Improving Care Delivery for Patients With Mental Illness and Cancer Across a Cancer Center Network
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
The proposed project is an implementation-effectiveness randomized trial of a person-centered collaborative care model for patients with serious mental illness and new cancer. The BRIDGE NET intervention is theoretically informed, pragmatic, and delivered virtually by an interdisciplinary team and includes early psychiatry consultation, integrated oncology and mental health treatment planning and regular patient outreach to adddress barriers to care. The BRIDGE NET intervention addresses the unique needs of patients with mental illness and cancer. To increase the reach of specialty cancer and mental health care, there is a critical need for interventions that can be delivered virtually. This work has can inform the standard of care for patients with serious mental illness and cancer and lay the groundwork for future multi--site trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
be ≥18 years
have a prior diagnosis of SMI, defined as schizophrenia spectrum disorder, bipolar disorder, or major depressive disorder with previous psychiatric hospitalization
have a new primary diagnosis of invasive breast, head/neck, gastrointestinal (GI), genitourinary (GU), thoracic, or gynecological cancers that can be treated with curative intent
be within 8 weeks of initial oncology consultation at or referral to a community cancer affiliate site of the Mass General Brigham Cancer Institute at MGH
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
BRIDGE NET
Other interventionBRIDGE is a 24-week person-centered collaborative care intervention that engages a multidisciplinary team to improve cancer outcomes for patients with SMI and new cancers. Modules include Evaluation, Treatment Planning, Weekly Outreach, Biweekly Outreach, and Transition Planning.
Treatment groups
248 Participants
are divided into 2 treatment groupsGroup A: BRIDGE NET Intervention ArmActive comparator 1 intervention
Group B: Enhanced Usual Care ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Cancer Care Disruption
Primary outcome is the proportion of patients who experience clinically relevant disruptions (at least one delay to cancer treatment initiation, deviation from stage-appropriate cancer treatment, or interruption in planned treatment) within 24 weeks of study enrollment.
Time frame
24 weeksSecondary outcomes
1
Time to cancer treatment initiation
Study staff will assess time to cancer treatment (interval from initial oncology consultation to cancer treatment initiation).
Time frame
Up to 24 weeks2
Depression (PHQ-9)
The PHQ-9 (Patient Health Questionnaire-9) is a standardized, 9-item self-report tool used by healthcare providers to screen for, diagnose, and measure the severity of depression. Higher score indicates more severe depression symptoms (minimum 0, maxiumum 27).
Time frame
Baseline, 6 weeks, 12 weeks, 24 weeks3
Anxiety (GAD-7)
The GAD-7 (Generalized Anxiety Disorder-7) is a brief 7-item questionnaire used by healthcare providers to screen for Generalized Anxiety Disorder and measure the severity of anxiety symptoms. Higher scores indicate higher anxiety symptoms. (Minimum score 0, Maximum score 21).
Time frame
Baseline, 6 weeks, 12 weeks, 24 weeksLocations
Sponsors and contacts
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Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: