Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Depression

Breast Neoplasms

Lung Neoplasms

Depressive Disorder

Bipolar Disorder

Depressive Disorder, Major

Schizophrenia

Head and Neck Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Behavioral Symptoms

Mood Disorders

Mental Disorders

Psychotic Disorders

Schizophrenia Spectrum and Other Psychotic Disorders

Bipolar and Related Disorders

Gastrointestinal Diseases

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.

Proactive Psychiatry Consultation (PPC)

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

National Cancer Institute (NCI)

Massachusetts General Hospital

Principal Investigator

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.

Proactive Psychiatry Consultation (PPC) - Randomized Trial - CAREGIVERS

Total

Age, Continuous

Male

Female

Fluid / Non-Binary

Missing

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Caregiver Enrolled

Cancer diagnosis data collected for patients ONLY.

Cancer Diagnosis

Severe Mental Illness Diagnosis

Psychiatrist

Data point collected for caregivers ONLY.

Relationship to Patient

Baseline Characteristics data were collected from patients and caregivers

Kelly Irwin, MD, MPH

Disruptions in Cancer Care

Week 0

Week 12

Week 24

BPRS (24)

Week 6

PHQ-9

Enhanced Usual Care (EUC) - Randomized Trial: CAREGIVERS

Proactive Psychiatry Consultation (PPC) - Randomized Trial: CAREGIVERS

Overall Study

Anti-Infective Agents

All Drugs and Chemicals

Sulfamethazine

IMCP is based on the principles of Viktor Frankl's Logotherapy, and is designed to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose in their lives even as they approach the end of life. IMCP is structured as a 7-session (1-hour weekly sessions) individual intervention that utilizes a mixture of didactics, discussion and experiential exercises that focus around particular themes related to meaning and advanced cancer. In addition we will be asking patients in the IMCP arm to complete an optional weekly session rating survey

Individual Meaning-Centered Psychotherapy (IMCP)

The ISP intervention utilized as the comparison treatment condition in this study, is adapted from the Supportive Group Psychotherapy manualized intervention developed by David Payne (1997) and adapted by Drs. Kissane, Breitbart and colleagues into the ISP manualized intervention. This intervention is a 7-session individual supportive psychotherapy utilizing an approach to supportive psychotherapy based on models described by Rogers. The essential components of supportive psychotherapy are integrated into this manualized intervention, including: reassurance, explanation, guidance, suggestion, encouragement, affecting changes in patient's environment, and permission for catharsis.

standard Individual Supportive Psychotherapy (ISP)

We are therefore including what we refer to as an "enhanced" usual care arm to this randomized controlled trial to address the ethical issues raised by utilizing a usual care condition in a vulnerable advanced cancer population. Participants will receive feedback about their level of distress (based on the DT administered at screening) and given appropriate targeted referrals based on levels of distress and problem areas endorsed. Participants will be given a letter with a list of appropriate referrals.

enhanced usual care (EUC)

William Breitbart, MD

The aim of the study is to compare the benefits of three types of individual treatment programs for cancer patients: Meaning-Centered counseling, Supportive counseling, and Enhanced Usual Care.

We would like to train therapists in administering these types of counseling, so that they have expertise to work on the study. The therapists will administer either the Meaning-Centered counseling or the Supportive counseling, as part of their training.

Many cancer patients use counseling or other resources to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. "Meaning-Centered" counseling aims to teach cancer patients how to maintain or even increase a sense of meaning and purpose in their lives, despite cancer. "Supportive" counseling is intended to help the patient cope with cancer by giving them a place to express their feelings and get support. Enhanced Usual Care is intended to offer the patient referrals and resources that are matched to their individual needs in addition to the care they are already receiving at MSKCC.

Trial of Individual Psychosocial Interventions for Cancer Patients

A Randomized Controlled Trial of Individual Psychosocial Interventions for Cancer Patients

in improving meaning and spiritual well-being and overall quality of life and reducing psychological distress (depression and anxiety, hopelessness and desire for hastened death) in a sample of patients with advanced cancer.

(e.g., potential moderating influences such as gender, race/ethnicity, religiosity, level of pre-intervention social support, optimism, physical symptom burden, prognostic awareness, and treatment dose).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Trial of Individual Psychosocial Interventions for Cancer Patients	NCT01323309	Advanced Solid ...	Individual Mean... standard Indivi... enhanced usual ...	21 Years -	Memorial Sloan Kettering Cancer Center
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

Spots Global Cancer Trial Database for enhanced usual care (euc)