A Study of Mental Health Care in People With Cancer

Not Applicable

Recruiting

• Conditions: Colorectal Cancer; Lung Cancer; Breast Cancer; Prostate Cancer
• Interventions: Other: 30-minute telephone or videoconference sessions; Other: Questionnaires; Other: Interviews

• Registration Number: NCT06037954
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-07
• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Door for Cancer (OD-C)	30-minute telephone or videoconference sessions	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.
Usual Care	Questionnaires	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.
Usual Care	Interviews	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.

Primary Outcome Measures

Name	Time	Method
Refusal rates	2 years	≥75% of eligible patients enroll in the study
Attrition rates	2 years	≥80% of patients who enroll complete all study procedures

Secondary Outcome Measures

Name	Time	Method
Treatment satisfaction	2 years	Client Satisfaction Questionnaire-8 mean score of ≥3

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States