Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02455505
Recruitment Status : Recruiting
First Posted : May 28, 2015
Last Update Posted : May 12, 2020
Sponsor:
Collaborators:
Calvary Hospital, Bronx, NY
The New School for Social Research
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Advanced Cancer Behavioral: background questionnaire Behavioral: bereavement risk screening tool

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identifying Family Members in Need of Support While Caregiving and After Loss
Study Start Date : May 2015
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bereavement

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Risk Screening tool & Cognitive Interview Behavioral: background questionnaire
Behavioral: bereavement risk screening tool


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. to refine the bereavement risk screening tool and its items based on respondent feedback. [ Time Frame: 1 year ]
    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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455505


Contacts
Layout table for location contacts
Contact: Wendy Lichtenthal, PhD 646-888-4812
Contact: Stacy Stabler, MD 646-888-3194

Locations
Layout table for location information
United States, New York
Calvary Hospital Active, not recruiting
Bronx, New York, United States, 10461
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Wendy Lichtenthal, Ph.D.    646-888-4812      
Principal Investigator: Wendy Lichtenthal, Ph.D.         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Calvary Hospital, Bronx, NY
The New School for Social Research
Weill Medical College of Cornell University
Investigators
Layout table for investigator information
Principal Investigator: Wendy Lichtenthal, PhD Memorial Sloan Kettering Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02455505    
Other Study ID Numbers: 15-095
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
Cancer Care and Bereavement
Supportive Care
15-095