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

• ClinicalTrials.gov Identifier: NCT03456973
• Recruitment Status: Completed
• First Posted: March 7, 2018
• Last Update Posted: May 3, 2019
• Sponsor: Milton S. Hershey Medical Center
• Collaborator: Avon Foundation
• Information provided by (Responsible Party): Kathryn Schmitz, Milton S. Hershey Medical Center

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Metastatic Breast Cancer	Behavioral: Nurse AMIE	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)
• Actual Study Start Date: October 1, 2017
• Actual Primary Completion Date: April 18, 2018
• Actual Study Completion Date: April 18, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nurse AMIE	Behavioral: Nurse AMIE; Supportive care software platform

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. 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).
2. Patients who are receiving any other behavioral intervention

Contacts and Locations

Locations

United States, Pennsylvania

Penn State Cancer Institute

Hershey, Pennsylvania, United States, 17033

Sponsors and Collaborators

Milton S. Hershey Medical Center

Avon Foundation

Investigators

• Principal Investigator: Kathryn H Schmitz, PhD; Penn State College of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Oostra DL, Burse NR, Wolf LJ, Schleicher E, Mama SK, Bluethmann S, Schmitz K, Winkels RM. Understanding Nutritional Problems of Metastatic Breast Cancer Patients: Opportunities for Supportive Care Through eHealth. Cancer Nurs. 2021 Mar-Apr 01;44(2):154-162. doi: 10.1097/NCC.0000000000000788.

• Responsible Party: Kathryn Schmitz, Professor, Public Health Sciences, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT03456973
• Other Study ID Numbers: STUDY00006544
• First Posted: March 7, 2018
• Last Update Posted: May 3, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases