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Clinical Trials/NCT03456973
NCT03456973CompletedNot Applicable

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

Milton S. Hershey Medical Center2 sites in 1 country7 target enrollmentStarted: October 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
7
Locations
2
Primary Endpoint
Feasibility- the proportion of patients who interact at least one month with tablet.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Women with metastatic breast cancer
  • ECOG performance score ≤
  • 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

Arms & Interventions

Nurse AMIE

Experimental

Intervention: Nurse AMIE (Behavioral)

Outcomes

Primary Outcomes

Feasibility- the proportion of patients who interact at least one month with tablet.

Time Frame: 3 months

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 Outcomes

  • Acceptability - the proportion of patients who agree to participate(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kathryn Schmitz

Professor, Public Health Sciences

Milton S. Hershey Medical Center

Study Sites (2)

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