A Study of Mental Health Care in People With Cancer

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT06037954
Collaborator
Weill Medical College of Cornell University (Other)
130
1
2
35.8
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaires
  • Other: Interviews
  • Other: 30-minute telephone or videoconference sessions
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This protocol aims to refine and pilot test a brief telehealth intervention, Open Door for Cancer (OD-C), that addresses individual barriers to mental health service initiation in depressed older adults with cancer (OACs) without requiring in-person appointments.This protocol aims to refine and pilot test a brief telehealth intervention, Open Door for Cancer (OD-C), that addresses individual barriers to mental health service initiation in depressed older adults with cancer (OACs) without requiring in-person appointments.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Mental Health Care Initiation Intervention for Older Adults With Cancer
Actual Study Start Date :
Sep 7, 2023
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

Arm Intervention/Treatment
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.

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: 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

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Refusal rates [2 years]

    ≥75% of eligible patients enroll in the study

  2. Attrition rates [2 years]

    ≥80% of patients who enroll complete all study procedures

Secondary Outcome Measures

  1. Treatment satisfaction [2 years]

    Client Satisfaction Questionnaire-8 mean score of ≥3

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center
  • Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Kelly McConnell, PhD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT06037954
Other Study ID Numbers:
  • 23-218
First Posted:
Sep 14, 2023
Last Update Posted:
Sep 14, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2023