Clinical trial NCT03975621: Nurse AMIE: Addressing Metastatic Individuals Everyday
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
Keywords: Exercise
Feasibility
Acceptability
Supportive Care Platform
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determine the acceptability and feasibility of a supportive care software platform to improve quality of life and function in metastatic breast cancer patients. Acceptability will be defined as the proportion of women offered the intervention who agree to participate. Feasibility will be defined as 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.

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 phone calls 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:

* Women with metastatic breast cancer
* ECOG performance score ≤3.
* English Speaking
* With sufficient vision/hearing or family support
* Willingness to be randomized

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

Primary outcomes:
measure: Feasibility of the Application: 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.
timeFrame: 3 Months
Secondary outcomes:
measure: Acceptability of the Application: The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.
timeFrame: 3 Months
Other outcomes:
measure: Quality of Life: Short Form 36
timeFrame: Through study completion, an average of 9 months
measure: Quality of Life: Functional Assessment of Cancer Therapy- Breast
timeFrame: Through study completion, an average of 9 months
measure: Physical Function: Short Physical Performance Battery
timeFrame: Through study completion, an average of 9 months
measure: Sleep: Sleep Quality Assessment (PSQI)
timeFrame: Through study completion, an average of 9 months
measure: Pain: Brief Pain Inventory (Short Form)
timeFrame: Through study completion, an average of 9 months
measure: Fatigue: Brief Fatigue Inventory
timeFrame: Through study completion, an average of 9 months
Locations:
city: Hershey
country: United States
facility: Penn State Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Kathryn H Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: