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

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

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

Conditions
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Cancer Caregivers

Intervention / Treatment
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* Behavioral: Baseline questionnaire
* Behavioral: NCCN Problem List
* Behavioral: FACT-GP
* Behavioral: HADS
* Behavioral: CSS-CG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized between screening with the CSS-CG + consultation (S+C, and enhanced usual care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enhanced usual care (EUC)<br>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<br>* Baseline questionnaire on the day of the patient's surgery.<br>Behavioral: NCCN Problem List<br>* NCCN Distress Thermometer<br>Behavioral: FACT-GP<br>* Greater overall quality of life<br>Behavioral: HADS<br>* Lower anxiety and depression<br>|
| Experimental: CancerSupportSource-CG screening plus consultation (S+C)<br>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<br>* Baseline questionnaire on the day of the patient's surgery.<br>Behavioral: NCCN Problem List<br>* NCCN Distress Thermometer<br>Behavioral: FACT-GP<br>* Greater overall quality of life<br>Behavioral: HADS<br>* Lower anxiety and depression<br>Behavioral: CSS-CG<br>* web-based CSS-CG<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comparing Distress Screening, Consultation With Enhanced Usual Care, Supportive care, 18-539