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Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer (NurseAMIE)

Primary Purpose

Metastatic Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nurse AMIE
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women with metastatic breast cancer
  2. ECOG performance score ≤3.
  3. English Speaking
  4. With sufficient vision/hearing or family support

Exclusion Criteria:

  1. Medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction).
  2. Patients who are receiving any other behavioral intervention

Sites / Locations

  • Penn State Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nurse AMIE

Arm Description

Outcomes

Primary Outcome Measures

Feasibility- the proportion of patients who interact at least one month with tablet.
The proportion of women who consent, take a tablet home, who actually interact with the tablet and participate at least one month of the program.

Secondary Outcome Measures

Acceptability - the proportion of patients who agree to participate
The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.

Full Information

First Posted
June 6, 2017
Last Updated
May 1, 2019
Sponsor
Milton S. Hershey Medical Center
Collaborators
Avon Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03456973
Brief Title
Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer
Acronym
NurseAMIE
Official Title
Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
April 18, 2018 (Actual)
Study Completion Date
April 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Avon Foundation

4. Oversight

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

5. Study Description

Brief Summary
The investigators propose to build and test a supportive care software platform called Nurse AMIE (Addressing Metastatic Individuals Everyday) to be provided to metastatic breast cancer patients on Android Tablets. This program will be tested in 50 metastatic breast cancer patients within the Penn State Cancer Institute's 28 county catchment area. The company with whom the investigator will partner to develop this application is already working with multiple investigators at the institution (Webster Group).
Detailed Description
Goals of the Nurse AMIE software program are to regularly assess psychosocial, functional, and symptom needs among metastatic breast cancer patients and to provide appropriate interventions via YouTube style videos, weekly Skype calls (face to face, tablet to tablet) with a patient navigator at Penn State, and appropriate referrals to phone or in person consultations as needed. The proposed Nurse AMIE software program will allow for the provision of resources (YouTube style videos, audio files, exercises) to intervene on many of the common symptoms and challenges experienced by metastatic patients. This is an identified need on the part of both metastatic patients and their medical care teams. Finally, it will also allow patient navigators to check in with patients, reviewing responses to surveys, discerning whether new or different interventions are needed, and connecting women to palliative care and other services if additional care is warranted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nurse AMIE
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Nurse AMIE
Intervention Description
Supportive care software platform
Primary Outcome Measure Information:
Title
Feasibility- the proportion of patients who interact at least one month with tablet.
Description
The proportion of women who consent, take a tablet home, who actually interact with the tablet and participate at least one month of the program.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Acceptability - the proportion of patients who agree to participate
Description
The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Examine the effects of the program on quality of life
Description
This will be compared using surveys at the beginning and end of the study period (3 months)
Time Frame
3 months
Title
Qualitative assessment of physician, patient, and navigator endorsement of the program.
Description
At the conclusion of the study, physicians, patients and navigators will be asked semi-structured qualitative questions
Time Frame
1 month.
Title
Physical Function: Short Physical Performance Battery
Description
Objectively-measured physical function will be assessed using the Short Physical Performance Battery (SPPB). The SPPB is an accumulation of balance tests, 4-meter gait speed, and 5-chair stands. Based on the time needed to complete the chair stands, a score is given. A summation of scores from all tests is taken, ranging from 0 -12. A higher score = Higher physical function.
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with metastatic breast cancer ECOG performance score ≤3. English Speaking With sufficient vision/hearing or family support Exclusion Criteria: Medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction). Patients who are receiving any other behavioral intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn H Schmitz, PhD
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Cancer Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32022781
Citation
Oostra DL, Burse NR, Wolf LJ, Schleicher E, Mama SK, Bluethmann S, Schmitz K, Winkels RM. Understanding Nutritional Problems of Metastatic Breast Cancer Patients: Opportunities for Supportive Care Through eHealth. Cancer Nurs. 2021 Mar-Apr 01;44(2):154-162. doi: 10.1097/NCC.0000000000000788.
Results Reference
derived

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Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer

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