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

• ClinicalTrials.gov Identifier: NCT03856086
• Recruitment Status: Active, not recruiting
• First Posted: February 27, 2019
• Last Update Posted: November 24, 2021
• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: University of Virginia
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cancer Caregivers	Behavioral: Baseline questionnaire; Behavioral: NCCN Problem List; Behavioral: FACT-GP; Behavioral: HADS; Behavioral: CSS-CG	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomized between screening with the CSS-CG + consultation (S+C, and enhanced usual care.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Impact of Caregiver Distress Screening, Targeted Referral and Consultation on MSK Caregiver, Patient and Health System Outcomes
• Actual Study Start Date: February 25, 2019
• Estimated Primary Completion Date: February 2023
• Estimated Study Completion Date: February 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number of Informal caregivers with unmet needs [ Time Frame: 1 year ]
   comparing the 3-month change scores on the NCCN problem list from baseline

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

University of Virginia

Investigators

• Principal Investigator: Allison Applebaum, PhD; Memorial Sloan Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center 

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT03856086
• Other Study ID Numbers: 18-539
• First Posted: February 27, 2019
• Last Update Posted: November 24, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

• 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:

Comparing Distress Screening; Consultation With Enhanced Usual Care; Supportive care; 18-539