Bipolar Disorder, Breast Cancer, Cancer, Gastrointestinal Cancer, Head and Neck Cancer, Lung Cancer, Schizophrenia, Severe Major Depression
Conditions
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
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.
Interventions
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.
OTHEREnhanced 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.
Sponsors
Harvard Risk Management Foundation
National Cancer Institute (NCI)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
1\. A consensus panel of disease-specific oncologists who are blinded to intervention arm will review all patients at 24 weeks of care and evaluate for disruptions in cancer care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disruptions in Cancer Care | 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
| Measure | Time frame | Description |
|---|---|---|
| BPRS (24) | Week 0, Week 12, Week 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. |
| PHQ-9 | Week 0, Week 6, Week 12, Week 24 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Usual Care (EUC) - Randomized Trial 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.
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. | 60 |
| Proactive Psychiatry Consultation (PPC) - Randomized Trial 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): 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. | 60 |
| Enhanced Usual Care (EUC) - Randomized Trial - CAREGIVERS Enrolled caregivers of patients randomized to Enhanced Usual Care (EUC) arm of Randomized Trial. | 32 |
| Proactive Psychiatry Consultation (PPC) - Randomized Trial - CAREGIVERS Enrolled caregivers of patients randomized to Proactive Psychiatry Consultation (PPC) arm of Randomized Trial. | 33 |
| Total | 185 |
Baseline characteristics
| Characteristic | Proactive Psychiatry Consultation (PPC) - Randomized Trial | Total | Enhanced Usual Care (EUC) - Randomized Trial | Proactive Psychiatry Consultation (PPC) - Randomized Trial - CAREGIVERS | Enhanced Usual Care (EUC) - Randomized Trial - CAREGIVERS |
|---|---|---|---|---|---|
| Age, Continuous | 60.6 years STANDARD_DEVIATION 11.8 | 61.3 years STANDARD_DEVIATION 12.4 | 62.0 years STANDARD_DEVIATION 13.2 | — | — |
| Cancer Diagnosis Breast | 20 Participants | 34 Participants | 14 Participants | — | — |
| Cancer Diagnosis Gastrointestinal | 10 Participants | 30 Participants | 20 Participants | — | — |
| Cancer Diagnosis Head & Neck | 14 Participants | 28 Participants | 14 Participants | — | — |
| Cancer Diagnosis Lung | 16 Participants | 28 Participants | 12 Participants | — | — |
| Caregiver Enrolled Caregiver enrolled | 33 Participants | 65 Participants | 32 Participants | — | — |
| Caregiver Enrolled No caregiver enrolled | 27 Participants | 55 Participants | 28 Participants | — | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 176 Participants | 56 Participants | 32 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 6 Participants | 3 Participants | 1 Participants | 0 Participants |
| Psychiatrist Has psychiatrist | 25 Participants | 59 Participants | 34 Participants | — | — |
| Psychiatrist No psychiatrist | 35 Participants | 61 Participants | 26 Participants | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 50 Participants | 164 Participants | 55 Participants | 31 Participants | 28 Participants |
| Region of Enrollment United States | 60 participants | 120 participants | 60 participants | 33 participants | 32 participants |
| Relationship to Patient Divorced / separated | — | 1 Participants | — | 0 Participants | 1 Participants |
| Relationship to Patient Family member | — | 23 Participants | — | 14 Participants | 9 Participants |
| Relationship to Patient Friend | — | 2 Participants | — | 1 Participants | 1 Participants |
| Relationship to Patient Married / Living as if married | — | 28 Participants | — | 14 Participants | 14 Participants |
| Relationship to Patient Non-cohabitating relationship | — | 4 Participants | — | 1 Participants | 3 Participants |
| Relationship to Patient Other | — | 1 Participants | — | 1 Participants | 0 Participants |
| Relationship to Patient Work with through community mental health | — | 6 Participants | — | 2 Participants | 4 Participants |
| Severe Mental Illness Diagnosis Bipolar Depression | 22 Participants | 47 Participants | 25 Participants | — | — |
| Severe Mental Illness Diagnosis Depression | 26 Participants | 50 Participants | 24 Participants | — | — |
| Severe Mental Illness Diagnosis Schiz Spectrum Disorder | 12 Participants | 23 Participants | 11 Participants | — | — |
| Sex/Gender, Customized Female | 45 Participants | 123 Participants | 33 Participants | 21 Participants | 24 Participants |
| Sex/Gender, Customized Fluid / Non-Binary | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Male | 15 Participants | 60 Participants | 25 Participants | 12 Participants | 8 Participants |
| Sex/Gender, Customized Missing | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 57 | 4 / 58 |
| other Total, other adverse events | 0 / 57 | 0 / 58 |
| serious Total, serious adverse events | 0 / 57 | 0 / 58 |
Outcome results
Primary
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).
Time frame: 6 months from study enrollment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Usual Care (EUC) - Randomized Trial | Disruptions in Cancer Care | Any Disruption | 37 Participants |
| Enhanced Usual Care (EUC) - Randomized Trial | Disruptions in Cancer Care | No Disruption | 20 Participants |
| Proactive Psychiatry Consultation (PPC) - Randomized Trial | Disruptions in Cancer Care | Any Disruption | 48 Participants |
| Proactive Psychiatry Consultation (PPC) - Randomized Trial | Disruptions in Cancer Care | No Disruption | 10 Participants |
Secondary
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.
Time frame: Week 0, Week 12, Week 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care (EUC) - Randomized Trial | BPRS (24) | Week 0 | 46.51 score on a scale | Standard Deviation 11.25 |
| Enhanced Usual Care (EUC) - Randomized Trial | BPRS (24) | Week 12 | 43.06 score on a scale | Standard Deviation 12.71 |
| Enhanced Usual Care (EUC) - Randomized Trial | BPRS (24) | Week 24 | 46.1 score on a scale | Standard Deviation 14.03 |
| Proactive Psychiatry Consultation (PPC) - Randomized Trial | BPRS (24) | Week 0 | 47.44 score on a scale | Standard Deviation 13.76 |
| Proactive Psychiatry Consultation (PPC) - Randomized Trial | BPRS (24) | Week 12 | 44.96 score on a scale | Standard Deviation 12.26 |
| Proactive Psychiatry Consultation (PPC) - Randomized Trial | BPRS (24) | Week 24 | 41.22 score on a scale | Standard Deviation 10.31 |
Secondary
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.
Time frame: Week 0, Week 6, Week 12, Week 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care (EUC) - Randomized Trial | PHQ-9 | Week 0 | 9.67 score on a scale | Standard Deviation 6.02 |
| Enhanced Usual Care (EUC) - Randomized Trial | PHQ-9 | Week 6 | 9.60 score on a scale | Standard Deviation 5.98 |
| Enhanced Usual Care (EUC) - Randomized Trial | PHQ-9 | Week 12 | 9.78 score on a scale | Standard Deviation 6.25 |
| Enhanced Usual Care (EUC) - Randomized Trial | PHQ-9 | Week 24 | 8.05 score on a scale | Standard Deviation 6.34 |
| Proactive Psychiatry Consultation (PPC) - Randomized Trial | PHQ-9 | Week 24 | 6.93 score on a scale | Standard Deviation 5.5 |
| Proactive Psychiatry Consultation (PPC) - Randomized Trial | PHQ-9 | Week 0 | 9.09 score on a scale | Standard Deviation 6.72 |
| Proactive Psychiatry Consultation (PPC) - Randomized Trial | PHQ-9 | Week 12 | 7.72 score on a scale | Standard Deviation 5.77 |
| Proactive Psychiatry Consultation (PPC) - Randomized Trial | PHQ-9 | Week 6 | 7.89 score on a scale | Standard Deviation 5.43 |