- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01805609
Training Model to Advance Support of the Family as a Caregiving System in the Inpatient Oncology Setting
March 1, 2024 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to provide a communication training program to inpatient nurses and social workers at Memorial Sloan Kettering Cancer Center in order to help them assist caregiving families.
The importance of this training program is that it aims to teach nurses and social workers how and when to respond more effectively and compassionately to challenges faced by caregiving families.
One of the goals of this program is to address family support needs during a patient's hospitalization.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Participating Providers:
- Provider is an MSKCC acute care advanced practice nurse and/or inpatient social worker as per self-report.
- Plans to attend at least 4/6 the didactic training sessions, and 3/6 consolidation sessions as per self-report.
A patient will be approached if:
- Patient has been admitted to an inpatient service at MSKCC.
- Patient is able to designate at least one close person who is involved in the patient's care and is willing to participate. In the case that the patient is a minor (age 7-17 yrs), s/he will need to designate at least one close, adult person who is involved in the patient's care and is willing to participate.
Family members will be approached if:
- They were identified as a close other (including a family friend) involved in the care of an admitted patient on a participating provider's floor
Exclusion Criteria:
- Evidence of cognitive impairment severe enough to preclude completing survey instruments as per clinical or research staff judgment or EMR.
- Determined to not be appropriate for this study as per clinical judgment. Anyone, patient or family member, who is younger than 12 years old.
- Anyone, patient or family member, who does not speak English.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Working with the Caregiving Family (WCF) training
This is a new training curriculum for inpatient oncology providers called Working with the Caregiving Family (WCF) training, a program designed to teach MSKCC inpatient staff to address family-level concerns during acute hospitalization.
The WCF training will teach staff to recognize and inquire about areas of family distress that are likely to impact the caregiving process; to provide brief, supportive interventions, and/or to transition families to specialized support services when needed.
We will provide staff with skills to address especially challenging family situations (e.g., noncompliance with medical care, conflict, poor communication) in collaborative and compassionate ways.
We will teach clinicians to intervene and respond more effectively when problematic relationships develop within families or between families and larger systems (e.g., medical team, institutional programs).
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Training curriculum will be comprised of 2 phases to be attended sequentially: (l) The Didactic Phase will consist of 6 twice a month seminars, administered over a 3 month period.
Each seminar includes a 1 hour lecture & discussion followed by 1 hour of role-play exercises; Lecture segments may include short training videos which Dr. Zaider uses in the nurses' training module she teaches through the Communication Skills Laboratory.
The teaching portion of the didactic sessions of the training may also be videotaped as a reference point for curriculum review.
Will explain to the providers that videotapes will only be available to study staff & that the role play portion will not be recorded; (2) Consolidation Phase will consist of 6 twice a month peer-group supervision meetings for ongoing consultation on family cases, also held across a 3 month period.
Length of these consolidations sessions will be up to 2 hours.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provider outcomes
Time Frame: 2 years
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which include observed changes in skills (Family Skills Adherence Scale) and subjective confidence level (Confidence in Family Skills Questionnaire) in conducting a family-centered psychosocial consultation with a caregiving family
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient and/or family members'outcomes
Time Frame: 2 years
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which include caregivers' satisfaction with aspects of psychosocial care (Satisfaction with Emotional Support Scale measure), perceived quality of communication about illness (Family Session Communication Measure) and perceived alliance with the participating nurse or social worker (Family Alliance Scale)
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Talia Zaider, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2013
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
February 28, 2013
First Submitted That Met QC Criteria
March 4, 2013
First Posted (Estimated)
March 6, 2013
Study Record Updates
Last Update Posted (Estimated)
March 4, 2024
Last Update Submitted That Met QC Criteria
March 1, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 13-030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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