NCT02455505

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
12mo left

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
May 2015May 2027

Study Start

First participant enrolled

May 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

12 years

First QC Date

May 22, 2015

Last Update Submit

May 28, 2025

Conditions

Keywords

Cancer Care and BereavementSupportive Care15-095

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Risk Screening tool & Cognitive Interview

Behavioral: background questionnaireBehavioral: bereavement risk screening tool

Interventions

Risk Screening tool & Cognitive Interview
Risk Screening tool & Cognitive Interview

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Calvary Hospital

The Bronx, New York, 10461, United States

Location

Related Links

Study Officials

  • William Rosa, PhD, MBE, MS

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2015

First Posted

May 28, 2015

Study Start

May 1, 2015

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations