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Completed

NCT Number: NCT03456973

Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer

The investigators propose to build and test a supportive care software platform called Nurse AMIE (Addressing Metastatic Individuals Everyday) to be provided to metastatic breast cancer patients on Android Tablets. This program will be tested in 50 metastatic breast cancer patients within the Penn State Cancer Institute's 28 county catchment area. The company with whom the investigator will partner to develop this application is already working with multiple investigators at the institution (Webster Group).

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

About this study

Goals of the Nurse AMIE software program are to regularly assess psychosocial, functional, and symptom needs among metastatic breast cancer patients and to provide appropriate interventions via YouTube style videos, weekly Skype calls (face to face, tablet to tablet) with a patient navigator at Penn State, and appropriate referrals to phone or in person consultations as needed. The proposed Nurse AMIE software program will allow for the provision of resources (YouTube style videos, audio files, exercises) to intervene on many of the common symptoms and challenges experienced by metastatic patients. This is an identified need on the part of both metastatic patients and their medical care teams. Finally, it will also allow patient navigators to check in with patients, reviewing responses to surveys, discerning whether new or different interventions are needed, and connecting women to palliative care and other services if additional care is warranted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with metastatic breast cancer
  • ECOG performance score ≤3.
  • English Speaking
  • With sufficient vision/hearing or family support

Exclusion criteria

  • Medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction).
  • Patients who are receiving any other behavioral intervention

Treatment and study plan

Nurse AMIE

Behavioral

Supportive care software platform

Primary outcomes

  1. Feasibility- the proportion of patients who interact at least one month with tablet.

    Time frame: 3 months

    The proportion of women who consent, take a tablet home, who actually interact with the tablet and participate at least one month of the program.

Secondary outcomes

  1. Acceptability - the proportion of patients who agree to participate

    Time frame: 3 months

    The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.

Other outcomes

  1. Examine the effects of the program on quality of life

    Time frame: 3 months

    This will be compared using surveys at the beginning and end of the study period (3 months)

  2. Qualitative assessment of physician, patient, and navigator endorsement of the program.

    Time frame: 1 month.

    At the conclusion of the study, physicians, patients and navigators will be asked semi-structured qualitative questions

  3. Physical Function: Short Physical Performance Battery

    Time frame: 9 months

    Objectively-measured physical function will be assessed using the 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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Avon Foundation

Registry information

Official study title

Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)

Acronym: NurseAMIE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2018
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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