Nurse AMIE: Addressing Metastatic Individuals Everyday

Not Applicable

Completed

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT03975621
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

Determine the acceptability and feasibility of a supportive care software platform to improve quality of life and function in metastatic breast cancer patients. Acceptability will be defined as the proportion of women offered the intervention who agree to participate. Feasibility will be defined as 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.

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 phone calls 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 Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-05
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

• Women with metastatic breast cancer
• ECOG performance score ≤3.
• English Speaking
• With sufficient vision/hearing or family support
• Willingness to be randomized

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of the Application: 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	Feasibility is defined as 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

Name	Time	Method
Acceptability of the Application: The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.	3 Months	The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.

Trial Locations

Locations (1)

Penn State Cancer Institute; 🇺🇸 Hershey, Pennsylvania, United States