search
Back to results

A Study of Mental Health Care in People With Cancer

Primary Purpose

Breast Cancer, Colorectal Cancer, Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Questionnaires
Interviews
30-minute telephone or videoconference sessions
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring 65 years and older, Mental health care, 23-218

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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: 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

Sites / Locations

  • Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Open Door for Cancer (OD-C)

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Refusal rates
≥75% of eligible patients enroll in the study
Attrition rates
≥80% of patients who enroll complete all study procedures

Secondary Outcome Measures

Treatment satisfaction
Client Satisfaction Questionnaire-8 mean score of ≥3

Full Information

First Posted
September 8, 2023
Last Updated
September 8, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Weill Medical College of Cornell University
search

1. Study Identification

Unique Protocol Identification Number
NCT06037954
Brief Title
A Study of Mental Health Care in People With Cancer
Official Title
Mental Health Care Initiation Intervention for Older Adults With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer
Keywords
65 years and older, Mental health care, 23-218

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Door for Cancer (OD-C)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Interviews
Intervention Description
Interviews will be conducted by the qualitative methods specialist and trained study staff and will last 30-45 minutes.
Intervention Type
Other
Intervention Name(s)
30-minute telephone or videoconference sessions
Intervention Description
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 Outcome Measure Information:
Title
Refusal rates
Description
≥75% of eligible patients enroll in the study
Time Frame
2 years
Title
Attrition rates
Description
≥80% of patients who enroll complete all study procedures
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Treatment satisfaction
Description
Client Satisfaction Questionnaire-8 mean score of ≥3
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly McConnell, PhD
Phone
646-888-0026
Email
mcconnek@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Nelson, PhD
Phone
646-888-0030
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly McConnell, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly McDonnell, PhD
Phone
646-888-0026
First Name & Middle Initial & Last Name & Degree
Christian Nelson, PhD
Phone
646-888-0030

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

A Study of Mental Health Care in People With Cancer

We'll reach out to this number within 24 hrs