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

Memorial Sloan Kettering Cancer Center8 sites in 1 country60 target enrollmentNovember 7, 2023

ConditionsSarcoma Bone Sarcoma Soft Tissue Sarcoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sarcoma
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 60
Locations: 8
Primary Endpoint: The number of participants who complete scheduled study visits
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 7, 2023

End Date

November 7, 2026

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The number of participants who complete scheduled study visits

Time Frame: 2 years

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.