RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-11-07

Study Completion:2026-11-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06129903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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

Study Contact

Meredith Bartelstein, MD

CONTACT

212-639-8684

bartelsm@mskcc.org

Yesne Alici, MD

CONTACT

646-888-0025

aliciy@mskcc.org

Principal Investigator

Meredith Bartelstein, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (All protocol activities)

Uniondale, New York, 11553

United States

William Beaumont Army Medical Center

Fort Bliss, Texas, 79918

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Meredith Bartelstein, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-07

Study Completion Date2026-11-07

Study Record Updates

Study Start Date2023-11-07

Study Completion Date2026-11-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Sarcoma
Bone Sarcoma
Soft Tissue Sarcoma