Clinical trial NCT02455505: Identifying Family Members in Need of Support While Caregiving and After Loss
Official title: Identifying Family Members in Need of Support While Caregiving and After Loss
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Advanced Cancer
Keywords: Cancer Care and Bereavement
Supportive Care
15-095
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Calvary Hospital, Bronx, NY
name: The New School for Social Research
name: Weill Medical College of Cornell University
First posted: 2015-05-28
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from MSK and Calvary Hospital locations (The Bronx, Brooklyn, and Manhattan), which provides hospice and bereavement services to patients suffering from advanced cancer and their families.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: to refine the bereavement risk screening tool and its items based on respondent feedback.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Calvary Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: William Rosa, PhD, MBE, MS
role: PRINCIPAL_INVESTIGATOR
References: