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Nurse AMIE: Addressing Metastatic Individuals Everyday (NurseAMIE)

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ClinicalTrials.gov Identifier: NCT03975621
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Kathryn Schmitz, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Behavioral: Supportive Care 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel 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 : March 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate Intervention
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.
Behavioral: Supportive Care

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.


Experimental: Delayed Intervention
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.
Behavioral: Supportive Care

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 Measures :
  1. 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. [ Time Frame: 3 Months ]
    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 :
  1. Acceptability of the Application: The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist. [ Time Frame: 3 Months ]
    The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.


Other Outcome Measures:
  1. Quality of Life: Short Form 36 [ Time Frame: Through study completion, an average of 9 months ]

    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.


  2. Quality of Life: Functional Assessment of Cancer Therapy- Breast [ Time Frame: Through study completion, an average of 9 months ]

    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


  3. Physical Function: Short Physical Performance Battery [ Time Frame: Through study completion, an average of 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.

  4. Sleep: Sleep Quality Assessment (PSQI) [ Time Frame: Through study completion, an average of 9 months ]

    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.


  5. Pain: Brief Pain Inventory (Short Form) [ Time Frame: Through study completion, an average of 9 months ]

    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.


  6. Fatigue: Brief Fatigue Inventory [ Time Frame: Through study completion, an average of 9 months ]
    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.



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975621


Contacts
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Contact: Erica A Schleicher, MS 717-531-0003 ext 323324 eschleicher1@phs.psu.edu
Contact: Shawna Doerksen, PhD 717-531-0003 ext 7678 sdoerksen@phs.psu.edu

Locations
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United States, Pennsylvania
Penn State Cancer Institute Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Erica A Schleicher, MS    717-531-0003 ext 323324    eschleicher1@phs.psu.edu   
Contact: Shawna Doerksen, PhD    717-531-0003 ext 7678    sdoerksen@phs.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Kathryn H Schmitz, PhD Penn State University

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Responsible Party: Kathryn Schmitz, Professor, Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03975621     History of Changes
Other Study ID Numbers: STUDY00011444
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Kathryn Schmitz, Milton S. Hershey Medical Center:
Exercise
Feasibility
Acceptability
Supportive Care Platform

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases