Physical Activities by Technology Help (PATH) (PATH)

August 6, 2018 updated by: Johns Hopkins University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Bloomberg School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Behavioral: Mycoach Smart Text
Personalized text messages to you cellphone to help you become more active
Other Names:
  • 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
Behavioral: MyCoach on Amazon Alexa
This is an intelligent voice that you can communicate with via Amazon echo speaker
Other Names:
  • Digital Voice Assist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 weeks
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.
5 weeks
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.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Ahmed Hassoon, MD,MPH,PMP, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2017

Primary Completion (Actual)

March 15, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

July 6, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00113882

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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