Clinical trial NCT06037954: A Study of Mental Health Care in People With Cancer
Official title: Mental Health Care Initiation Intervention for Older Adults With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Lung Cancer
Prostate Cancer
Keywords: 65 years and older
Mental health care
23-218
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2023-09-14
Enrollment: 130
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Refusal rates
timeFrame: 2 years
measure: Attrition rates
timeFrame: 2 years
Secondary outcomes:
measure: Treatment satisfaction
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kelly McConnell, PhD
role: PRINCIPAL_INVESTIGATOR
References: