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

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129903
• Other study ID #: 23-247
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2023
• Est. completion date: November 7, 2026

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Meredith Bartelstein, MD
• Phone: 212-639-8684
• Email: bartelsm[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 7, 2026
• Est. primary completion date: November 7, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Sarcoma
• Osteosarcoma
• Sarcoma
• Soft Tissue Sarcoma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )	Commack	New York
United States	William Beaumont Army Medical Center	Fort Bliss	Texas
United States	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York
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 Cancer Center (All protocol activites)	New York	New York
United States	Memorial Sloan Kettering Nassau (All protocol activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center