A Study of Mental Health Care in People With Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-07

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Open Door for Cancer (OD-C)

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.

Group Type EXPERIMENTAL

30-minute telephone or videoconference sessions

Intervention Type OTHER

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:

1. Provide education about depression and treatment options
2. Identify treatment preferences and a personal goal achievable with mental health care
3. Assess barriers to treatment initiation
4. Recommend a referral using standardized referral options
5. Address barriers to accessing care

Usual Care

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.

Group Type ACTIVE_COMPARATOR

Questionnaires

Intervention Type OTHER

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)

Interviews

Intervention Type OTHER

Interviews will be conducted by the qualitative methods specialist and trained study staff and will last 30-45 minutes.

Interventions

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Questionnaires

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)

Intervention Type OTHER

Interviews

Interviews will be conducted by the qualitative methods specialist and trained study staff and will last 30-45 minutes.

Intervention Type OTHER

30-minute telephone or videoconference sessions

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:

1. Provide education about depression and treatment options
2. Identify treatment preferences and a personal goal achievable with mental health care
3. Assess barriers to treatment initiation
4. Recommend a referral using standardized referral options
5. Address barriers to accessing care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients

* Per medical record and/or self-report, diagnosed with breast, colorectal, lung, or prostate cancer at age 65 years or older
* Per medical record and/or self-report, undergoing active cancer treatment (e.g., radiation, chemotherapy, immunotherapy, surgery) or within six months of completing treatment
* Score of ≥5 on the Patient Health Questionnaire-9 (PHQ-9)
* 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:

1. 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)
2. 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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No