CancerNCT03360695
Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer
A study testing Proactive Psychiatry Consultation (PPC) in people with Cancer and Severe Major Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Severe Major Depression, Schizophrenia
- What is being tested?
- Proactive Psychiatry Consultation (PPC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2017to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Patient 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
Patient 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Cancer, Severe Major Depression, Schizophrenia, Bipolar Disorder, Lung Cancer, Breast Cancer
- Being tested
- Proactive Psychiatry Consultation (PPC), Enhanced Usual Care (EUC)
- Keywords
- Cancer Care, Major Depression and Cancer, Schizophrenia and Cancer, Bipolar Disorder and Cancer, Lung Cancer, Breast Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Schizophrenia, Bipolar Disorder, Major Depression
- Medical subject headings
- Neoplasms, Depressive Disorder, Major, Schizophrenia, Bipolar Disorder, Lung Neoplasms, Breast Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive Psychiatry Consultation (PPC)Other
Proactive Psychiatry Consultation and Case Management aims to improve communication among the patient, oncology team, and mental health clinicians, and increase engagement of family and community caregivers, which may help patients to receive the cancer care they need.
Enhanced Usual Care (EUC)Other
At enrollment, study staff will inform the treating oncologist of the psychiatric diagnosis and will inform the oncologist, patient, and caregiver of available psychosocial services.
| Study group | Role | What they receive |
|---|---|---|
| Proactive Psychiatry Consultation (PPC) - PILOT | Experimental | Proactive Psychiatry Consultation and Case Management is:
1. Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity.
2. Team-based: A psychiatrist and case manager identify goals for cancer treatment, assess psychiatric history and symptoms with a focus on impact on cancer care, collaborate with community-based clinicians and caregivers, and address barriers to care.
3. Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment.
4. Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed. Receives: Other: Proactive Psychiatry Consultation (PPC) |
| Proactive Psychiatry Consultation (PPC) - Randomized Trial | Experimental | Proactive Psychiatry Consultation and Case Management is:
1. Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity.
2. Team-based: A psychiatrist and case manager identify goals for cancer treatment, assess psychiatric history and symptoms with a focus on impact on cancer care, collaborate with community-based clinicians and caregivers, and address barriers to care.
3. Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment.
4. Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed. Receives: Other: Proactive Psychiatry Consultation (PPC) |
| Enhanced Usual Care (EUC) - Randomized Trial | Active comparator | Study staff will send a templated email to the treating oncologist at enrollment informing the oncologists of the psychiatric diagnosis and available psychosocial services. Study staff will also inform the patient and caregiver of available psychosocial services. Receives: Other: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disruptions in Cancer Care
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).
Measured: 6 months from study enrollment
Secondary outcomes (2)
BPRS (24)
Brief Psychiatric Rating Scale (BPRS) 24
24-item instrument where the rater enters a number for each symptom. Each symptom construct is rated on a Likert scale from 1 (NOT PRESENT) - 7 (EXTREMELY SEVERE). The sum of all 24 items is then calculated to a maximum score of 168 (24X7=168). The minimum score is 24 and the maximum score is 168. The higher the score, the more psychiatrically impaired the patient is. Higher scores mean worse psychiatric symptoms.
Measured: Week 0, Week 12, Week 24
PHQ-9
Patient Health Questionnaire-9 is a 9-item instrument that measures patient depression where a score of 1-4 indicates minimal depression, 5-9 Mild depression, 10-14 Moderate depression, 15-19 Moderately severe depression, 20-27 Severe depression. The minimum score is 1 and the maximum score is 27.
Measured: Week 0, Week 6, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start11 Dec 2017
- Primary completion8 Nov 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Risk Management Foundation, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kelly Edwards Irwin, Massachusetts General Hospital
- Investigators
- Kelly E Irwin, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360695
- Sponsor's protocol ID
- 17-396
- Other IDs
- 1K08CA230185-01
- Status last verified
- Feb 2024
- First submitted
- 28 Nov 2017
- Last updated
- 8 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Irwin KE, Callaway CA, Corveleyn AE, Pappano CR, Barry MJ, Tiersma KM, Nelson ZE, Fields LE, Pirl WF, Greer JA, Temel JS, Ryan DP, Nierenberg AA, Park ER. Study protocol for a randomized trial of bridge: Person-centered collaborative care for serious mental illness and cancer. Contemp Clin Trials. 2022 Dec;123:106975. doi: 10.1016/j.cct.2022.106975. Epub 2022 Oct 25.
PubMed 36307008
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer
- ClinicalTrials.gov ID
- NCT03360695
- Acronym / sponsor ID
- 17-396
- Conditions
- Cancer, Severe Major Depression, Schizophrenia, Bipolar Disorder, Lung Cancer, Breast Cancer
- Keywords
- Cancer Care, Major Depression and Cancer, Schizophrenia and Cancer, Bipolar Disorder and Cancer, Lung Cancer, Breast Cancer, Head and Neck Cancer, Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Harvard Risk Management Foundation, National Cancer Institute (NCI)
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Posted 8 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Proactive Psychiatry Consultation (PPC) - PILOT | Experimental | Other: Proactive Psychiatry Consultation (PPC)Proactive Psychiatry Consultation and Case Management is: 1. Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity. 2. Team-based: A psychiatrist and case manager identify goals for cancer treatment, assess psychiatric history and symptoms with a focus on impact on cancer care, collaborate with community-based clinicians and caregivers, and address barriers to care. 3. Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment. 4. Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed. |
| Proactive Psychiatry Consultation (PPC) - Randomized Trial | Experimental | Other: Proactive Psychiatry Consultation (PPC)Proactive Psychiatry Consultation and Case Management is: 1. Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity. 2. Team-based: A psychiatrist and case manager identify goals for cancer treatment, assess psychiatric history and symptoms with a focus on impact on cancer care, collaborate with community-based clinicians and caregivers, and address barriers to care. 3. Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment. 4. Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed. |
| Enhanced Usual Care (EUC) - Randomized Trial | Active comparator | Other: Enhanced Usual Care (EUC)Study staff will send a templated email to the treating oncologist at enrollment informing the oncologists of the psychiatric diagnosis and available psychosocial services. Study staff will also inform the patient and caregiver of available psychosocial services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Proactive Psychiatry Consultation (PPC)Proactive Psychiatry Consultation and Case Management aims to improve communication among the patient, oncology team, and mental health clinicians, and increase engagement of family and community caregivers, which may help patients to receive the cancer care they need. | Other | Proactive Psychiatry Consultation (PPC) - PILOT, Proactive Psychiatry Consultation (PPC) - Randomized Trial |
| Enhanced Usual Care (EUC)At enrollment, study staff will inform the treating oncologist of the psychiatric diagnosis and will inform the oncologist, patient, and caregiver of available psychosocial services. | Other | Enhanced Usual Care (EUC) - Randomized Trial |
Primary outcome
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).
2 secondary outcomes
BPRS (24)
Time frame: Week 0, Week 12, Week 24
PHQ-9
Time frame: Week 0, Week 6, Week 12, Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36307008Irwin KE, Callaway CA, Corveleyn AE, Pappano CR, Barry MJ, Tiersma KM, Nelson ZE, Fields LE, Pirl WF, Greer JA, Temel JS, Ryan DP, Nierenberg AA, Park ER. Study protocol for a randomized trial of bridge: Person-centered collaborative care for serious mental illness and cancer. Contemp Clin Trials. 2022 Dec;123:106975. doi: 10.1016/j.cct.2022.106975. Epub 2022 Oct 25.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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. This study is not recruiting at the moment.
Kelly E Irwin, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive Psychiatry Consultation (PPC) in people with Cancer and Severe Major Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 8 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disruptions in Cancer Care (time frame: 6 months from study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03360695, which also lists 1 linked publication.
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 8 Feb 2024.