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Advancing Nursing Practices in Hospital Oncology Care

Primary Purpose

Gastrointestinal Cancer, Gastrointestinal Disease, Nurse's Role

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Partnership, Assessment, Care and Transition training intervention
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastrointestinal Cancer focused on measuring Family Caregiver, Family Centered Care, Inpatient Oncology Care, Nursing Practices, 20-448, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Nurses:

  • MSKCC day-shift nurses (Clinical Nurse I to IV) assigned to the GI inpatient unit (M16) at the time of study, all of whom provide initial and ongoing assessment of patients' physical, psychosocial, cultural and informational needs
  • Nurse is comfortable speaking and reading English as per self report

Family caregivers (FC) - Phases 1b, 2, 4:

  • Adult (≥18 yrs) family caregiver (family caregiver is defined here as any informal caregiver who is a relative, friend or legal representative) who self-identifies and/or is identified by the nursing staff as involved in the care of an MSK cancer patient who either:

    • is currently admitted to the M16 unity for at least 12 hours OR
    • has been discharged from the M16 unit within the last 2 weeks
  • English-speaking as per self-report
  • Only one FC per patient case will be invited to participate.

M16 Patients (chart review only):

  • Adult (≥18 yrs) cancer patient who is currently admitted in the M16 unit at Memorial Hospital for at least 12 hours o English speaking as per self-report

Exclusion Criteria:

Nurses:

  • Nurse plans to leave MSK or the GI unit within 3 months as per self-report
  • [Phases 2-4] Nurse refuses observation of consultations as per self-report

Family caregivers (FC) - Phases 1b, 2, 4:

  • FC participated in an earlier study phase
  • FC's patient is deceased at time of consent

Sites / Locations

  • Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nurses

Arm Description

MSKCC day-shift nurses (Clinical Nurse I to IV) assigned to the GI inpatient unit (MH16) at the time of study, all of whom provide initial and ongoing assessment of patients' physical, psychosocial, cultural and informational needs

Outcomes

Primary Outcome Measures

Frequency of nurses' use of family centered care practices
Frequency of nurses' use of family centered care practices as observed during inpatient consultations with family caregivers

Secondary Outcome Measures

Full Information

First Posted
September 14, 2021
Last Updated
October 23, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05053191
Brief Title
Advancing Nursing Practices in Hospital Oncology Care
Official Title
Advancing Family-Centered Care Nursing Practices in Inpatient Oncology Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2021 (Actual)
Primary Completion Date
September 3, 2024 (Anticipated)
Study Completion Date
September 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to find out if a new training program for nurses called PACT (Partnership, Assessment, Care, and Transition) will be effective and relevant in helping nurses gain the skills needed to provide high-quality family-centered care. Family-centered care skills include engaging family caregivers as partners in patient care, and strengthening their capacity for caregiving by assessing family support needs and facilitating access to resources when needed. The study will also look at whether the quality of nurses' family-centered care skills is associated with improved outcomes for family caregivers. Both nurses and family caregivers will be enrolled in this study. Participants will be nurses/caregivers who care for advanced GI cancer patients admitted to Memorial Sloan Kettering.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer, Gastrointestinal Disease, Nurse's Role
Keywords
Family Caregiver, Family Centered Care, Inpatient Oncology Care, Nursing Practices, 20-448, Memorial Sloan Kettering Cancer Center

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nurses
Arm Type
Experimental
Arm Description
MSKCC day-shift nurses (Clinical Nurse I to IV) assigned to the GI inpatient unit (MH16) at the time of study, all of whom provide initial and ongoing assessment of patients' physical, psychosocial, cultural and informational needs
Intervention Type
Behavioral
Intervention Name(s)
Partnership, Assessment, Care and Transition training intervention
Other Intervention Name(s)
PACT
Intervention Description
Partnership, Assessment, Care and Transition to psychosocial resources. Nurses who participate in PACT will receive 8 hours of training in a single, full-day workshop. We will train nurses in clusters of 10-12 nurses at one time, which will allow for cross-coverage with minimal disruption to workflow, and provide a more intimate, small-group learning environment.
Primary Outcome Measure Information:
Title
Frequency of nurses' use of family centered care practices
Description
Frequency of nurses' use of family centered care practices as observed during inpatient consultations with family caregivers
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Nurses: MSKCC day-shift nurses and/or night-shift nurses (Clinical Nurse I to IV) assigned to the GI inpatient unit (M16) at the time of study, all of whom provide initial and ongoing assessment of patients' physical, psychosocial, cultural and informational needs Nurse is comfortable speaking and reading English as per self report Family caregivers (FC) - Phases 1b, 2, 4: Adult (≥18 yrs) family caregiver (family caregiver is defined here as any informal caregiver who is a relative, friend or legal representative) who self-identifies and/or is identified by the nursing staff as involved in the care of an MSK cancer patient who either: is currently admitted to the M16 unity for at least 12 hours OR has been discharged from the M16 unit within the last 2 weeks English-speaking as per self-report Only one FC per patient case will be invited to participate. M16 Patients (chart review only): Adult (≥18 yrs) cancer patient who is currently admitted in the M16 unit at Memorial Hospital for at least 12 hours o English speaking as per self-report Exclusion Criteria: Nurses: Nurse plans to leave MSK or the GI unit within 3 months as per self-report [Phases 2-4] Nurse refuses observation of consultations as per self-report Family caregivers (FC) - Phases 1b, 2, 4: FC participated in an earlier study phase FC's patient is deceased at time of consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Talia Zaider, PhD
Phone
646-888-0031
Email
zaidert@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Talia Zaider, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Talia Zaider, PhD
Phone
646-888-0031

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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Advancing Nursing Practices in Hospital Oncology Care

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