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Clinical Trials/NCT03360695
NCT03360695
Completed
N/A

Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer

Massachusetts General Hospital1 site in 1 country185 target enrollmentDecember 11, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
Massachusetts General Hospital
Enrollment
185
Locations
1
Primary Endpoint
Disruptions in Cancer Care
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this research is to understand if it is helpful for patients with mental illness to be connected to a psychiatrist and case manager at the time of cancer diagnosis.

Detailed Description

It is challenging to cope with cancer. The investigators want to understand if it is helpful for patients with serious mental illness (SMI) to be connected to a psychiatrist and case manager when cancer is diagnosed. Many people with illnesses like major depression, schizophrenia and bipolar disorder face barriers to receiving high quality cancer care. It can be difficult to get to appointments, have many different doctors, and experience depression or worry. Better communication between the patient, the oncology team, and mental health providers may improve care. As for all patients, it is important for people with mental illness to have access to high quality cancer treatment that is patient-centered and coordinated. Having a case manager and psychiatrist at the cancer center who collaborates with the oncology team starting at cancer diagnosis may help patients to receive the cancer care that they need. This study includes a single-arm open pilot (n=8) to pilot patient and caregiver measures and refine the intervention manual; a run-in period (n=6) to pilot the randomized trial procedures; and a randomized controlled trial (n=120) to compare the impact of the Bridge model with enhanced usual care on disruptions in cancer care.

Registry
clinicaltrials.gov
Start Date
December 11, 2017
End Date
December 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kelly Edwards Irwin

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years old; Value ______
  • Verbal fluency in English
  • Serious mental illness (Schizophrenia spectrum disorder, bipolar disorder, or major depressive disorder with prior psychiatric hospitalization) confirmed by study clinician at consent
  • Invasive breast, lung, gastrointestinal, or head and neck cancer (suspected or confirmed Stage I-III, or Stage IV cancer that can be treated with curative intent according to judgment by the oncologist.)
  • Medical, surgical, or radiation oncology consultation at MGH Cancer Center within the past 8 weeks or a referral placed to the MGH Cancer Center and planned or recommended follow-up

Exclusion Criteria

  • Have cognitive impairment severe enough to interfere with completing brief study assessments or providing informed consent (and does not have a guardian who can provide consent)
  • Recurrence of the same cancer type
  • Caregiver Participants
  • Age ≥ 18 years old; Value ______
  • Verbal fluency in English
  • Identified or confirmed by the patient or guardian as a caregiver
  • Caregiver may be a relative, friend, or community mental health staff upon whom the patient relies upon for support and who accompanies the patient to medical appointments
  • The caregiver should either live with the patient or have in-person contact with the patient once per week (on average)
  • Patient or guardian must provide permission to contact caregiver

Outcomes

Primary Outcomes

Disruptions in Cancer Care

Time Frame: 6 months from study enrollment

The number of patients who experience clinically relevant disruptions in cancer care (e.g. delay to cancer diagnosis or treatment, deviation from stage-appropriate cancer treatment, or interruption in planned treatment).

Secondary Outcomes

  • PHQ-9(Week 0, Week 6, Week 12, Week 24)
  • BPRS (24)(Week 0, Week 12, Week 24)

Study Sites (1)

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