NCT04673019

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 2, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

November 24, 2020

Last Update Submit

March 31, 2022

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (21)

  • Physical Function: Short Physical Performance Battery (SPPB)

    baseline

  • Physical Function: Short Physical Performance Battery (SPPB)

    month 3

  • Physical Function: Short Physical Performance Battery (SPPB)

    month 6

  • Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)

    baseline

  • Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)

    month 3

  • +16 more secondary outcomes

Other Outcomes (6)

  • Physical Activity

    Daily for 90 days

  • Usability as measured by the System Usability Scale (SUS)

    month 3

  • Usability as measured by the System Usability Scale (SUS)

    month 6

  • +3 more other outcomes

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

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)

Delayed Intervention

OTHER

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)

Interventions

Nurse AMIE (Addressing Metastatic Individuals Every day)BEHAVIORAL

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 InterventionImmediate Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • ECOG Performance Status score of \>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.
  • Receiving any behavioral intervention.
  • Pregnant
  • Cognitive impairment
  • Life expectancy of less than 6 months as determined by the treating physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (2)

  • 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.

    PMID: 37338627DERIVED

  • 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.

    PMID: 36698743DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kathryn H Schmitz, PhD

    Penn State Milton Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Public Health Sciences

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 17, 2020

Study Start

February 2, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

April 1, 2022

Record last verified: 2022-03

Locations

US(1)