Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2021-02-02
2022-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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Penn State University
OTHER
American Institute for Cancer Research
OTHER
Milton S. Hershey Medical Center
OTHER
Responsible Party
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Kathryn Schmitz
Professor of Public Health Sciences
Principal Investigators
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Kathryn H Schmitz, PhD
Role: PRINCIPAL_INVESTIGATOR
Penn State Milton Hershey Medical Center
Locations
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Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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References
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Schmitz KH, Kanski B, Gordon B, Caru M, Vasakar M, Truica CI, Wang M, Doerksen S, Lorenzo A, Winkels R, Qiu L, Abdullah S. Technology-based supportive care for metastatic breast cancer patients. Support Care Cancer. 2023 Jun 20;31(7):401. doi: 10.1007/s00520-023-07884-3.
Gordon BR, Qiu L, Doerksen SE, Kanski B, Lorenzo A, Truica CI, Vasekar M, Wang M, Winkels RM, Abdullah S, Schmitz KH. Addressing metastatic individuals everyday: Rationale and design of the nurse AMIE for Amazon Echo Show trial among metastatic breast cancer patients. Contemp Clin Trials Commun. 2023 Jan 16;32:101058. doi: 10.1016/j.conctc.2023.101058. eCollection 2023 Apr.
Other Identifiers
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STUDY00016221
Identifier Type: -
Identifier Source: org_study_id
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