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

Metastatic Breast Cancer Clinical Trial

— NurseAMIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456973
• Other study ID #: STUDY00006544
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: April 18, 2018

Study information

• Verified date: May 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 18, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Behavioral:
• Nurse AMIE
Supportive care software platform

Locations

Country	Name	City	State
United States	Penn State Cancer Institute	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Avon Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.
Other	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
Primary	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	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