Trial Title:
Study Assessing the Effects of Early Psychiatric Referral on Mental Health and Quality of Life in People with Sarcoma
NCT ID:
NCT06129903
Condition:
Sarcoma
Bone Sarcoma
Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
Osteosarcoma
Conditions: Keywords:
Sarcoma
Bone Sarcoma
Soft Tissue Sarcoma
Quality of Life
23-247
Memorial Sloan Kettering Cancer Center
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
referral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences.
Description:
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.
Arm group label:
Early Psychiatric Referral
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Meredith Bartelstein, MD
Phone:
212-639-8684
Facility:
Name:
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Meredith Bartelstein, MD
Phone:
212-639-8684
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Meredith Bartelstein, MD
Phone:
212-639-8684
Facility:
Name:
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Meredith Bartelstein, MD
Phone:
212-639-8684
Facility:
Name:
Memorial Sloan Kettering Westchester (All Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Meredith Bartelstein, MD
Phone:
212-639-8684
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All protocol activites)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Meredeith Bartelstein, MD
Phone:
212-639-8684
Facility:
Name:
Memorial Sloan Kettering Nassau (All protocol activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Meredith Bartelstein, MD
Phone:
212-639-8684
Facility:
Name:
William Beaumont Army Medical Center
Address:
City:
Fort Bliss
Zip:
79918
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Elizabeth M Polfer, MD
Phone:
(915) 742-5169
Start date:
November 7, 2023
Completion date:
November 7, 2026
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06129903
http://www.mskcc.org
