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Physical Activities by Technology Help (PATH) (PATH)

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ClinicalTrials.gov Identifier: NCT03212079
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE April 4, 2017
First Posted Date  ICMJE July 11, 2017
Last Update Posted Date August 7, 2018
Actual Study Start Date  ICMJE April 3, 2017
Actual Primary Completion Date March 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
Average number of steps. Wearable sensor based [ Time Frame: 5 weeks ]
We will measure your physical activity by number of steps before and after intervention via wearable activity tracker.
Change History Complete list of historical versions of study NCT03212079 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
  • Total number and duration of activity bouts. Wearable sensor based [ Time Frame: 5 weeks ]
    Defined as 3 min. or more of uninterrupted activity measured by wearable sensor.
  • Transitions between active/inactive periods. Wearable sensor based [ Time Frame: 5 weeks ]
    Time spent walking vs time spent sitting measured by all in one sensor.
  • Daily patterns of activity. Wearable sensor based [ Time Frame: 5 weeks ]
    Distribution parameter of number of steps per/minute within 24 hours period. Measured by all in one sensor.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical Activities by Technology Help (PATH)
Official Title  ICMJE Novel Individualized Intervention for Behavioral Change Among High-Risk Group Cancer Survivors : Physical Activities by Technology Help (PATH)
Brief 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. 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:

  1. Group one will be self-motivated to be physically active (control group)
  2. The second group will receive smart daily text messages only (text group);
  3. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a single center three arms randomized trial.
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Breast Cancer
  • Prostate Cancer
  • Lung Cancer
  • Colorectal Cancer
  • Cervical Cancer
  • Oral Cancer
Intervention  ICMJE
  • Behavioral: Mycoach Smart Text
    Personalized text messages to you cellphone to help you become more active
    Other Name: Smart text
  • Behavioral: MyCoach on Amazon Alexa
    This is an intelligent voice that you can communicate with via Amazon echo speaker
    Other Name: Digital Voice Assist
Study Arms  ICMJE
  • No Intervention: Control
    The participant will self motivate hi/herself to increase physical activities.
  • Experimental: Mycoach Smart Text
    The participant will receive personalized smart text messages to encourage him/her to increase physical activities
    Intervention: Behavioral: Mycoach Smart Text
  • Experimental: MyCoach via Amazon Alexa
    The participant will interact with intelligent coach on Amazon Alexa (a digital voice assist) to help him/her become more active
    Intervention: Behavioral: MyCoach on Amazon Alexa
Publications * Hassoon 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2017)
42
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2018
Actual Primary Completion Date March 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03212079
Other Study ID Numbers  ICMJE IRB00113882
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmed Hassoon, MD,MPH,PMP Johns Hopkins Bloomberg School of Public Health
PRS Account Johns Hopkins University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP