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Nurse AMIE for Echo Show: Randomized Control Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04673019
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : February 24, 2021
Sponsor:
Collaborators:
Penn State University
American Institute for Cancer Research
Information provided by (Responsible Party):
Kathryn Schmitz, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Behavioral: Nurse AMIE (Addressing Metastatic Individuals Every day) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Nurse AMIE for Echo Show: Randomized Control Trial
Actual Study Start Date : February 2, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate Intervention

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)
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.

Delayed Intervention

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)
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.




Primary Outcome Measures :
  1. Feasibility - the proportion of patients who interact with the tablet for at least one month [ Time Frame: 90 days ]
    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

  2. Acceptability - the proportion of patients who agree to participate [ Time Frame: baseline ]
    The proportion of women who agree to participate among those deemed eligible and cleared by oncologist.


Secondary Outcome Measures :
  1. Physical Function: Short Physical Performance Battery (SPPB) [ Time Frame: baseline ]
    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.

  2. Physical Function: Short Physical Performance Battery (SPPB) [ Time Frame: month 3 ]
    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.

  3. Physical Function: Short Physical Performance Battery (SPPB) [ Time Frame: month 6 ]
    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.

  4. Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36) [ Time Frame: baseline ]
    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.

  5. Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36) [ Time Frame: month 3 ]
    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.

  6. Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36) [ Time Frame: month 6 ]
    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.

  7. Sleep Quality and Sleep Problems [ Time Frame: baseline ]
    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.

  8. Sleep Quality and Sleep Problems [ Time Frame: month 3 ]
    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.

  9. Sleep Quality and Sleep Problems [ Time Frame: month 6 ]
    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.

  10. Well-being measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B+4) [ Time Frame: baseline ]
    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.

  11. Well-being measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B+4) [ Time Frame: month 3 ]
    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.

  12. Well-being measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B+4) [ Time Frame: month 6 ]
    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.

  13. Distress measured using the Penn State Cancer Institute Distress Inventory [ Time Frame: baseline ]
    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).

  14. Distress measured using the Penn State Cancer Institute Distress Inventory [ Time Frame: month 3 ]
    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).

  15. Distress measured using the Penn State Cancer Institute Distress Inventory [ Time Frame: month 6 ]
    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).

  16. Pain Severity and Pain Interference measured by the Brief Pain Inventory (BPI) [ Time Frame: baseline ]
    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.

  17. Pain Severity and Pain Interference measured by the Brief Pain Inventory (BPI) [ Time Frame: month 3 ]
    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.

  18. Pain Severity and Pain Interference measured by the Brief Pain Inventory (BPI) [ Time Frame: month 6 ]
    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.

  19. Fatigue measured using the Brief Fatigue Inventory (BFI) [ Time Frame: baseline ]
    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.

  20. Fatigue measured using the Brief Fatigue Inventory (BFI) [ Time Frame: month 3 ]
    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.

  21. Fatigue measured using the Brief Fatigue Inventory (BFI) [ Time Frame: month 6 ]
    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.


Other Outcome Measures:
  1. Physical Activity [ Time Frame: Daily for 90 days ]
    measured using step counts recorded with an analog pedometer, self-reported to the Nurse AMIE platform by the participant each day

  2. Usability as measured by the System Usability Scale (SUS) [ Time Frame: month 3 ]
    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.

  3. Usability as measured by the System Usability Scale (SUS) [ Time Frame: month 6 ]
    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.

  4. App Quality measured by the Mobile Application Rating Scale (U-MARS) [ Time Frame: month 3 ]
    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.

  5. App Quality measured by the Mobile Application Rating Scale (U-MARS) [ Time Frame: month 6 ]
    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.

  6. Comprehensive Symptom Assessment measured with the Patient-Generated Subjective Global Assessment (PG-SGA) [ Time Frame: Weekly over a 3 month (90 day) intervention period ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673019


Contacts
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Contact: Shawna E Doerksen, PhD 717-531-0003 ext 323424 sdoerksen@phs.psu.edu
Contact: Bethany Kanski, MS 717-531-0003 ext 323424 bkanski@phs.psu.edu

Locations
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United States, Pennsylvania
Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Bethany Kanski, MS    717-531-0003 ext 323424    bkanski@phs.psu.edu   
Contact: Shawna Doerksen, PhD    8148629099    sdoerksen@phs.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Penn State University
American Institute for Cancer Research
Investigators
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Principal Investigator: Kathryn H Schmitz, PhD Penn State Milton Hershey Medical Center
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Responsible Party: Kathryn Schmitz, Professor of Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04673019    
Other Study ID Numbers: STUDY00016221
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No