A Study of Mental Health Care in People with Cancer

Clinicaltrials.gov ID: NCT06037954
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 65 Years
b-bullseye-arrow Enrollments 130

Conditions

Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Kelly McDonnell, PhD
  • 646-888-0026

Principal Investigator

  • Kelly McConnell, PhD

Eligibility Criteria

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

Study Plan

Open Door for Cancer (OD-C)

EXPERIMENTAL

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

    Description:

    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:nn1. Provide education about depression and treatment optionsn2. Identify treatment preferences and a personal goal achievable with mental health caren3. Assess barriers to treatment initiationn4. Recommend a referral using standardized referral optionsn5. Address barriers to accessing care

Usual Care

ACTIVE_COMPARATOR

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

    Description:

    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)
  • OTHER:

    Interviews

    Description:

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

Outcome Measures

Primary Outcome Measures

Refusal rates

Time Frame: 2 years

Attrition rates

Time Frame: 2 years

Secondary Outcome Measures

Treatment satisfaction

Time Frame: 2 years

Timeline

  • Last Updated
    October 23, 2024
  • Start Date
    September 14, 2023
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    September 1, 2026

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