Clinical trial NCT06129903: Study Assessing the Effects of Early Psychiatric Referral on Mental Health and Quality of Life in People With 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcoma
Bone Sarcoma
Soft Tissue Sarcoma
Keywords: Sarcoma
Bone Sarcoma
Soft Tissue Sarcoma
Quality of Life
23-247
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: The number of participants who complete scheduled study visits
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activites)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All protocol activities)
state: New York
city: Fort Bliss
country: United States
facility: William Beaumont Army Medical Center
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Meredith Bartelstein, MD
role: PRINCIPAL_INVESTIGATOR
References: