Recruiting

Mental Health Care

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06037954

Conditions

Breast Cancer

Colorectal Cancer

Lung Cancer

Prostate Cancer

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Questionnaires

Interviews

30-minute telephone or videoconference sessions

Study Details

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

Study ID

NCT06037954

Start date

Sep 7, 2023

Status verified date

Jul, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Open Door for Cancer (OD-C)

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.

active comparator: Usual Care

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.

Interventions

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:

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 measure

  • Refusal rates [ Time Frame: 2 years ]
  • Attrition rates [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Kelly McConnell, PhD

646-888-0026mcconnek@mskcc.org

Christian Nelson, PhD

646-888-0030

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Kelly McDonnell, PhD

646-888-0026

Christian Nelson, PhD

646-888-0030

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-13.