Nurse AMIE for Echo Show: Randomized Control Trial

Study Overview
=================
Brief Summary
-----------------
The Nurse AMIE platform has been modified for use as an Amazon Alexa skill for use on the Echo Show device. The investigators will recruit women receiving treatment for metastatic breast cancer and randomize patients to receive standard treatment (control) or the Nurse AMIE for Echo Show program. Nurse AMIE is a supportive care program for women undergoing chemotherapy and helps manage symptoms. The investigators will test the feasibility of using the Nurse AMIE program as well as its effectiveness at managing symptoms.

Detailed Description
-----------------
The investigators will recruit 42 MBC patients and randomize them into a partial crossover trial in which immediate treatment group participants receive the Nurse AMIE intervention in full for 3 months, then continue Nurse AMIE (without navigation) for 3 months, while the delayed intervention group will not receive an intervention for 3 months, followed by receiving the Nurse AMIE full intervention with navigation for 3 months. The primary comparisons will be between the immediate treatment and delayed treatment groups over the first 3 months. Intervention. Participants will all receive an Amazon Echo Show device, WiFi connection (if patients do not already have one), pedometer, and resistance bands. Each day, the participant will open the Nurse AMIE for Echo Show, which will result in the daily greeting. After the greeting, participants will be asked to provide a verbal rating of their symptoms (e.g., pain, sleep, fatigue, and distress). After completing the symptom survey, Nurse AMIE will use an algorithm to discern which of the intervention modules to offer as assistance for the reported symptoms. These interventions include exercise, guided relaxation, cognitive behavioral therapy, and soothing music. These guideline-based interventions are provided as audio files or YouTube-style videos. In addition, Nurse AMIE provides a daily educational nutrition tip as well as recipes designed to be of interest to people undergoing chemotherapy. Each week, the participant will receive a phone call from the study navigator. This navigator will monitor symptom ratings daily and will discuss symptoms, interventions, and step goals with the participant each week.

Official Title
-----------------
Nurse AMIE for Echo Show: Randomized Control Trial

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Nurse AMIE (Addressing Metastatic Individuals Every day)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patient with metastatic breast cancer receiving care at PSCI Age: ≥18years of age Personal in-home Wi-Fi access Personal device capable of receiving telephone calls for weekly study facilitator check-ins Fluent in written and spoken English Sufficient vision/hearing to use the Alexa Echo Show. Exclusion Criteria: ECOG Performance Status score of >2 Patients with significant medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that in the opinion of the research team exclude the subject from participation. Receiving any behavioral intervention. Pregnant Cognitive impairment Life expectancy of less than 6 months as determined by the treating physician

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a partial crossover trial in which immediate treatment group participants receive the Nurse AMIE intervention in full for 3 months, then continue Nurse AMIE (without navigation) for 3 months, while the delayed intervention group will not receive an intervention for 3 months, followed by receiving the Nurse AMIE full intervention with navigation for 3 months. The primary comparisons will be between the immediate treatment and delayed treatment groups over the first 3 months.
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: Months 1- 3 (Approximately Day 1-Day 90) Participant will receive the Echo Show, a pedometer (to track their steps) and an exercise band (to complete the exercise interventions). Use of Nurse AMIE while receiving intervention phone calls from a study facilitator. We are interested in learning whether the phone calls are necessary or if the Nurse AMIE platform can stand alone and see the same effect. Months 4-6 (Approximately Day 91-180) o Participant will continue to use Nurse AMIE, but without phone calls from study facilitator | Behavioral: Nurse AMIE (Addressing Metastatic Individuals Every day)<br>* Supportive Care Platform (behavioral interventions that are offered based on answers to daily symptom rating questions). Interventions offered include walking, balance, strength exercise, guided relaxation, CBT, DBT, soothing music.<br>|
| Other: Delayed Intervention<br>The delayed intervention group will receive the intervention 3 months after consent (3 months of no intervention followed by with 3 months of intervention, for a total of 6 months); the participant will follow the pattern listed below: Months 1- 3 Approximately (Day 1-Day 90) o No use of Nurse AMIE Months 4-6 (Approximately Day 91-180) Participant will receive the Echo Show, a pedometer (to track their steps) and an exercise band (to complete the exercise interventions). Use of Nurse AMIE while receiving intervention phone calls from a study facilitator | Behavioral: Nurse AMIE (Addressing Metastatic Individuals Every day)<br>* Supportive Care Platform (behavioral interventions that are offered based on answers to daily symptom rating questions). Interventions offered include walking, balance, strength exercise, guided relaxation, CBT, DBT, soothing music.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - the proportion of patients who interact with the tablet for at least one month | The proportion of women who consent, take a tablet home, who actually interact with the Nurse AMIE platform at least 30 out of 90 possible days | 90 days | 
| Acceptability - the proportion of patients who agree to participate | The proportion of women who agree to participate among those deemed eligible and cleared by oncologist. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Function: 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. | baseline | 
| Physical Function: 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. | month 3 | 
| Physical Function: 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. | month 6 | 
| Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36) | The SF-36 measures quality of life in the following domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well being, social functioning, pain, and general health. All items are scored from 0 to 100, with 100 being the highest level of functioning possible. Items are averaged to give ratings on each of 8 dimensions. | baseline | 
| Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36) | The SF-36 measures quality of life in the following domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well being, social functioning, pain, and general health. All items are scored from 0 to 100, with 100 being the highest level of functioning possible. Items are averaged to give ratings on each of 8 dimensions. | month 3 | 
| Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36) | The SF-36 measures quality of life in the following domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well being, social functioning, pain, and general health. All items are scored from 0 to 100, with 100 being the highest level of functioning possible. Items are averaged to give ratings on each of 8 dimensions. | month 6 | 
| Sleep Quality and Sleep Problems | measured using the Pittsburgh Sleep Quality Inventory. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. | baseline | 
| Sleep Quality and Sleep Problems | measured using the Pittsburgh Sleep Quality Inventory. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. | month 3 | 
| Sleep Quality and Sleep Problems | measured using the Pittsburgh Sleep Quality Inventory. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. | month 6 | 
| Well-being measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B+4) | This measure is specific to patients with breast cancer and measures well-being in several domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The items are rated from 0 to 4, and total scores for each domain are the sums of the items (0 being low well-being). The total FACT-B score is the sum of the domains, with scores ranging from 0 to 148, with 148 being the highest level of well-being possible. | baseline | 
| Well-being measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B+4) | This measure is specific to patients with breast cancer and measures well-being in several domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The items are rated from 0 to 4, and total scores for each domain are the sums of the items (0 being low well-being). The total FACT-B score is the sum of the domains, with scores ranging from 0 to 148, with 148 being the highest level of well-being possible. | month 3 | 
| Well-being measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B+4) | This measure is specific to patients with breast cancer and measures well-being in several domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The items are rated from 0 to 4, and total scores for each domain are the sums of the items (0 being low well-being). The total FACT-B score is the sum of the domains, with scores ranging from 0 to 148, with 148 being the highest level of well-being possible. | month 6 | 
| Distress measured using the Penn State Cancer Institute Distress Inventory | The PSCI Distress Inventory is a 5-item questionnaire, which measures distress associated with: practical problems, family problems, emotional problems, spiritual religious concerns, and physical problems. The responses are rated from 0 (no distress) to 10 (severe distress). | baseline | 
| Distress measured using the Penn State Cancer Institute Distress Inventory | The PSCI Distress Inventory is a 5-item questionnaire, which measures distress associated with: practical problems, family problems, emotional problems, spiritual religious concerns, and physical problems. The responses are rated from 0 (no distress) to 10 (severe distress). | month 3 | 
| Distress measured using the Penn State Cancer Institute Distress Inventory | The PSCI Distress Inventory is a 5-item questionnaire, which measures distress associated with: practical problems, family problems, emotional problems, spiritual religious concerns, and physical problems. The responses are rated from 0 (no distress) to 10 (severe distress). | month 6 | 
| Pain Severity and Pain Interference measured by the Brief Pain Inventory (BPI) | The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. | baseline | 
| Pain Severity and Pain Interference measured by the Brief Pain Inventory (BPI) | The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. | month 3 | 
| Pain Severity and Pain Interference measured by the Brief Pain Inventory (BPI) | The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. | month 6 | 
| Fatigue measured using the Brief Fatigue Inventory (BFI) | The BFI is a nine-item measure, with scores ranging from 0 being best/no fatigue, and 10 being fatigue as bad as imaginable. A global fatigue score is calculated as an average of the nine items. | baseline | 
| Fatigue measured using the Brief Fatigue Inventory (BFI) | The BFI is a nine-item measure, with scores ranging from 0 being best/no fatigue, and 10 being fatigue as bad as imaginable. A global fatigue score is calculated as an average of the nine items. | month 3 | 
| Fatigue measured using the Brief Fatigue Inventory (BFI) | The BFI is a nine-item measure, with scores ranging from 0 being best/no fatigue, and 10 being fatigue as bad as imaginable. A global fatigue score is calculated as an average of the nine items. | month 6 |