Metastatic Breast CancerNCT04673019
Nurse AMIE for Echo Show: Randomized Control Trial
A study testing Nurse AMIE (Addressing Metastatic Individuals Every day) in people with Metastatic Breast Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The Nurse AMIE platform has been modified for use as an Amazon Alexa skill for use on the Echo Show device. The investigators will recruit women receiving treatment for metastatic breast cancer and randomize patients to receive standard treatment (control) or the Nurse AMIE for Echo Show program. 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?
- Nurse AMIE (Addressing Metastatic Individuals Every day)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2021to 28 Feb 2022
- 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
- Female patient with metastatic breast cancer receiving care at PSCI
- Age: ≥18years of age
- Personal in-home Wi-Fi access
- Personal device capable of receiving telephone calls for weekly study facilitator check-ins
- Fluent in written and spoken English
- Sufficient vision/hearing to use the Alexa Echo Show.
Who cannot join
- ECOG Performance Status score of >2
- Patients with significant medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that in the opinion of the research team exclude the subject from participation.
- Receiving any behavioral intervention.
- Pregnant
- Cognitive impairment
- Life expectancy of less than 6 months as determined by the treating physician
Trial locations and contacts
1 site in 1 country.
About this study
The Nurse AMIE platform has been modified for use as an Amazon Alexa skill for use on the Echo Show device. The investigators will recruit women receiving treatment for metastatic breast cancer and randomize patients to receive standard treatment (control) or the Nurse AMIE for Echo Show program. Nurse AMIE is a supportive care program for women undergoing chemotherapy and helps manage symptoms. The investigators will test the feasibility of using the Nurse AMIE program as well as its effectiveness at managing symptoms.
Read the detailed description
The investigators will recruit 42 MBC patients and randomize them into a partial crossover trial in which immediate treatment group participants receive the Nurse AMIE intervention in full for 3 months, then continue Nurse AMIE (without navigation) for 3 months, while the delayed intervention group will not receive an intervention for 3 months, followed by receiving the Nurse AMIE full intervention with navigation for 3 months. The primary comparisons will be between the immediate treatment and delayed treatment groups over the first 3 months.
Intervention. Participants will all receive an Amazon Echo Show device, WiFi connection (if patients do not already have one), pedometer, and resistance bands. Each day, the participant will open the Nurse AMIE for Echo Show, which will result in the daily greeting. After the greeting, participants will be asked to provide a verbal rating of their symptoms (e.g., pain, sleep, fatigue, and distress).
After completing the symptom survey, Nurse AMIE will use an algorithm to discern which of the intervention modules to offer as assistance for the reported symptoms. These interventions include exercise, guided relaxation, cognitive behavioral therapy, and soothing music. These guideline-based interventions are provided as audio files or YouTube-style videos. In addition, Nurse AMIE provides a daily educational nutrition tip as well as recipes designed to be of interest to people undergoing chemotherapy.
Each week, the participant will receive a phone call from the study navigator. This navigator will monitor symptom ratings daily and will discuss symptoms, interventions, and step goals with the participant each week.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Nurse AMIE (Addressing Metastatic Individuals Every day)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse AMIE (Addressing Metastatic Individuals Every day)Behavioural
Supportive Care Platform (behavioral interventions that are offered based on answers to daily symptom rating questions). Interventions offered include walking, balance, strength exercise, guided relaxation, CBT, DBT, soothing music.
| 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:
* Months 1- 3 (Approximately Day 1-Day 90)
* Participant will receive the Echo Show, a pedometer (to track their steps) and an exercise band (to complete the exercise interventions).
* Use of Nurse AMIE while receiving intervention phone calls from a study facilitator. We are interested in learning whether the phone calls are necessary or if the Nurse AMIE platform can stand alone and see the same effect.
* Months 4-6 (Approximately Day 91-180) o Participant will continue to use Nurse AMIE, but without phone calls from study facilitator Receives: Behavioral: Nurse AMIE (Addressing Metastatic Individuals Every day) |
| Delayed Intervention | Other | The delayed intervention group will receive the intervention 3 months after consent (3 months of no intervention followed by with 3 months of intervention, for a total of 6 months); the participant will follow the pattern listed below:
* Months 1- 3 Approximately (Day 1-Day 90)
o No use of Nurse AMIE
* Months 4-6 (Approximately Day 91-180)
* Participant will receive the Echo Show, a pedometer (to track their steps) and an exercise band (to complete the exercise interventions).
* Use of Nurse AMIE while receiving intervention phone calls from a study facilitator Receives: Behavioral: Nurse AMIE (Addressing Metastatic Individuals Every day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - the proportion of patients who interact with the tablet for at least one month
The proportion of women who consent, take a tablet home, who actually interact with the Nurse AMIE platform at least 30 out of 90 possible days
Measured: 90 days
Acceptability - the proportion of patients who agree to participate
The proportion of women who agree to participate among those deemed eligible and cleared by oncologist.
Measured: baseline
Secondary outcomes (21)
Physical Function: 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.
Measured: baseline
Physical Function: 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.
Measured: month 3
Physical Function: 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.
Measured: month 6
Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)
The SF-36 measures quality of life in the following domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well being, social functioning, pain, and general health. All items are scored from 0 to 100, with 100 being the highest level of functioning possible. Items are averaged to give ratings on each of 8 dimensions.
Measured: baseline
Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)
The SF-36 measures quality of life in the following domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well being, social functioning, pain, and general health. All items are scored from 0 to 100, with 100 being the highest level of functioning possible. Items are averaged to give ratings on each of 8 dimensions.
Measured: month 3
Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)
The SF-36 measures quality of life in the following domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well being, social functioning, pain, and general health. All items are scored from 0 to 100, with 100 being the highest level of functioning possible. Items are averaged to give ratings on each of 8 dimensions.
Measured: month 6
Sleep Quality and Sleep Problems
measured using the Pittsburgh Sleep Quality Inventory. 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.
Measured: baseline
Sleep Quality and Sleep Problems
measured using the Pittsburgh Sleep Quality Inventory. 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.
Measured: month 3
Sleep Quality and Sleep Problems
measured using the Pittsburgh Sleep Quality Inventory. 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.
Measured: month 6
Well-being measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B+4)
This measure is specific to patients with breast cancer and measures well-being in several domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The items are rated from 0 to 4, and total scores for each domain are the sums of the items (0 being low well-being). The total FACT-B score is the sum of the domains, with scores ranging from 0 to 148, with 148 being the highest level of well-being possible.
Measured: baseline
Well-being measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B+4)
This measure is specific to patients with breast cancer and measures well-being in several domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The items are rated from 0 to 4, and total scores for each domain are the sums of the items (0 being low well-being). The total FACT-B score is the sum of the domains, with scores ranging from 0 to 148, with 148 being the highest level of well-being possible.
Measured: month 3
Well-being measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B+4)
This measure is specific to patients with breast cancer and measures well-being in several domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The items are rated from 0 to 4, and total scores for each domain are the sums of the items (0 being low well-being). The total FACT-B score is the sum of the domains, with scores ranging from 0 to 148, with 148 being the highest level of well-being possible.
Measured: month 6
Distress measured using the Penn State Cancer Institute Distress Inventory
The PSCI Distress Inventory is a 5-item questionnaire, which measures distress associated with: practical problems, family problems, emotional problems, spiritual religious concerns, and physical problems. The responses are rated from 0 (no distress) to 10 (severe distress).
Measured: baseline
Distress measured using the Penn State Cancer Institute Distress Inventory
The PSCI Distress Inventory is a 5-item questionnaire, which measures distress associated with: practical problems, family problems, emotional problems, spiritual religious concerns, and physical problems. The responses are rated from 0 (no distress) to 10 (severe distress).
Measured: month 3
Distress measured using the Penn State Cancer Institute Distress Inventory
The PSCI Distress Inventory is a 5-item questionnaire, which measures distress associated with: practical problems, family problems, emotional problems, spiritual religious concerns, and physical problems. The responses are rated from 0 (no distress) to 10 (severe distress).
Measured: month 6
Pain Severity and Pain Interference measured by the Brief Pain Inventory (BPI)
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.
Measured: baseline
Pain Severity and Pain Interference measured by the Brief Pain Inventory (BPI)
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.
Measured: month 3
Pain Severity and Pain Interference measured by the Brief Pain Inventory (BPI)
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.
Measured: month 6
Fatigue measured using the Brief Fatigue Inventory (BFI)
The BFI is a nine-item measure, with scores ranging from 0 being best/no fatigue, and 10 being fatigue as bad as imaginable. A global fatigue score is calculated as an average of the nine items.
Measured: baseline
Fatigue measured using the Brief Fatigue Inventory (BFI)
The BFI is a nine-item measure, with scores ranging from 0 being best/no fatigue, and 10 being fatigue as bad as imaginable. A global fatigue score is calculated as an average of the nine items.
Measured: month 3
Fatigue measured using the Brief Fatigue Inventory (BFI)
The BFI is a nine-item measure, with scores ranging from 0 being best/no fatigue, and 10 being fatigue as bad as imaginable. A global fatigue score is calculated as an average of the nine items.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start2 Feb 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- Model description
- This is a partial crossover trial in which immediate treatment group participants receive the Nurse AMIE intervention in full for 3 months, then continue Nurse AMIE (without navigation) for 3 months, while the delayed intervention group will not receive an intervention for 3 months, followed by receiving the Nurse AMIE full intervention with navigation for 3 months. The primary comparisons will be between the immediate treatment and delayed treatment groups over the first 3 months.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, American Institute for Cancer Research
- Responsible party
- Principal investigator, Kathryn Schmitz, Milton S. Hershey Medical Center
- Investigators
- Kathryn H Schmitz, PhD, Principal investigator, Penn State Milton Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673019
- Sponsor's protocol ID
- STUDY00016221
- Status last verified
- Mar 2022
- First submitted
- 24 Nov 2020
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schmitz KH, Kanski B, Gordon B, Caru M, Vasakar M, Truica CI, Wang M, Doerksen S, Lorenzo A, Winkels R, Qiu L, Abdullah S. Technology-based supportive care for metastatic breast cancer patients. Support Care Cancer. 2023 Jun 20;31(7):401. doi: 10.1007/s00520-023-07884-3.
PubMed 37338627Gordon BR, Qiu L, Doerksen SE, Kanski B, Lorenzo A, Truica CI, Vasekar M, Wang M, Winkels RM, Abdullah S, Schmitz KH. Addressing metastatic individuals everyday: Rationale and design of the nurse AMIE for Amazon Echo Show trial among metastatic breast cancer patients. Contemp Clin Trials Commun. 2023 Jan 16;32:101058. doi: 10.1016/j.conctc.2023.101058. eCollection 2023 Apr.
PubMed 36698743
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse AMIE for Echo Show: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04673019
- Acronym / sponsor ID
- STUDY00016221
- Conditions
- Metastatic Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Penn State University, American Institute for Cancer Research
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 17 Dec 2020 (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.
The Nurse AMIE platform has been modified for use as an Amazon Alexa skill for use on the Echo Show device. The investigators will recruit women receiving treatment for metastatic breast cancer and randomize patients to receive standard treatment (control) or the Nurse AMIE for Echo Show program. Nurse AMIE is a supportive care program for women undergoing chemotherapy and helps manage symptoms. The investigators will test the feasibility of using the Nurse AMIE program as well as its effectiveness at managing symptoms.
Detailed description
The investigators will recruit 42 MBC patients and randomize them into a partial crossover trial in which immediate treatment group participants receive the Nurse AMIE intervention in full for 3 months, then continue Nurse AMIE (without navigation) for 3 months, while the delayed intervention group will not receive an intervention for 3 months, followed by receiving the Nurse AMIE full intervention with navigation for 3 months. The primary comparisons will be between the immediate treatment and delayed treatment groups over the first 3 months.
Intervention. Participants will all receive an Amazon Echo Show device, WiFi connection (if patients do not already have one), pedometer, and resistance bands. Each day, the participant will open the Nurse AMIE for Echo Show, which will result in the daily greeting. After the greeting, participants will be asked to provide a verbal rating of their symptoms (e.g., pain, sleep, fatigue, and distress).
After completing the symptom survey, Nurse AMIE will use an algorithm to discern which of the intervention modules to offer as assistance for the reported symptoms. These interventions include exercise, guided relaxation, cognitive behavioral therapy, and soothing music. These guideline-based interventions are provided as audio files or YouTube-style videos. In addition, Nurse AMIE provides a daily educational nutrition tip as well as recipes designed to be of interest to people undergoing chemotherapy.
Each week, the participant will receive a phone call from the study navigator. This navigator will monitor symptom ratings daily and will discuss symptoms, interventions, and step goals with the participant each week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a partial crossover trial in which immediate treatment group participants receive the Nurse AMIE intervention in full for 3 months, then continue Nurse AMIE (without navigation) for 3 months, while the delayed intervention group will not receive an intervention for 3 months, followed by receiving the Nurse AMIE full intervention with navigation for 3 months. The primary comparisons will be between the immediate treatment and delayed treatment groups over the first 3 months.
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Nurse AMIE (Addressing Metastatic Individuals Every day)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: * Months 1- 3 (Approximately Day 1-Day 90) * Participant will receive the Echo Show, a pedometer (to track their steps) and an exercise band (to complete the exercise interventions). * Use of Nurse AMIE while receiving intervention phone calls from a study facilitator. We are interested in learning whether the phone calls are necessary or if the Nurse AMIE platform can stand alone and see the same effect. * Months 4-6 (Approximately Day 91-180) o Participant will continue to use Nurse AMIE, but without phone calls from study facilitator |
| Delayed Intervention | Other | Behavioral: Nurse AMIE (Addressing Metastatic Individuals Every day)The delayed intervention group will receive the intervention 3 months after consent (3 months of no intervention followed by with 3 months of intervention, for a total of 6 months); the participant will follow the pattern listed below: * Months 1- 3 Approximately (Day 1-Day 90) o No use of Nurse AMIE * Months 4-6 (Approximately Day 91-180) * Participant will receive the Echo Show, a pedometer (to track their steps) and an exercise band (to complete the exercise interventions). * Use of Nurse AMIE while receiving intervention phone calls from a study facilitator |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patient with metastatic breast cancer receiving care at PSCI
- Age: ≥18years of age
- Personal in-home Wi-Fi access
- Personal device capable of receiving telephone calls for weekly study facilitator check-ins
- Fluent in written and spoken English
Key exclusion criteria (6 listed)
- ECOG Performance Status score of >2
- Patients with significant medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that in the opinion of the research team exclude the subject from participation.
- Receiving any behavioral intervention.
- Pregnant
- Cognitive impairment
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 |
|---|---|---|
| Nurse AMIE (Addressing Metastatic Individuals Every day)Supportive Care Platform (behavioral interventions that are offered based on answers to daily symptom rating questions). Interventions offered include walking, balance, strength exercise, guided relaxation, CBT, DBT, soothing music. | Behavioural | Delayed Intervention, Immediate Intervention |
Primary outcome
Feasibility - the proportion of patients who interact with the tablet for at least one month
Time frame: 90 days
The proportion of women who consent, take a tablet home, who actually interact with the Nurse AMIE platform at least 30 out of 90 possible days
Acceptability - the proportion of patients who agree to participate
Time frame: baseline
The proportion of women who agree to participate among those deemed eligible and cleared by oncologist.
21 secondary outcomes
Physical Function: Short Physical Performance Battery (SPPB)
Time frame: baseline
Physical Function: Short Physical Performance Battery (SPPB)
Time frame: month 3
Physical Function: Short Physical Performance Battery (SPPB)
Time frame: month 6
Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)
Time frame: baseline
Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)
Time frame: month 3
Health-Related Quality of Life measured using the 36-Item Short Form Health Survey (SF-36)
Time frame: month 6
Sleep Quality and Sleep Problems
Time frame: baseline
Sleep Quality and Sleep Problems
Time frame: month 3
Sleep Quality and Sleep Problems
Time frame: month 6
Well-being measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B+4)
Time frame: baseline
Well-being measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B+4)
Time frame: month 3
Well-being measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B+4)
Time frame: month 6
Distress measured using the Penn State Cancer Institute Distress Inventory
Time frame: baseline
Distress measured using the Penn State Cancer Institute Distress Inventory
Time frame: month 3
Distress measured using the Penn State Cancer Institute Distress Inventory
Time frame: month 6
Pain Severity and Pain Interference measured by the Brief Pain Inventory (BPI)
Time frame: baseline
Pain Severity and Pain Interference measured by the Brief Pain Inventory (BPI)
Time frame: month 3
Pain Severity and Pain Interference measured by the Brief Pain Inventory (BPI)
Time frame: month 6
Fatigue measured using the Brief Fatigue Inventory (BFI)
Time frame: baseline
Fatigue measured using the Brief Fatigue Inventory (BFI)
Time frame: month 3
Fatigue measured using the Brief Fatigue Inventory (BFI)
Time frame: month 6
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 1 Apr 2022.
- Derived from this study: PubMed 37338627Schmitz KH, Kanski B, Gordon B, Caru M, Vasakar M, Truica CI, Wang M, Doerksen S, Lorenzo A, Winkels R, Qiu L, Abdullah S. Technology-based supportive care for metastatic breast cancer patients. Support Care Cancer. 2023 Jun 20;31(7):401. doi: 10.1007/s00520-023-07884-3.
- Derived from this study: PubMed 36698743Gordon BR, Qiu L, Doerksen SE, Kanski B, Lorenzo A, Truica CI, Vasekar M, Wang M, Winkels RM, Abdullah S, Schmitz KH. Addressing metastatic individuals everyday: Rationale and design of the nurse AMIE for Amazon Echo Show trial among metastatic breast cancer patients. Contemp Clin Trials Commun. 2023 Jan 16;32:101058. doi: 10.1016/j.conctc.2023.101058. eCollection 2023 Apr.
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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 Milton Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse AMIE (Addressing Metastatic Individuals Every day) 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 6 inclusion and 6 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 1 Apr 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 - the proportion of patients who interact with the tablet for at least one month (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04673019, which also lists 2 linked publications.
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 1 Apr 2022.