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

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ClinicalTrials.gov Identifier: NCT03856086
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
University of Virginia
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 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 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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




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



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Presenting to JRSC as the self-identified IC for a patient scheduled for any surgical procedure
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856086


Contacts
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Contact: Allison Applebaum, PhD 646-888-0034 applebaa@mskcc.org
Contact: William Breitbart, MD 646-888-0020

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Allison Applebaum, PhD    646-888-0034      
Contact: William Breitbart, MD    646-888-0020      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
University of Virginia
Investigators
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Principal Investigator: Allison Applebaum, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03856086     History of Changes
Other Study ID Numbers: 18-539
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
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)

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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