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Identifying Family Members in Need of Support During Cancer Care and Bereavement

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ClinicalTrials.gov Identifier: NCT02455505
Recruitment Status : Recruiting
First Posted : May 28, 2015
Last Update Posted : June 4, 2018
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

Brief Summary:
The purpose of this study is to develop a screening tool to help identify family members who may need professional emotional support. The investigators are interested in enrolling family members of patients with advanced cancer care as well as family members who have lost a loved one to cancer. 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. The investigators are interviewing family members to identify which questions or items work well, which seem unclear, and to understand how a family member might approach completing 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 Type : Observational
Estimated Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identifying Family Members in Need of Support During Cancer Care and Bereavement
Study Start Date : May 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bereavement

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



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



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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), or parent diagnosed with an advanced cancer diagnosis OR As per self-report, experienced the recent (within 2 months to 3 year) cancer-related death of a domestic partner or spouse, child (minor or adult), sibling, or parent
  • 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

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
Contact: Wendy Lichtenthal, PhD 646-888-4812
Contact: Stacy Stabler, MD 646-888-3194

Locations
United States, New York
Calvary Hospital Recruiting
Bronx, New York, United States, 10461
Contact: Sherry Schachter, PhD    718-518-2125      
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
Principal Investigator: Wendy Lichtenthal, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02455505     History of Changes
Other Study ID Numbers: 15-095
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
Cancer Care and Bereavement
Supportive Care
15-095