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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

NCT ID: NCT06129903Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-05-15

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.

Arms & interventions

  • Otherreferral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences.

    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.

Outcome measures

Primary

  • The number of participants who complete scheduled study visits

    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.

    Time frame: 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (8)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

Recruiting
Meredith Bartelstein, MD · Contact

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748

Recruiting
Meredith Bartelstein, MD · Contact

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

Recruiting
Meredith Bartelstein, MD · Contact

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )

Commack, New York, 11725

Recruiting
Meredith Bartelstein, MD · Contact

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

Recruiting
Meredith Bartelstein, MD · Contact

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, 10065

Recruiting
Meredeith Bartelstein, MD · Contact

Memorial Sloan Kettering Nassau (All protocol activities)

Uniondale, New York, 11553

Recruiting
Meredith Bartelstein, MD · Contact

William Beaumont Army Medical Center

Fort Bliss, Texas, 79918

Not Yet Recruiting
Elizabeth M Polfer, MD · Contact