Nurse AMIE for Echo Show: Randomized Control Trial

Metastatic Breast Cancer Clinical Trial

Official title:

Nurse AMIE for Echo Show: Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673019
• Other study ID #: STUDY00016221
• Status: Completed
• Phase: N/A
• Start date: February 2, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Breast Cancer

Intervention

Behavioral:
• Nurse AMIE (Addressing Metastatic Individuals Every day)
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.

Locations

Country	Name	City	State
United States	Hershey Medical Center	Hershey	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	American Institute for Cancer Research, Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical Activity	measured using step counts recorded with an analog pedometer, self-reported to the Nurse AMIE platform by the participant each day	Daily for 90 days
Other	Usability as measured by the System Usability Scale (SUS)	Ease of use of the Nurse AMIE for Echo Show platform will be assessed using the System Usability Scale (SUS). Each of the 10 items on this scale are rated from 0 to 4. Items are summed and multiplied by 2.5 to obtain the overall value of the usability. SUS scores range from 0 to 100, with the higher score indicating better ease of use.	month 3
Other	Usability as measured by the System Usability Scale (SUS)	Ease of use of the Nurse AMIE for Echo Show platform will be assessed using the System Usability Scale (SUS). Each of the 10 items on this scale are rated from 0 to 4. Items are summed and multiplied by 2.5 to obtain the overall value of the usability. SUS scores range from 0 to 100, with the higher score indicating better ease of use.	month 6
Other	App Quality measured by the Mobile Application Rating Scale (U-MARS)	Ease of use of the Nurse AMIE for Echo Show platform measured by the Mobile Application Rating Scale (U-MARS). Each item is rated from 1 (inadequate) to 5 (excellent). Items are summed to give subscores of Engagement, Functionality, Aesthetics, Information. These subscores can be averaged to give an app quality score. Further, there are two additional scores, the subjective quality and app-specific scores that are used to assess the participant's view of the quality of the app and the impact of the app on knowledge, attitudes, intentions, and change in target health behavior, respectively. The higher the score, the more favorable the app quality is.	month 3
Other	App Quality measured by the Mobile Application Rating Scale (U-MARS)	Ease of use of the Nurse AMIE for Echo Show platform measured by the Mobile Application Rating Scale (U-MARS). Each item is rated from 1 (inadequate) to 5 (excellent). Items are summed to give subscores of Engagement, Functionality, Aesthetics, Information. These subscores can be averaged to give an app quality score. Further, there are two additional scores, the subjective quality and app-specific scores that are used to assess the participant's view of the quality of the app and the impact of the app on knowledge, attitudes, intentions, and change in target health behavior, respectively. The higher the score, the more favorable the app quality is.	month 6
Other	Comprehensive Symptom Assessment measured with the Patient-Generated Subjective Global Assessment (PG-SGA)	The PG-SGA is a self-report assessment of symptoms related to cancer and its treatment. This checklist allows clinical care teams to understand the symptom burden that a participant is experiencing. Symptoms are assigned values with low values (e.g., 0) being the lowest symptom burden (favorable).	Weekly over a 3 month (90 day) intervention period
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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