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

Cancer Caregivers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03856086
• Other study ID #: 18-539
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Caregivers

Intervention

Behavioral:
• Baseline questionnaire
Baseline questionnaire on the day of the patient's surgery.
• NCCN Problem List
NCCN Distress Thermometer
• FACT-GP
Greater overall quality of life
• HADS
Lower anxiety and depression
• CSS-CG
web-based CSS-CG

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Informal caregivers with unmet needs	comparing the 3-month change scores on the NCCN problem list from baseline	1 year

External Links

•   Memorial Sloan Kettering Cancer Center