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Improving Care Delivery for Patients With Mental Illness and Cancer Across a Cancer Center Network (BRIDGE-NET)

15. juli 2026 oppdatert av: Kelly Edwards Irwin, Massachusetts General Hospital

Improving Care Delivery for Individuals With Mental Illness and Cancer Across a Cancer Center Network: A Randomized 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a hybrid type I effectiveness-implementation randomized trial to evaluate the efficacy of the BRIDGE NET intervention. The proposed project addresses multiple modifiable disparities in cancer treatment and outcomes for a marginalized population of adults with SMI, who experience inequities in cancer treatment. The BRIDGE NET intervention is theoretically informed, pragmatic, and able to be delivered virtually by a diverse clinical team. Informed by qualitative interviews with clinicians and collaboration with a community advisory board, the investigators rigorously developed, piloted and tested the BRIDGE NET intervention and tailored the approach to the unique needs of patients with SMI and cancer. To increase the reach of specialty care and the limited mental health workforce, there is a critical need for interventions that can be delivered virtually. This work has potential to be foundational for future multi-site trials across national community oncology research networks.

Studietype

Intervensjonell

Registrering (Antatt)

248

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Kelly Irwin, MD, MPH
  • Telefonnummer: 617-726-2000
  • E-post: kirwin1@mgb.org

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. be ≥18 years
  2. have a prior diagnosis of SMI, defined as schizophrenia spectrum disorder, bipolar disorder, or major depressive disorder with previous psychiatric hospitalization
  3. 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
  4. 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
  5. be able to read and write in English, Spanish, or Portuguese

Exclusion Criteria:

-

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: BRIDGE NET Intervention Arm
BRIDGE NET 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.
Annen: BRIDGE NET
BRIDGE 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.
Ingen inngripen: Enhanced Usual Care Arm
EUC includes proactive identification of patients with SMI and a new cancer diagnosis, sending a templated email to the oncologist describing the patient's primary psychiatric diagnosis (e.g. schizophrenia, bipolar disorder, or major depression), and informing the patient of psychosocial services.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cancer Care Disruption
Tidsramme: 24 weeks
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.
24 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to cancer treatment initiation
Tidsramme: Up to 24 weeks
Study staff will assess time to cancer treatment (interval from initial oncology consultation to cancer treatment initiation).
Up to 24 weeks
Depression (PHQ-9)
Tidsramme: Baseline, 6 weeks, 12 weeks, 24 weeks
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).
Baseline, 6 weeks, 12 weeks, 24 weeks
Anxiety (GAD-7)
Tidsramme: Baseline, 6 weeks, 12 weeks, 24 weeks
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).
Baseline, 6 weeks, 12 weeks, 24 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Massachusetts General Hospital

Samarbeidspartnere

National Cancer Institute (NCI)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

31. januar 2030

Studiet fullført (Antatt)

31. juli 2030

Datoer for studieregistrering

Først innsendt

6. juli 2026

Først innsendt som oppfylte QC-kriteriene

15. juli 2026

Først lagt ut (Faktiske)

16. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R37CA300110 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

If the results of this research study are published in a medical journal, they will not identify individual patients in the interest of protecting patient privacy and confidentiality.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på BRIDGE NET

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

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Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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