Breast CancerPATHNCT03212079
Physical Activities by Technology Help (PATH)
A study testing Mycoach Smart Text and MyCoach on Amazon Alexa in people with Breast Cancer and Prostate Cancer, run by Johns Hopkins University at 1 site in United States.
Trial summary
PATH is a research study for cancer survivors to help participants to become more active. Studies suggested an association between inactivity and cancer. The investigators created new novel ways and technologies that may help participants to become more active. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Lung Cancer
- What is being tested?
- Mycoach Smart Text and MyCoach on Amazon Alexa
- 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
- 3 Apr 2017to 30 Jun 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A cancer survivor of breast, prostate, lung, colorectal, cervical or oral cancer survivor and live within the Baltimore Maryland area.
- Finished your active cancer treatment at least three months ago.
- Overweight or obese and do not exercise daily.
- Do not have any physical limitation to do mild to moderate physical activities.
- Have a smart phone (iPhone or Android device) with Wi-Fi internet connection at home.
- Actively using an email account
Show all 12Show fewer
- Willing to accept the random study assignment.
- Willing to wear a Fitbit band 'a physical activity tracking device' on your wrist for five weeks every single day.
- Willing to have an Echo speaker 'a smart home speaker with voice assistant' installed in your home and use the digital voice assist for four weeks.
- Willing to receive daily text messages on your phone for four weeks.
- Willing to provide us with access to your Fitbit physical activities data.
- Willing to sign the consent form.
Who cannot join
- Already doing moderate to high physical activities in their daily life (rapid screener).
- Planning to relocate within the next 4-5 weeks.
- Stage 4 cancer.
- Already using physical activity tracker or part of a physical activity program.
- Part of another study that may interfere with our outcome of interest, unstable mental condition.
- Mental condition that prevents patient from performing the study activities and requirements.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: Novel Individualized Intervention for Behavioral Change Among High-Risk Group Cancer Survivors : Physical Activities by Technology Help (PATH)
PATH is a research study for cancer survivors to help participants to become more active. Studies suggested an association between inactivity and cancer. The investigators created new novel ways and technologies that may help participants to become more active. The three methods the investigators are studying are: 1) participant become active on her/his own; educational material will be provided; 2) working with a programmed health coach over the phone via text messages; and 3) using digital voice assist to help participant become more active. The digital voice assist will be delivered via Amazon Alexa on Echo speaker (it is the famous intelligent voice that you see in superball commercial by Alec Baldwin). This study is funded by the State of Maryland.
Read the detailed description
If the participant agree to be in this study, the investigators will ask the participant to do the following things:
The participant will be asked questions about his/her physical activity (walking, running or other exercise) to determine if he/she are eligible to participate. If the participant is eligible and interested in participating, the investigators will ask hi/her to read and sign the consent form.
After that, the investigators will randomly assign the participant to a research group (this method would be similar to drawing numbers from a hat). The result will determine which group the participant will belong to. The study would have three different groups:
- Group one will be self-motivated to be physically active (control group)
- The second group will receive smart daily text messages only (text group);
- The last group would have the Amazon Echo smart device installed in participants' homes and they will interact with a digital voice assist that will help them be active (Alexa group).
- All study participants will receive a Fitbit device which you can keep after the study.
- When the investigators start the study, the participant will be asked to start wearing wrist device immediately. For the next one week the investigators will monitor the participant daily number of steps to establish how active he/she is. The participant will not be required to change his/her daily routine in the first week.
- After the end of the first week, the investigators will ask the participant to increase his/her daily steps to at least 10 thousand steps per day for the next four weeks. In total the participant will have one week of hi/her normal daily routine and four weeks of trying to do 10 thousand steps per day or more.
- If the participant is in the control group, the investigators will ask you to try to do 10 thousand steps per day on his/her own.
- If the participant are in the text group, he/she will get smart text messages with healthy tips to help track his/her activities and reach his/her daily goal.
- If the participant is in Alexa group, a study member will visit the participant at his/her home before the end of the first week to install the Echo smart speaker and to explain to the participant how to use the voice assist to help him/her become more active for the next four weeks.
- Conditions
- Breast Cancer, Prostate Cancer, Lung Cancer, Colorectal Cancer, Cervical Cancer, Oral Cancer
- Being tested
- Mycoach Smart Text, MyCoach on Amazon Alexa
- Keywords
- Cancer Survivors, Physical Activities, Baltimore, State of Maryland
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Uterine Cervical Neoplasms, Mouth Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycoach Smart TextBehavioural
Also called Smart text
Personalized text messages to you cellphone to help you become more active
MyCoach on Amazon AlexaBehavioural
Also called Digital Voice Assist
This is an intelligent voice that you can communicate with via Amazon echo speaker
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The participant will self motivate hi/herself to increase physical activities. |
| Mycoach Smart Text | Experimental | The participant will receive personalized smart text messages to encourage him/her to increase physical activities Receives: Behavioral: Mycoach Smart Text |
| MyCoach via Amazon Alexa | Experimental | The participant will interact with intelligent coach on Amazon Alexa (a digital voice assist) to help him/her become more active Receives: Behavioral: MyCoach on Amazon Alexa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of steps. Wearable sensor based
The investigators will measure your physical activity by number of steps before and after intervention via wearable activity tracker.
Measured: 5 weeks
Secondary outcomes (3)
Total number and duration of activity bouts. Wearable sensor based
Defined as 3 min. or more of uninterrupted activity measured by wearable sensor.
Measured: 5 weeks
Transitions between active/inactive periods. Wearable sensor based
Time spent walking vs time spent sitting measured by all in one sensor.
Measured: 5 weeks
Daily patterns of activity. Wearable sensor based
Distribution parameter of number of steps per/minute within 24 hours period. Measured by all in one sensor.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start3 Apr 2017
- Primary completion15 Mar 2018
- Study completion30 Jun 2018
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single center three arms randomized trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Hassoon, MD,MPH,PMP, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212079
- Sponsor's protocol ID
- IRB00113882
- Acronym
- PATH
- Status last verified
- Aug 2018
- First submitted
- 4 Apr 2017
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hassoon A, Baig Y, Naiman DQ, Celentano DD, Lansey D, Stearns V, Coresh J, Schrack J, Martin SS, Yeh HC, Zeilberger H, Appel LJ. Randomized trial of two artificial intelligence coaching interventions to increase physical activity in cancer survivors. NPJ Digit Med. 2021 Dec 9;4(1):168. doi: 10.1038/s41746-021-00539-9.
PubMed 34887491Hassoon A, Schrack J, Naiman D, Lansey D, Baig Y, Stearns V, Celentano D, Martin S, Appel L. Increasing Physical Activity Amongst Overweight and Obese Cancer Survivors Using an Alexa-Based Intelligent Agent for Patient Coaching: Protocol for the Physical Activity by Technology Help (PATH) Trial. JMIR Res Protoc. 2018 Feb 12;7(2):e27. doi: 10.2196/resprot.9096.
PubMed 29434016
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Individualized Intervention for Behavioral Change Among High-Risk Group Cancer Survivors : Physical Activities by Technology Help (PATH)
- ClinicalTrials.gov ID
- NCT03212079
- Acronym / sponsor ID
- PATH / IRB00113882
- Conditions
- Breast Cancer, Prostate Cancer, Lung Cancer, Colorectal Cancer, Cervical Cancer, Oral Cancer
- Keywords
- Cancer Survivors, Physical Activities, Baltimore, State of Maryland
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 11 Jul 2017 (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.
PATH is a research study for cancer survivors to help participants to become more active. Studies suggested an association between inactivity and cancer. The investigators created new novel ways and technologies that may help participants to become more active. The three methods the investigators are studying are: 1) participant become active on her/his own; educational material will be provided; 2) working with a programmed health coach over the phone via text messages; and 3) using digital voice assist to help participant become more active. The digital voice assist will be delivered via Amazon Alexa on Echo speaker (it is the famous intelligent voice that you see in superball commercial by Alec Baldwin). This study is funded by the State of Maryland.
Detailed description
If the participant agree to be in this study, the investigators will ask the participant to do the following things:
The participant will be asked questions about his/her physical activity (walking, running or other exercise) to determine if he/she are eligible to participate. If the participant is eligible and interested in participating, the investigators will ask hi/her to read and sign the consent form.
After that, the investigators will randomly assign the participant to a research group (this method would be similar to drawing numbers from a hat). The result will determine which group the participant will belong to. The study would have three different groups:
- Group one will be self-motivated to be physically active (control group)
- The second group will receive smart daily text messages only (text group);
- The last group would have the Amazon Echo smart device installed in participants' homes and they will interact with a digital voice assist that will help them be active (Alexa group).
- All study participants will receive a Fitbit device which you can keep after the study.
- When the investigators start the study, the participant will be asked to start wearing wrist device immediately. For the next one week the investigators will monitor the participant daily number of steps to establish how active he/she is. The participant will not be required to change his/her daily routine in the first week.
- After the end of the first week, the investigators will ask the participant to increase his/her daily steps to at least 10 thousand steps per day for the next four weeks. In total the participant will have one week of hi/her normal daily routine and four weeks of trying to do 10 thousand steps per day or more.
- If the participant is in the control group, the investigators will ask you to try to do 10 thousand steps per day on his/her own.
- If the participant are in the text group, he/she will get smart text messages with healthy tips to help track his/her activities and reach his/her daily goal.
- If the participant is in Alexa group, a study member will visit the participant at his/her home before the end of the first week to install the Echo smart speaker and to explain to the participant how to use the voice assist to help him/her become more active for the next four weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a single center three arms randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The participant will self motivate hi/herself to increase physical activities. |
| Mycoach Smart Text | Experimental | Behavioral: Mycoach Smart TextThe participant will receive personalized smart text messages to encourage him/her to increase physical activities |
| MyCoach via Amazon Alexa | Experimental | Behavioral: MyCoach on Amazon AlexaThe participant will interact with intelligent coach on Amazon Alexa (a digital voice assist) to help him/her become more active |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A cancer survivor of breast, prostate, lung, colorectal, cervical or oral cancer survivor and live within the Baltimore Maryland area.
- Finished your active cancer treatment at least three months ago.
- Overweight or obese and do not exercise daily.
- Do not have any physical limitation to do mild to moderate physical activities.
- Have a smart phone (iPhone or Android device) with Wi-Fi internet connection at home.
Key exclusion criteria (7 listed)
- Already doing moderate to high physical activities in their daily life (rapid screener).
- Planning to relocate within the next 4-5 weeks.
- Stage 4 cancer.
- Already using physical activity tracker or part of a physical activity program.
- Part of another study that may interfere with our outcome of interest, unstable mental condition.
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 |
|---|---|---|
| Mycoach Smart TextAlso: Smart textPersonalized text messages to you cellphone to help you become more active | Behavioural | Mycoach Smart Text |
| MyCoach on Amazon AlexaAlso: Digital Voice AssistThis is an intelligent voice that you can communicate with via Amazon echo speaker | Behavioural | MyCoach via Amazon Alexa |
Primary outcome
Average number of steps. Wearable sensor based
Time frame: 5 weeks
The investigators will measure your physical activity by number of steps before and after intervention via wearable activity tracker.
3 secondary outcomes
Total number and duration of activity bouts. Wearable sensor based
Time frame: 5 weeks
Transitions between active/inactive periods. Wearable sensor based
Time frame: 5 weeks
Daily patterns of activity. Wearable sensor based
Time frame: 5 weeks
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 7 Aug 2018.
- Derived from this study: PubMed 34887491Hassoon A, Baig Y, Naiman DQ, Celentano DD, Lansey D, Stearns V, Coresh J, Schrack J, Martin SS, Yeh HC, Zeilberger H, Appel LJ. Randomized trial of two artificial intelligence coaching interventions to increase physical activity in cancer survivors. NPJ Digit Med. 2021 Dec 9;4(1):168. doi: 10.1038/s41746-021-00539-9.
- Derived from this study: PubMed 29434016Hassoon A, Schrack J, Naiman D, Lansey D, Baig Y, Stearns V, Celentano D, Martin S, Appel L. Increasing Physical Activity Amongst Overweight and Obese Cancer Survivors Using an Alexa-Based Intelligent Agent for Patient Coaching: Protocol for the Physical Activity by Technology Help (PATH) Trial. JMIR Res Protoc. 2018 Feb 12;7(2):e27. doi: 10.2196/resprot.9096.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Hassoon, MD,MPH,PMP principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mycoach Smart Text and MyCoach on Amazon Alexa in people with Breast Cancer and Prostate Cancer, run by Johns Hopkins University 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 12 inclusion and 7 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 7 Aug 2018. 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?
Average number of steps. Wearable sensor based (time frame: 5 weeks). 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 NCT03212079, 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 7 Aug 2018.