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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether early mental health care can be offered during sarcoma treatment. Sarcoma is cancer that starts in bone or soft tissue. The study is for adults having surgery and looks at links between early mental health care and depression, anxiety, recovery after surgery, and satisfaction with care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • A tissue test shows sarcoma that started in bone or soft tissue. You may also qualify if your history and scans strongly suggest sarcoma and the lead study doctor approves.
  • You are seeing the bone and joint surgery team.
  • Your treatment plan includes surgery at MSK to treat the original sarcoma.
  • You have not had treatment for sarcoma before.
  • You answer that you speak English “very well,” and English is your preferred language for talking about health care.

Who can't join

  • The study doctor decides that a serious mental health problem would prevent you from taking part. Examples include severe mental illness, past suicide attempts, or past hospital stays for mental health care.
  • When you are assigned to a study group, you have an urgent mental health need or emergency that needs evaluation. This is based on a suicide-risk screening score or the bone and joint doctor's judgment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (8)

NJ

NY

TX