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RecruitingNCT06129903Updated May 15, 2026

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

An interventional study of referral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences. in Sarcoma, Bone Sarcoma and Soft Tissue Sarcoma, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Nov 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Sarcoma
  • Bone Sarcoma
  • Soft Tissue Sarcoma

Keywords

  • Sarcoma
  • Bone Sarcoma
  • Soft Tissue Sarcoma
  • Quality of Life
  • 23-247
  • Memorial Sloan Kettering Cancer Center
03

In context

Sarcoma

1,607 studies on the registry are indexed under Sarcoma; 366 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 1,255 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Early Psychiatric Referral

    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.

  • No intervention
    No Referral

    Participants will be randomized to the No Referral group

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.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

7 of 8 sites recruiting
  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
    Basking Ridge, New Jersey 07920, United States
    Recruiting
    • Meredith Bartelstein, MD · Contact212-639-8684
  • Memorial Sloan Kettering Monmouth (All Protocol Activities)
    Middletown, New Jersey 07748, United States
    Recruiting
    • Meredith Bartelstein, MD · Contact212-639-8684
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
    Montvale, New Jersey 07645, United States
    Recruiting
    • Meredith Bartelstein, MD · Contact212-639-8684
  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
    Commack, New York 11725, United States
    Recruiting
    • Meredith Bartelstein, MD · Contact212-639-8684
  • Memorial Sloan Kettering Westchester (All Protocol Activities)
    Harrison, New York 10604, United States
    Recruiting
    • Meredith Bartelstein, MD · Contact212-639-8684
  • Memorial Sloan Kettering Cancer Center (All protocol activites)
    New York, New York 10065, United States
    Recruiting
    • Meredeith Bartelstein, MD · Contact212-639-8684
  • Memorial Sloan Kettering Nassau (All protocol activities)
    Uniondale, New York 11553, United States
    Recruiting
    • Meredith Bartelstein, MD · Contact212-639-8684
  • William Beaumont Army Medical Center
    Fort Bliss, Texas 79918, United States
    Not yet recruiting
    • Elizabeth M Polfer, MD · Contact915-742-5169
08

References and documents

Individual participant data

Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Nov 2026, 36 months after the start.

Of 144 non-industry interventional studies with no phase under Sarcoma, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 120. This study's planned 36 months is below that.

Counting every sponsor, half of 147 studies reached it within 59 months; a quarter within 34 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2023
First posted
Nov 13, 2023
StartActual
Nov 7, 2023
Primary completionEst.
Nov 7, 2026
CompletionEst.
Nov 7, 2026
Last update
May 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06129903
Responsible party
Sponsor
First posted
Nov 13, 2023
Start date
Nov 7, 2023
Primary completion
Nov 7, 2026 (estimated)
Completion
Nov 7, 2026 (estimated)
Last update
May 15, 2026

Study contacts

Meredith Bartelstein, MD
Contact
bartelsm@mskcc.org
212-639-8684
Yesne Alici, MD
Contact
aliciy@mskcc.org
646-888-0025
Meredith Bartelstein, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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