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NCT Number: NCT06037954

A Study of Mental Health Care in People With Cancer

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.

Recruiting

Interested in participating?

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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

Treatment and study plan

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)

Interviews

Other

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

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:

  • 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

Primary outcomes

  1. Refusal rates

    Time frame: 2 years

    ≥75% of eligible patients enroll in the study

  2. Attrition rates

    Time frame: 2 years

    ≥80% of patients who enroll complete all study procedures

Secondary outcomes

  1. Treatment satisfaction

    Time frame: 2 years

    Client Satisfaction Questionnaire-8 mean score of ≥3

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Nelson, PhD

CONTACT

646-888-0030

Kelly McConnell, PhD

CONTACT

[email protected]

646-888-0026

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Weill Medical College of Cornell University

Registry information

Official study title

Mental Health Care Initiation Intervention for Older Adults With Cancer

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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