What this study is
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.
What's being tested
- referral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences.
Intervention · OTHER
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.
Study details
- Official title
- 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
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Sarcoma · Bone Sarcoma · Soft Tissue Sarcoma
- Enrolling
- 60 people
- Starts
- 2023-11-07
- Est. completion
- 2026-11-07
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (8)
8 openContact for 6 of 8 open sites
- Meredith Bartelstein, MD · Contact212-639-8684
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
RecruitingMemorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
RecruitingMemorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
RecruitingMemorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
Commack, New York, United States
RecruitingMemorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States
RecruitingMemorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, United States
- Meredeith Bartelstein, MD · Contact212-639-8684
RecruitingMemorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, United States
RecruitingWilliam Beaumont Army Medical Center
Fort Bliss, Texas, United States
- Elizabeth M Polfer, MD · Contact915-742-5169
Not yet recruiting
Study team
Sponsor
Memorial Sloan Kettering Cancer Center
Study ID 23-247
Principal investigator
Meredith Bartelstein, MD
Memorial Sloan Kettering Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.