Comparing Distress Screening + Consultation With Enhanced Usual Care for Caregivers of Cancer Patients

The Impact of Caregiver Distress Screening, Targeted Referral and Consultation on MSK Caregiver, Patient and Health System Outcomes

This study will help the researchers find out whether the S+C approach is better, the same as, or worse than EUC.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer Caregivers
• Intervention / Treatment: Behavioral: Baseline questionnaire; Behavioral: NCCN Problem List; Behavioral: FACT-GP; Behavioral: HADS; Behavioral: CSS-CG

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Self-identified caregiver to a patient receiving surgery at JRSC OR self-identified caregiver to a patient at various inpatient surgical floors (i.e., M4, M7, M8) at the Main Hospital OR self-identified caregiver to a patient at the BMT clinic.
• English fluency: Self-report by subject identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well."
• 18 years old or older as per self report
• Agree to fulfill responsibilities as an IC during the perioperative phases as per self report

Exclusion Criteria:

• Cognitive difficulties that preclude participation in the intervention or accurate assessment in the judgment of the PI
• Medical illness that is of sufficient severity to preclude further participation in the study.
• Presenting to JRSC as the IC for a patient undergoing a prophylactic procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enhanced usual care (EUC); ICs randomized to EUC following baseline questionnaire completion will be given instructions (Appendix I) on how to access or create an account to access the myMSK online portal IC Resources page (https://my.mskcc.org/login). If the caregiver does not wish to enroll in MyMSK, the research study staff will send them an email with sample referral material ( Appendix D. The IC Resources page includes links to extant MSK educational materials for ICs (e.g., "A Guide for Caregivers" [47]), contact information for psychosocial services (e.g., Caregivers Clinic in the MSK Counseling Center), and external resources (e.g., educational materials and services through the CSC, American Cancer Society, and others) (Appendix D,).	Behavioral: Baseline questionnaire; Baseline questionnaire on the day of the patient's surgery.; Behavioral: NCCN Problem List; NCCN Distress Thermometer; Behavioral: FACT-GP; Greater overall quality of life; Behavioral: HADS; Lower anxiety and depression
Experimental: CancerSupportSource-CG screening plus consultation (S+C); ICs randomized to S+C will complete the web-based CSS-CG (Appendix C) using a tablet immediately following baseline study measures. In case of technical issues, ICs may complete Appendix C with the guidance of a member of the research study team. The CSS-CG asks ICs to rate their level of concern for 33 different possible problems: if a need is rated as low (i.e., "A little" or less concern), after each problem is rated ICs will be prompted to request pertinent educational materials if they are interested. If a need is endorsed (i.e., "Moderate" or greater concern), ICs are asked through the web-based electronic platform (https://mskcc.mycarereport.com) whether they would like educational materials and/or to speak with someone about that need (i.e., receive a referral).	Behavioral: Baseline questionnaire; Baseline questionnaire on the day of the patient's surgery.; Behavioral: NCCN Problem List; NCCN Distress Thermometer; Behavioral: FACT-GP; Greater overall quality of life; Behavioral: HADS; Lower anxiety and depression; Behavioral: CSS-CG; web-based CSS-CG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Informal caregivers with unmet needs	comparing the 3-month change scores on the NCCN problem list from baseline	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: University of Virginia
• Investigators: Principal Investigator: Allison Applebaum, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Supportive care; Comparing Distress Screening; Consultation With Enhanced Usual Care; 18-539
• Other Study ID Numbers: 18-539

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No