Metastatic Breast CancerNurseAMIENCT03975621
Nurse AMIE: Addressing Metastatic Individuals Everyday
A study testing Supportive Care in people with Metastatic Breast Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Supportive Care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with metastatic breast cancer
- ECOG performance score ≤3.
- English Speaking
- With sufficient vision/hearing or family support
- Willingness to be randomized
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Cancer Institute
Hershey, Pennsylvania, 17033
About this study
Official title: Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)
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.
Read the 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Supportive Care
- Keywords
- Exercise, Feasibility, Acceptability, Supportive Care Platform
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | 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. Receives: Behavioral: Supportive Care |
| Delayed Intervention | Experimental | 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. Receives: Behavioral: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months
Secondary outcomes (1)
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.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Mar 2019
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Schmitz, Milton S. Hershey Medical Center
- Investigators
- Kathryn H Schmitz, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975621
- Sponsor's protocol ID
- STUDY00011444
- Acronym
- NurseAMIE
- Status last verified
- Jan 2022
- First submitted
- 4 Jun 2019
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)
- ClinicalTrials.gov ID
- NCT03975621
- Acronym / sponsor ID
- NurseAMIE / STUDY00011444
- Conditions
- Metastatic Breast Cancer
- Keywords
- Exercise, Feasibility, Acceptability, Supportive Care Platform
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Supportive CareThe 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. |
| Delayed Intervention | Experimental | Behavioral: Supportive CareThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women with metastatic breast cancer
- ECOG performance score ≤3.
- English Speaking
- With sufficient vision/hearing or family support
- Willingness to be randomized
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive CarePatient 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. | Behavioural | Delayed Intervention, Immediate Intervention |
Primary outcome
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.
1 secondary outcome
Acceptability of the Application: The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn H Schmitz, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Care in people with Metastatic Breast Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.