Nurse AMIE: Addressing Metastatic Individuals Everyday

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Behavioral: Supportive Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention<br>The immediate intervention group will receive the intervention at the time of consent (baseline) and will be enrolled in the intervention for a total of 6 months. Patients will receive the tablet, a pedometer and an exercise band. Patients will use Nurse AMIE while receiving weekly phone calls from a patient navigator. After 90 days of the intervention observation will take place for 90 days, the patient will be asked to continue using Nurse AMIE without a patient navigator's presence. | Behavioral: Supportive Care<br>* Patient will receive the tablet, a pedometer (to track their steps) and an exercise band (to complete the exercise videos). Use of Nurse AMIE while receiving intervention phone calls from a patient navigator. After 90 days, observation begins and the patient will be asked to continue using Nurse AMIE without a patient navigator's presence.<br>|
| Experimental: Delayed Intervention<br>The delayed intervention group will receive the intervention 3 months after consent (6 months of intervention with 3 months delay total of 9 months); the patient will then follow the same pattern as listed above. The only difference is we will ask the delayed intervention group to wear a FitBit device for 1 week following consent in order to gain baseline data as to their activity/movement. | Behavioral: Supportive Care<br>* Patient will receive the tablet, a pedometer (to track their steps) and an exercise band (to complete the exercise videos). Use of Nurse AMIE while receiving intervention phone calls from a patient navigator. After 90 days, observation begins and the patient will be asked to continue using Nurse AMIE without a patient navigator's presence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the Application: The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist. | The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist. | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Feasibility, Acceptability, Supportive Care Platform