Nurse AMIE for Echo Show: Randomized Control Trial

Penn State Health

Status: Completed

Conditions: Metastatic Breast Cancer

Treatments: Behavioral: Nurse AMIE (Addressing Metastatic Individuals Every day)

Study type: Interventional

Funder types: Other

Identifiers

NCT04673019

STUDY00016221

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female patient with metastatic breast cancer receiving care at PSCI
2. Age: ≥18years of age
3. Personal in-home Wi-Fi access
4. Personal device capable of receiving telephone calls for weekly study facilitator check-ins
5. Fluent in written and spoken English
6. Sufficient vision/hearing to use the Alexa Echo Show.

Exclusion criteria

1. ECOG Performance Status score of >2
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.
3. Receiving any behavioral intervention.
4. Pregnant
5. Cognitive impairment
6. Life expectancy of less than 6 months as determined by the treating physician

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Immediate Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Nurse AMIE (Addressing Metastatic Individuals Every day)

Delayed Intervention

Other group

Description:

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

Treatment:

Behavioral: Nurse AMIE (Addressing Metastatic Individuals Every day)