Recruiting

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

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06129903

Conditions

Sarcoma

Bone Sarcoma

Soft Tissue Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Sarcoma

Bone Sarcoma

Soft Tissue Sarcoma

Study ID

NCT06129903

Start date

Nov 7, 2023

Status verified date

May, 2026

Completion date

Nov 7, 2026

Anticipated

Primary completion date

Nov 7, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Early Psychiatric Referral

Participants will be randomized to the Early Psychiatric Referral group

no intervention: No Referral

Participants will be randomized to the No Referral group

Interventions

referral 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.

Primary outcome measure

The number of participants who complete scheduled study visits [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Meredith Bartelstein, MD

212-639-8684 bartelsm@mskcc.org

Yesne Alici, MD

646-888-0025 aliciy@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Meredith Bartelstein, MD

212-639-8684

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Meredith Bartelstein, MD

212-639-8684

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Meredith Bartelstein, MD

212-639-8684

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )

Recruiting

Commack, New York, United States, 11725

Contacts

Meredith Bartelstein, MD

212-639-8684

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Meredith Bartelstein, MD

212-639-8684

Memorial Sloan Kettering Cancer Center (All protocol activites)

Recruiting

New York, New York, United States, 10065

Contacts

Meredeith Bartelstein, MD

212-639-8684

Memorial Sloan Kettering Nassau (All protocol activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Meredith Bartelstein, MD

212-639-8684

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

Sarcoma
Bone Sarcoma
Soft Tissue Sarcoma
Quality of Life
23-247
Memorial Sloan Kettering Cancer Center

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-15.