NCT06037954 · Memorial Sloan Kettering Cancer Center
A Study of Mental Health Care in People With Cancer
What this study is about
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.
View original scientific description
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.
Interventions
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)
OTHER
Interviews
Interviews will be conducted by the qualitative methods specialist and trained study staff and will last 30-45 minutes.
OTHER
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: 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
Primary outcome measures
Refusal rates
Time frame: 2 years
≥75% of eligible patients enroll in the study
Attrition rates
Time frame: 2 years
≥80% of patients who enroll complete all study procedures
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- New York, New York
Collaborators
Weill Medical College of Cornell University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations