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Digital Cancer Care System for Mental Illness and Cancer

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks from study enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a digital cancer care system for people with serious mental illness and cancer, to improve care and manage psychiatric symptoms.

Who is the study for?

This trial is for adults over 18 with serious mental illness (like schizophrenia, bipolar disorder, or major depression) who also have a new diagnosis of stage I-IV breast, lung, gastrointestinal, genitourinary, or head and neck cancer. They must speak English fluently and be recently referred to MGH Danvers for oncology consultation.

What is being tested?

The study is testing the effectiveness of a virtual tumor board that addresses both cancer and mental health issues. It aims to see if this approach helps in patient care management, reduces psychiatric symptoms, and boosts clinician confidence in treating these patients.

What are the potential side effects?

Since this trial involves a non-medical intervention focusing on care coordination rather than direct treatment, traditional physical side effects are not expected. However, participants may experience changes in stress levels due to discussions about their conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks from study enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks from study enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks from study enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient enrollment assessed by consent rate.

Patient satisfaction assessed by patient feedback questionnaire.

Patient trial completion assessed by number of patients who complete study assessments and trial procedures.

Secondary study objectives

Number of participants contributing to multi-disciplinary representation at tumor board sessions.

Percentage of tumor board participants completing study questionnaires.

Percentage of tumor board participants participating in tumor board session.

+3 more

Other study objectives

Change in patient anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7).

Change in patient depression symptoms assessed by Patient Health Questionnaire-9 (PHQ-9).

Change in patient psychiatric illness severity assessed by Brief Psychiatric Rating Scale (BPRS).

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tumor Board ArmExperimental Treatment1 Intervention

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.

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