Identifying Family Members in Need of Support While Caregiving and After Loss

Advanced Cancer Clinical Trial

Official title:

Identifying Family Members in Need of Support While Caregiving and After Loss

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02455505
• Other study ID #: 15-095
• Status: Active, not recruiting
• Start date: May 2015
• Est. completion date: May 2027

Study information

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

Clinical Trial Summary

This screening tool will be used to identify significant relations of patients with advanced medical illness or serious hospitalization and family individuals who lost their loved one and who could use professional support in the future. We are interested in enrolling family members or close friends of patients with advanced medical illness as well as family members or close friends who have lost a loved one. Some screening tools to identify family members who might need support do exist, but the investigators are hoping to develop one that is brief and easier for healthcare providers to use. The information learned in this study will help us refine the screening tool. Family member input will be essential in the development of this screening tool.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• As per self-report, 21 years or older

• As per self-report, has a domestic partner or spouse, child (minor or adult), sibling (sister or brother), parent or close friend diagnosed with any advanced medical illness or who was recently (2 months) or is currently hospitalized for life-threatening injuries or conditions related to a traumatic incident (e.g., car accident, overdose, assault) OR

• As per self-report, experienced the recent (within 2 months to 3 years) death of a domestic partner or spouse, child (minor or adult), sibling, parent or close friend.

• Responds "yes" to the question "Can you understand spoken and written English?

• Agrees to be audio-taped during the cognitive interview [Waves 1 and 2 only] * For Part 2 only: In the event that the patient dies prior to a consenting pre-loss family member completing the study questionnaires, the family member will be eligible for participation in the post-loss group after at least 2 months have passed after the loss

Exclusion Criteria:

• Significant psychiatric or cognitive disturbance sufficient, in the investigators' judgment, to preclude the completion of the assessment measures or informed consent (i.e., acute psychiatric or neurological symptoms which require individual treatment)

• Another family member (parent, domestic partner or spouse, sibling, or adult child) has been enrolled in the study

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Behavioral:
• background questionnaire

• bereavement risk screening tool

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Calvary Hospital, Bronx, NY, The New School for Social Research, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to refine the bereavement risk screening tool and its items based on respondent feedback.	we will obtain family member input on the pre- and post-loss versions of the screening tool; we will obtain input from a separate sample of family members on a revised version of the screening tool that incorporates feedback	1 year

External Links

•   Memorial Sloan Kettering Cancer Center