Identifying Family Members in Need of Support While Careg... | NCT02455505

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

NCT02455505

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Active, not recruiting

Last Update Posted

Jun 2, 2026Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Advanced Cancer

Interventions

background questionnaire
bereavement risk screening tool

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

May 2027Estimated

Completion Date

May 2027Estimated

First Submitted Date

May 22, 2015

First Submission Date that Met QC Criteria

May 26, 2015

First Posted Date

May 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2026

Last Update Posted Date

Jun 2, 2026Actual

Name	Class
Calvary Hospital, Bronx, NY	OTHER
The New School for Social Research	OTHER
Weill Medical College of Cornell University	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Label	Type	Description	Intervention Names
Risk Screening tool & Cognitive Interview			Behavioral: background questionnaire Behavioral: bereavement risk screening tool

Name	Type	Description	Arm Group Labels	Other Names
background questionnaire	Behavioral		Risk Screening tool & Cognitive Interview
bereavement risk screening tool

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan Kettering Cancer Center		New York	New York	10065	United States
Calvary Hospital