Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer
NurseAMIE
1 other identifier
interventional
7
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedFirst Posted
Study publicly available on registry
March 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2018
CompletedMay 3, 2019
May 1, 2019
7 months
June 6, 2017
May 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Acceptability - the proportion of patients who agree to participate
3 months
Other Outcomes (3)
Examine the effects of the program on quality of life
3 months
Qualitative assessment of physician, patient, and navigator endorsement of the program.
1 month.
Physical Function: Short Physical Performance Battery
9 months
Study Arms (1)
Nurse AMIE
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Women with metastatic breast cancer
- ECOG performance score ≤3.
- English Speaking
- With sufficient vision/hearing or family support
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Milton S. Hershey Medical Centerlead
- Avon Foundationcollaborator
Study Sites (1)
Penn State Cancer Institute
Hershey, Pennsylvania, 17033, United States
Related Publications (1)
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.
PMID: 32022781DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn H Schmitz, PhD
Penn State College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Public Health Sciences
Study Record Dates
First Submitted
June 6, 2017
First Posted
March 7, 2018
Study Start
October 1, 2017
Primary Completion
April 18, 2018
Study Completion
April 18, 2018
Last Updated
May 3, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share