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

Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)

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).

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Behavioral: Nurse AMIE

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nurse AMIE	Behavioral: Nurse AMIE; Supportive care software platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examine the effects of the program on quality of life	This will be compared using surveys at the beginning and end of the study period (3 months)	3 months
Qualitative assessment of physician, patient, and navigator endorsement of the program.	At the conclusion of the study, physicians, patients and navigators will be asked semi-structured qualitative questions	1 month.
Physical Function: Short Physical Performance Battery	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.	9 months

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Avon Foundation
• Investigators: Principal Investigator: Kathryn H Schmitz, PhD, Penn State College of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2017
• Primary Completion (ACTUAL): April 18, 2018
• Study Completion (ACTUAL): April 18, 2018

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (ACTUAL): March 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: STUDY00006544

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No