11-07
• Study Completion: 2026-11-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The number of participants who complete scheduled study visits	2 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.

Trial Locations

Locations (8)

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 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 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 Nassau (All protocol activities); 🇺🇸 Uniondale, New York, United States

William Beaumont Army Medical Center; 🇺🇸 Fort Bliss, Texas, United States