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Nurse AMIE: Addressing Metastatic Individuals Everyday (NurseAMIE)

Primary Purpose

Metastatic Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supportive Care
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metastatic Breast Cancer focused on measuring Exercise, Feasibility, Acceptability, Supportive Care Platform

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate Intervention

Delayed Intervention

Arm Description

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. Patients will receive the tablet, a pedometer and an exercise band. Patients will use Nurse AMIE while receiving weekly phone calls from a patient navigator. After 90 days of the intervention observation will take place for 90 days, the patient will be asked to continue using Nurse AMIE without a patient navigator's presence.

The delayed intervention group will receive the intervention 3 months after consent (6 months of intervention with 3 months delay total of 9 months); the patient will then follow the same pattern as listed above. The only difference is we will ask the delayed intervention group to wear a FitBit device for 1 week following consent in order to gain baseline data as to their activity/movement.

Outcomes

Primary Outcome Measures

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.
Feasibility is 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.

Secondary Outcome Measures

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

Full Information

First Posted
June 4, 2019
Last Updated
January 19, 2022
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03975621
Brief Title
Nurse AMIE: Addressing Metastatic Individuals Everyday
Acronym
NurseAMIE
Official Title
Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
Exercise, Feasibility, Acceptability, Supportive Care Platform

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention
Arm Type
Experimental
Arm Description
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. Patients will receive the tablet, a pedometer and an exercise band. Patients will use Nurse AMIE while receiving weekly phone calls from a patient navigator. After 90 days of the intervention observation will take place for 90 days, the patient will be asked to continue using Nurse AMIE without a patient navigator's presence.
Arm Title
Delayed Intervention
Arm Type
Experimental
Arm Description
The delayed intervention group will receive the intervention 3 months after consent (6 months of intervention with 3 months delay total of 9 months); the patient will then follow the same pattern as listed above. The only difference is we will ask the delayed intervention group to wear a FitBit device for 1 week following consent in order to gain baseline data as to their activity/movement.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Care
Intervention Description
Patient will receive the tablet, a pedometer (to track their steps) and an exercise band (to complete the exercise videos). Use of Nurse AMIE while receiving intervention phone calls from a patient navigator. After 90 days, observation begins and the patient will be asked to continue using Nurse AMIE without a patient navigator's presence.
Primary Outcome Measure Information:
Title
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.
Description
Feasibility is 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.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Acceptability of the Application: The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.
Description
The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.
Time Frame
3 Months
Other Pre-specified Outcome Measures:
Title
Quality of Life: Short Form 36
Description
The Short Form 36 Health Survey (SF-36) is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and an abbreviated variant of it. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
Through study completion, an average of 9 months
Title
Quality of Life: Functional Assessment of Cancer Therapy- Breast
Description
The Functional Assessment of Cancer Therapy-Breast (FACT-B), is a 44-item self-report instrument designed to measure multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B questionnaire includes 44 items, consisting of 5 subscales, all subscale items are summed to a total. The higher the score the better QOL
Time Frame
Through study completion, an average of 9 months
Title
Physical Function: Short Physical Performance Battery
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Sleep: Sleep Quality Assessment (PSQI)
Description
Sleep quality and sleep problems will be assessed with the validated and frequently used Pittsburgh Sleep Quality Index (PSQI). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Time Frame
Through study completion, an average of 9 months
Title
Pain: Brief Pain Inventory (Short Form)
Description
Bodily pain will be assessed using the Brief Pain Inventory- Short form (BPI-SF). The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70.
Time Frame
Through study completion, an average of 9 months
Title
Fatigue: Brief Fatigue Inventory
Description
The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue. An increasing focus on cancer-related fatigue emphasized the need for sensitive tools to assess this most frequently reported symptom. The six interference items correlate with standard quality-of-life measures.
Time Frame
Through study completion, an average of 9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn H Schmitz, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Cancer Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Nurse AMIE: Addressing Metastatic Individuals Everyday

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