CancerBRIDGE-NETNCT07707362
Improving Care Delivery for Patients With Mental Illness and Cancer Across a Cancer Center Network
A study testing BRIDGE NET in people with Cancer and Serious Mental Illness, run by Massachusetts General Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Serious Mental Illness
- What is being tested?
- BRIDGE NET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- be able to read and write in English, Spanish, or Portuguese
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cancer, Serious Mental Illness
- Being tested
- BRIDGE NET
- Keywords
- Cancer, Serious mental illness, Collaborative care model
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRIDGE NETOther
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.
| Study group | Role | What they receive |
|---|---|---|
| BRIDGE NET Intervention Arm | Active comparator | 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. Receives: Other: BRIDGE NET |
| Enhanced Usual Care Arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (3)
Time to cancer treatment initiation
Study staff will assess time to cancer treatment (interval from initial oncology consultation to cancer treatment initiation).
Measured: Up to 24 weeks
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).
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
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).
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a hybrid type I effectiveness-implementation randomized trial to evaluate the efficacy of the BRIDGE-NET intervention which combines features of a Phase II and Phase III trial given analysis of intervention outcomes and implementation outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kelly Edwards Irwin, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707362
- Sponsor's protocol ID
- R37CA300110
- Other IDs
- R37CA300110
- Acronym
- BRIDGE-NET
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care Delivery for Individuals With Mental Illness and Cancer Across a Cancer Center Network: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07707362
- Acronym / sponsor ID
- BRIDGE-NET / R37CA300110
- Conditions
- Cancer, Serious Mental Illness
- Keywords
- Cancer, Serious mental illness, Collaborative care model
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a hybrid type I effectiveness-implementation randomized trial to evaluate the efficacy of the BRIDGE-NET intervention which combines features of a Phase II and Phase III trial given analysis of intervention outcomes and implementation outcomes.
| Arm | Type | Receives |
|---|---|---|
| BRIDGE NET Intervention Arm | Active comparator | Other: BRIDGE NETBRIDGE 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. |
| Enhanced Usual Care Arm | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- be able to read and write in English, Spanish, or Portuguese
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRIDGE NETBRIDGE 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. | Other | BRIDGE NET Intervention Arm |
Primary outcome
Cancer Care Disruption
Time frame: 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.
3 secondary outcomes
Time to cancer treatment initiation
Time frame: Up to 24 weeks
Depression (PHQ-9)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Anxiety (GAD-7)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing BRIDGE NET in people with Cancer and Serious Mental Illness, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Irwin, MD, MPH (617-726-2000, kirwin1@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer Care Disruption (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.