A Study of Mental Health Care in People With Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at mental health services for adults with depressed mood who were diagnosed with cancer at the age of 65 or older. This study will compare the usual approach for connecting older adults with depressed mood to mental health services with the Open Door for Cancer (OD-C) approach. We will find out if the OD-C approach is practical and useful for cancer patients who participate in the intervention and for providers who see or treat cancer patients.

Official Title
-----------------
Mental Health Care Initiation Intervention for Older Adults With Cancer

Conditions
-----------------
Prostate Cancer, Breast Cancer, Colorectal Cancer, Lung Cancer

Intervention / Treatment
-----------------
* Other: Questionnaires
* Other: Interviews
* Other: 30-minute telephone or videoconference sessions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Per medical record, diagnosed with breast, colorectal, lung, or prostate cancer at age 65 years or older Per medical record, undergoing active cancer treatment (e.g., radiation, chemotherapy, immunotherapy, surgery) or within six months of completing treatment Score of ≥3 on the Patient Health Questionnaire-2 (PHQ-2) Per self-report, fluent in English** ** Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify English fluency necessary for participation in the study: How well do you speak English? (must respond very well or well when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused) What is your preferred language for healthcare? (must respond English) Providers Per self-report, works in oncology, nursing, social work, psychology, or psychiatry Per self-report, currently works in oncology at least 50% of the time Per self-report, provided cancer care for at least three years at time of consent Per self-report, fluent in English Exclusion Criteria: Patients Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration scores of ≥ 11 Per research staff judgment and/or self-report, too ill or weak to complete study procedures Per medical record and/or self-report, receiving hospice care at the time of enrollment Per medical record and/or self-report, currently enrolled in mental health treatment Providers N/A

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This protocol aims to refine and pilot test a brief telehealth intervention, Open Door for Cancer (OD-C), that addresses individual barriers to mental health service initiation in depressed older adults with cancer (OACs) without requiring in-person appointments.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Door for Cancer (OD-C)<br>OD-C includes five components delivered in three 30-minute telephone or videoconference visits over six weeks and one booster telephone call. All sessions are audio-recorded. | Other: 30-minute telephone or videoconference sessions<br>* Includes five components delivered in three 30-minute telephone or videoconference visits over six weeks and one booster telephone call. All sessions are audio-recorded. The five components are: Provide education about depression and treatment options Identify treatment preferences and a personal goal achievable with mental health care Assess barriers to treatment initiation Recommend a referral using standardized referral options Address barriers to accessing care<br>|
| Active Comparator: Usual Care<br>Participants assigned to Usual Care (n=50) will receive standard care. MSK's current usual care for distress screening is that all patients are screened for distress when they initiate care at MSK. Additional distress screening is conducted based on the determination of the oncology team. In addition, patients are referred to social work, psychology, and/or psychiatry based on the judgment of the oncology team. | Other: Questionnaires<br>* Patient demographic characteristics, Clinical variables, Cornell Service Index-Short Form (CSI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder scale-7 (GAD-7), Client Satisfaction Questionnaire (CSQ-8), Intention to Seek Help Scale, Health Beliefs about Mental Illness Instrument (HBMII) - Emotional/Nervous Severity Scale, Health Beliefs about Mental Illness Instrument (HBMII) - Emotional/Nervous Benefits Scale, Barriers to Mental Health Services Scale-Revised, Cues to action, Self-Efficacy to Seek Mental Health Care (SE-SMHC)<br>Other: Interviews<br>* Interviews will be conducted by the qualitative methods specialist and trained study staff and will last 30-45 minutes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refusal rates | ≥75% of eligible patients enroll in the study | 2 years | 
| Attrition rates | ≥80% of patients who enroll complete all study procedures | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment satisfaction | Client Satisfaction Questionnaire-8 mean score of ≥3 | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
65 years and older, Mental health care, 23-218