A Study of Mental Health Care in People With Cancer

Breast Cancer Clinical Trial

Official title:

Mental Health Care Initiation Intervention for Older Adults With Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037954
• Other study ID #: 23-218
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2023
• Est. completion date: September 2026

Study information

• Verified date: September 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Kelly McConnell, PhD
• Phone: 646-888-0026
• Email: mcconnek[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

Patients

• Per medical record, diagnosed with breast, colorectal, lung, or prostate cancer at age 65 years or older

• Per medical record, undergoing active cancer treatment (e.g., radiation, chemotherapy, immunotherapy, surgery) or within six months of completing treatment

• Score of =3 on the Patient Health Questionnaire-2 (PHQ-2)

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Lung Cancer
• Prostate Cancer

Intervention

Other:
• 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)
• Interviews
Interviews will be conducted by the qualitative methods specialist and trained study staff and will last 30-45 minutes.
• 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: Provide education about depression and treatment options Identify treatment preferences and a personal goal achievable with mental health care Assess barriers to treatment initiation Recommend a referral using standardized referral options Address barriers to accessing care

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refusal rates	=75% of eligible patients enroll in the study	2 years
Primary	Attrition rates	=80% of patients who enroll complete all study procedures	2 years
Secondary	Treatment satisfaction	Client Satisfaction Questionnaire-8 mean score of =3	2 years

External Links

•   Memorial Sloan Kettering Cancer Center