Clinical trial NCT04673019: Nurse AMIE for Echo Show: Randomized Control Trial
Official title: Nurse AMIE for Echo Show: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Breast Cancer
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Penn State University
name: American Institute for Cancer Research
First posted: 2020-12-17
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - the proportion of patients who interact with the tablet for at least one month
timeFrame: 90 days
measure: Acceptability - the proportion of patients who agree to participate
timeFrame: baseline
Secondary outcomes:
measure: Physical Function: Short Physical Performance Battery (SPPB)
timeFrame: baseline
measure: Physical Function: Short Physical Performance Battery (SPPB)
timeFrame: month 3
measure: Physical Function: Short Physical Performance Battery (SPPB)
timeFrame: month 6
measure: Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)
timeFrame: baseline
measure: Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)
timeFrame: month 3
measure: Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)
timeFrame: month 6
measure: Sleep Quality and Sleep Problems
timeFrame: baseline
measure: Sleep Quality and Sleep Problems
timeFrame: month 3
measure: Sleep Quality and Sleep Problems
timeFrame: month 6
measure: Well-being measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B+4)
timeFrame: baseline
measure: Well-being measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B+4)
timeFrame: month 3
measure: Well-being measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B+4)
timeFrame: month 6
measure: Distress measured using the Penn State Cancer Institute Distress Inventory
timeFrame: baseline
measure: Distress measured using the Penn State Cancer Institute Distress Inventory
timeFrame: month 3
measure: Distress measured using the Penn State Cancer Institute Distress Inventory
timeFrame: month 6
measure: Pain Severity and Pain Interference measured by the Brief Pain Inventory (BPI)
timeFrame: baseline
measure: Pain Severity and Pain Interference measured by the Brief Pain Inventory (BPI)
timeFrame: month 3
measure: Pain Severity and Pain Interference measured by the Brief Pain Inventory (BPI)
timeFrame: month 6
measure: Fatigue measured using the Brief Fatigue Inventory (BFI)
timeFrame: baseline
measure: Fatigue measured using the Brief Fatigue Inventory (BFI)
timeFrame: month 3
measure: Fatigue measured using the Brief Fatigue Inventory (BFI)
timeFrame: month 6
Other outcomes:
measure: Physical Activity
timeFrame: Daily for 90 days
measure: Usability as measured by the System Usability Scale (SUS)
timeFrame: month 3
measure: Usability as measured by the System Usability Scale (SUS)
timeFrame: month 6
measure: App Quality measured by the Mobile Application Rating Scale (U-MARS)
timeFrame: month 3
measure: App Quality measured by the Mobile Application Rating Scale (U-MARS)
timeFrame: month 6
measure: Comprehensive Symptom Assessment measured with the Patient-Generated Subjective Global Assessment (PG-SGA)
timeFrame: Weekly over a 3 month (90 day) intervention period
Locations:
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State Milton Hershey Medical Center
name: Kathryn H Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: