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
1 other identifier
interventional
150
1 country
1
Brief Summary
This study will help the researchers find out whether the S+C approach is better, the same as, or worse than EUC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2019
CompletedStudy Start
First participant enrolled
February 25, 2019
CompletedFirst Posted
Study publicly available on registry
February 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2025
CompletedNovember 14, 2025
November 1, 2025
6.7 years
February 25, 2019
November 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Informal caregivers with unmet needs
comparing the 3-month change scores on the NCCN problem list from baseline
1 year
Study Arms (2)
Enhanced usual care (EUC)
ACTIVE COMPARATORICs 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,).
CancerSupportSource-CG screening plus consultation (S+C)
EXPERIMENTALICs 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).
Interventions
Baseline questionnaire on the day of the patient's surgery.
NCCN Distress Thermometer
Greater overall quality of life
Lower anxiety and depression
Eligibility Criteria
You may qualify if:
- 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."
- years old or older as per self report
- Agree to fulfill responsibilities as an IC during the perioperative phases as per self report
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- University of Virginiacollaborator
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allison Applebaum, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2019
First Posted
February 27, 2019
Study Start
February 25, 2019
Primary Completion
November 12, 2025
Study Completion
November 12, 2025
Last Updated
November 14, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF
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.