Clinical trial NCT03456973: Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer
Official title: Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Breast Cancer
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Avon Foundation
First posted: 2018-03-07
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility 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

Primary outcomes:
measure: Feasibility- the proportion of patients who interact at least one month with tablet.
timeFrame: 3 months
Secondary outcomes:
measure: Acceptability - the proportion of patients who agree to participate
timeFrame: 3 months
Other outcomes:
measure: Examine the effects of the program on quality of life
timeFrame: 3 months
measure: Qualitative assessment of physician, patient, and navigator endorsement of the program.
timeFrame: 1 month.
measure: Physical Function: Short Physical Performance Battery
timeFrame: 9 months
Locations:
city: Hershey
country: United States
facility: Penn State Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Kathryn H Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.