Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Breast Neoplasms

Depression

Depressive Disorder

Mental Disorders

Bipolar Disorder

Depressive Disorder, Major

Schizophrenia

Head and Neck Neoplasms

Psychotic Disorders

Behavioral Symptoms

Mood Disorders

Schizophrenia Spectrum and Other Psychotic Disorders

Bipolar and Related Disorders

The patient is linked to a psychiatrist and case manager at cancer diagnosis who deliver team-based, patient-centered care. The psychiatrist collaborates with the oncologist to guide cancer treatment. The psychiatrist and case manager proactively monitor patient symptoms and potential barriers to care and remain in communication with the patient, oncology team, and community-based providers for the duration of the intervention.

* Patients complete study assessments at baseline, 4 +/- 2 weeks after baseline, and post-intervention (12 +/-2 weeks after baseline)
* Oncologists provide feedback about the usefulness of the intervention (12 +/- 2 weeks after baseline)

* The psychiatrist conducts a tailored, cancer-specific assessment to optimize psychiatric symptoms and collaborates with the oncologist to develop and modify the cancer treatment plan.
* The case manager, a social worker, engages with the patient to promote self-management, identify and address barriers to care, and bridge communication with oncology and mental health.
* The psychiatrist and case manager proactively monitor symptoms and the process of cancer care, remain in regular contact with the patient and communicate with the oncology team at least every 4 weeks
* The psychiatrist and case manager are available for consultation across care settings (outpatient, inpatient, home).
* Recommendations are documented in the medical record and communicated directly to the oncology team

Proactive Psychiatry Consultation (PPC)

Kelly Irwin, MD

Individuals with severe mental illness (SMI) including schizophrenia and bipolar disorder are dying younger than the general population; cancer is a leading cause of death in this population. People with SMI have higher rates of dying from breast, lung, and colon cancer, and disparities in treatment appear to be one contributing factor. Individuals with SMI may be diagnosed with more advanced stage cancer and less likely to receive stage-appropriate cancer treatment. Although collaborative care models integrating medical and psychiatric care have shown promise in other populations, the challenge of treating SMI and cancer is distinct and relatively understudied. Patients may have uncontrolled psychiatric symptoms that can impact their understanding of their diagnosis and treatment decisions. Oncologists have less training and inadequate time to address multiple unmet needs. Mental health care is frequently fragmented from cancer care.

The investigators want to understand if it is helpful for patients with SMI to be connected to a psychiatrist and case manager when cancer is diagnosed. Optimizing psychiatric symptoms and facilitating communication between the patient, the oncology team, and mental health providers may improve care. The goal is to pilot a pragmatic intervention for patients with cancer and SMI that can be integrated into cancer care, is acceptable to patients and oncology clinicians, and may promote the delivery of stage-appropriate cancer treatment to an underserved population.

Patients will be connected to a psychiatrist and case manager at cancer diagnosis who will follow the patient and communicate with the oncology team during the 12 week intervention. All participants will complete brief surveys at baseline, 4 weeks, and 12 weeks. Oncology clinicians will provide feedback about the intervention at 12 weeks. Cancer treatment received and healthcare utilization will be assessed at 6 months post-intervention.

Specific Aims:

Aim 1: To evaluate the feasibility and acceptability of proactive psychiatry consultation and case management among individuals with SMI treated at the MGH Cancer Center and their oncology clinicians.

Aim 2: To describe the rates of receipt of stage-appropriate cancer treatment and patterns of healthcare utilization in patients with SMI and cancer who are receiving the intervention

Aim 3: To explore patterns of change in psychiatric symptoms, quality of life, illness understanding, and alliance with the oncology clinician in patients with SMI and a recent cancer diagnosis who are receiving the intervention.

Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness

Feasibility of participating in the intervention:

* At least 75% of intervention participants complete the psychiatric diagnostic assessment and establish contact with the case manager
* At least 75% of enrolled patients complete the patient-reported measures.

Feasibility of enrollment process:

• At least 50% of patients who are approached enroll in the intervention

Study acceptability will be evaluated via exit interviews with oncology clinicians and study participants regarding the content, timing, and usefulness of the intervention.

Rates of receipt of stage-appropriate cancer treatment measured by medical record review and feedback from oncology clinician at 6 months post intervention

Rates of healthcare utilization in outpatient setting measured by medical record review at 6 months post intervention

Rates of healthcare utilization in acute care setting (aggregate measure of emergency visits and hospitalizations) measured by medical record review at 6 months post intervention

- Psychiatric symptom severity according to the Behavioral Psychiatric Rating Scale (BPRS) pre and 12 weeks post intervention

- Psychiatric illness severity according to the Clinical Global Impression-Severity (CGI-S) scale pre-intervention, 4 weeks post intervention, and 12 weeks post intervention

- Self reported psychiatric symptoms according to the Behavior and Symptoms Identification Scale (BASIS) pre, 4 weeks post intervention, and 12 weeks post intervention

- Self-reported severity of depression according to the Patient Health Questionnaire-9 (PHQ-9) pre, 4 weeks post-intervention, and 12 weeks post-intervention

-Quality of life according to the Functional Assessment of Cancer Therapy-General (FACT-G)pre, 4 weeks post intervention, and 12 weeks post intervention

Self-reported illness understanding according to the Prognosis and Treatment Perceptions Questionnaire at baseline and 12 weeks post intervention

Self-reported alliance with the oncology clinician according to the Human Connection Scale at baseline and 12 weeks post intervention

American Cancer Society, Inc.

National Cancer Institute (NCI)

Massachusetts General Hospital

Instructor, Harvard Medical School

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Urogenital Neoplasms

Gastrointestinal Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

This intervention has three parts:

Part 1: Proactive identification and assessment of patient needs, values, psychiatric symptoms, and illness understanding

Part 2: Virtual tumor board discussion

o Bring together expertise in mental illness and cancer, the interdisciplinary team will co-design an integrated cancer and mental health treatment plan. Key strategies include: addressing resource-related barriers to care, framing next steps in terms of patient values, and identifying action steps to address barriers to psycho-oncology/specialty oncology expertise

Part 3: Closed Loop Communication

o Tumor board recommendations shared with treating oncologist, documented in medical record, and shared with patient. Team tracks steps taken to address barriers to care and follows up with patient at 12 weeks.

The Virtual Cancer and Mental Health Tumor Board intervention aims to increase access to psycho-oncology and oncology expertise, facilitate clinician communication, build understanding of the person's needs and strengths, and address barriers to care. Strategies include a proactive assessment of illness understanding, psychiatric history, and barriers to care followed by development of an integrated cancer and mental health treatment plan during the tumor board session that is framed in terms of patient values and addresses barriers to accessing psycho-oncology and specialty oncology expertise. These recommendations will be shared with treating oncologists, documented in the medical record, and shared with the patient. Patients will receive a transition phone call at 12 weeks.

Virtual Cancer and Mental Health Tumor Board

Kelly Irwin, MD, MPH

Elizabeth P Walsh, MD

This study examines the feasibility and acceptability of a virtual tumor board for cancer and mental illness for patients with serious mental illness and a new cancer diagnosis. The study also examines the impact on patient care, psychiatric symptoms, and clinician self-efficacy in managing this population.

Individuals with serious mental illness (SMI) experience increased cancer mortality because of inequities in cancer care. Access to mental health and cancer care remains inadequate. Virtual tumor boards have been associated with higher rates of patients receiving guideline-concordant cancer care, but these tumor boards have not been adapted for cancer and mental illness. A virtual cancer and mental health tumor board intervention has potential to increase access to psycho-oncology and oncology expertise, facilitate clinician communication, and may address barriers to cancer and mental health care. The purpose of this study is to examine the feasibility and acceptability of a virtual tumor board for cancer and mental illness for our target population for patients and clinicians. We will also explore changes in cancer care, psychiatric symptoms, and clinician self-efficacy in managing this population. This study is a single-arm pilot (n = 30) based at a cancer center affiliate and the surrounding community. The intervention includes proactive identification using a registry, bi-monthly virtual equity tumor board focused on cancer and mental health using HIPAA-compliant videoconference that uses co-learning, assessment of barriers to cancer care, strengths, and goals of care, creating plans that identify who is responsible for next steps and patient communication, and relaying recommendations to patients and the treating oncology team.

Adapting the Tumor Board Model for Mental Illness and Cancer

Adapting the Tumor Board Model for Mental Illness and Cancer: A Single Arm Pilot Trial

Investigators will assess change in patient psychiatric illness severity using the Brief Psychiatric Rating Scale (BPRS). This questionnaire is 24 items, each question rated on a 7-point scale of severity ranging from "not present" to "extremely severe." Scores vary from 24 to 168 with higher scores indicating more severe psychiatric illness.

Investigators will assess change in patient anxiety symptoms using the Generalized Anxiety Disorder-7 (GAD-7). This questionnaire is 7 items, and responses range from "0" (not at all) to "3" (nearly every day), and scores range from 0 to 21, with higher scores indicating greater anxiety.

Investigators will assess change in patient depression symptoms using the Patient Health Questionnaire-9 (PHQ-9). This questionnaire is 9 items, and responses range from "0" (not at all) to "3" (nearly every day), and scores range from 0 to 27, with higher scores indicating greater depression.

Investigators will assess change in patient quality of life using the Functional Assessment of Cancer Therapy - General (FACT-G). This questionnaire is 27 items, and response are on a 5-point rating scale from "0" (not at all) to "4" (very much). Scores range from 0 - 108, and higher scores indicate better quality of life.

Investigators will assess change in tumor board participant self-efficacy using the Tumor Board Participant Self-Efficacy Assessment. This questionnaire is 22 items, with scores ranging from 0 - 44, and higher scores indicating more self-efficacy.

Investigators will assess change in tumor board participant burnout using a modified Maslach Burnout Inventory survey. This questionnaire is 22 items, and responses range from "0" (never) to "6" (every day). Section A scores range from 0 - 42, with a higher score indicating more burnout. Section B scores range from 0 - 42, with a higher score indicating more burnout. Section C scores range from 0 - 48, with a higher score indicating less burnout.

Number of participants with Disruptions in patient cancer care assessed by electronic medical record review. Disruptions are defined as delays, deviations in cancer care recommended, and interruptions in planned cancer treatment.

Number of participants with documented receipt of mental health care for patients assessed by electronic medical record review.

The investigators will evaluate program feasibility through patient enrollment by examining consent rates (60% of eligible patients consent).

The investigators will evaluate trial completion assessed by number of patients who complete study assessments and trial procedures (75% of patient participants have baseline targeted assessment, have tumor board recommendations communicated with them, and complete 12-week assessment of psychiatric symptoms and barriers to cancer care).

The investigators will evaluate program acceptability through patient intervention satisfaction by a patient feedback questionnaire (exit interview surveys with participating patients regarding the usefulness of the intervention) at 12 weeks.

The investigators will evaluate program feasibility by tracking volume of tumor board session attendance (feasibility defined as participants attending 80% of sessions when patients/clients discussed).

The investigators will evaluate program acceptability by examining participant intervention satisfaction (feedback questionnaire at end of study period regarding the acceptability and helpfulness of the virtual tumor board model).

The investigators will evaluate program feasibility by examining the amount of multi-disciplinary representation at tumor board sessions (\>70% of sessions include representation from oncology/cancer center affiliate, community mental health, and psycho-oncology).

The investigators will evaluate program feasibility by tracking percentage of tumor board participants participating in tumor board sessions (80% of participants complete intra-session feedback questionnaire).

The investigators will evaluate program feasibility by examining completion of study measures (70% of participants complete 12-week- and 24-week measures).

The investigators will evaluate program acceptability by examining participant intervention satisfaction (in-session feedback questionnaire regarding the acceptability and helpfulness of the virtual tumor board model).

Trefler Foundation

Principal Investigator

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.

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.

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.

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.

Enhanced Usual Care (EUC)

Kelly E Irwin, MD

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.

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.

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.

Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer

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).

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.

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.

Harvard Risk Management Foundation

Adverse Event data was not collected for caregivers.

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.

Enhanced Usual Care (EUC) - 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.

Proactive Psychiatry Consultation (PPC) - Randomized Trial

Enrolled caregivers of patients randomized to Enhanced Usual Care (EUC) arm of Randomized Trial.

Enhanced Usual Care (EUC) - Randomized Trial - CAREGIVERS

Enrolled caregivers of patients randomized to Proactive Psychiatry Consultation (PPC) arm of Randomized Trial.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness	NCT02594696	Major Depressio... Schizophrenia Bipolar Disorde... Lung Cancer Breast Cancer Head and Neck C... GI Cancer Cancer	Proactive Psych...	18 Years -	Massachusetts General Hospital
Adapting the Tumor Board Model for Mental Illness and Cancer	NCT05837598	Cancer Severe Major De... Schizophrenia Bipolar Disorde... Lung Cancer Breast Cancer Head and Neck C... Gastrointestina... Genitourinary C...	Virtual Cancer ...	18 Years -	Massachusetts General Hospital
Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer	NCT03360695	Cancer Severe Major De... Schizophrenia Bipolar Disorde... Lung Cancer Breast Cancer Head and Neck C... Gastrointestina...	Proactive Psych... Enhanced Usual ...	18 Years -	Massachusetts General Hospital
Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer	NCT03360695	Cancer Severe Major De... Schizophrenia Bipolar Disorde... Lung Cancer Breast Cancer Head and Neck C... Gastrointestina...	Proactive Psych... Enhanced Usual ...	18 Years -	Massachusetts General Hospital
Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness	NCT02594696	Major Depressio... Schizophrenia Bipolar Disorde... Lung Cancer Breast Cancer Head and Neck C... GI Cancer Cancer	Proactive Psych...	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for major depression and cancer