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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT06129903

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

8.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to see if early psychiatric referral can help to recognize and manage symptoms of depression and anxiety in participants with sarcoma, as well as if it can improve health-related quality of life.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma Bone Sarcoma Soft Tissue Sarcoma	Other: referral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences.

Study Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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

Actual Study Start Date :

Nov 7, 2023

Anticipated Primary Completion Date :

Nov 7, 2026

Anticipated Study Completion Date :

Nov 7, 2026

Arms and Interventions

Arm	Intervention/Treatment
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. 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.
No Referral Participants will be randomized to the No Referral group

Arm

Intervention/Treatment

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.

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.

No Referral

Participants will be randomized to the No Referral group

Outcome Measures

Primary Outcome Measures

The number of participants who complete scheduled study visits [2 years]
This study will evaluate the feasibility of conducting a randomized clinical trial studying the impact of early referral to psychiatry on depression and anxiety symptoms in patients with musculoskeletal sarcoma by adherence endpoint. Adherence rate is defined as the number of participants completing all study requirements divided by the number of participants consented.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥18 years
Tissue diagnosis of primary bone or soft tissue sarcoma
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All protocol activites)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (All protocol activities)	Rockville Centre	New York	United States	11553
8	William Beaumont Army Medical Center	Fort Bliss	Texas	United States	79918