A Study of Mental Health Care in People With Cancer

NCT06037954 | Recruiting

• 1 other identifier: 23-218
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Colorectal Cancer; Lung Cancer; Prostate Cancer

Keywords

65 years and older; Mental health care; 23-218

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Treatment satisfaction

  2 years

Study Arms (2)

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

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; Other: Interviews

Interventions

Questionnaires 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)

Usual Care

Interviews OTHER

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

Usual Care

30-minute telephone or videoconference sessions 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

Open Door for Cancer (OD-C)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Prostatic Neoplasms

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kelly McConnell, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly McConnell, PhD

CONTACT

646-888-0026; mcconnek@mskcc.org

Christian Nelson, PhD

CONTACT

646-888-0030

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 14, 2023
• Study Start: September 7, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)