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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03456973
Acronym
NurseAMIE
Enrollment
7
Registered
2018-03-07
Start date
2017-10-01
Completion date
2018-04-18
Last updated
2019-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

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.

Interventions

BEHAVIORALNurse AMIE

Supportive care software platform

Sponsors

Avon Foundation
CollaboratorOTHER
Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility- the proportion of patients who interact at least one month with tablet.3 monthsThe 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

MeasureTime frameDescription
Acceptability - the proportion of patients who agree to participate3 monthsThe proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.

Other

MeasureTime frameDescription
Examine the effects of the program on quality of life3 monthsThis will be compared using surveys at the beginning and end of the study period (3 months)
Qualitative assessment of physician, patient, and navigator endorsement of the program.1 month.At the conclusion of the study, physicians, patients and navigators will be asked semi-structured qualitative questions
Physical Function: Short Physical Performance Battery9 monthsObjectively-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026