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Physical Activities by Technology Help (PATH) (PATH)

Primary Purpose

Breast Cancer, Prostate Cancer, Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mycoach Smart Text
MyCoach on Amazon Alexa
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Cancer Survivors, Physical Activities, Baltimore, State of Maryland

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Bloomberg School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Mycoach Smart Text

MyCoach via Amazon Alexa

Arm Description

The participant will self motivate hi/herself to increase physical activities.

The participant will receive personalized smart text messages to encourage him/her to increase physical activities

The participant will interact with intelligent coach on Amazon Alexa (a digital voice assist) to help him/her become more active

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total number and duration of activity bouts. Wearable sensor based
Defined as 3 min. or more of uninterrupted activity measured by wearable sensor.
Transitions between active/inactive periods. Wearable sensor based
Time spent walking vs time spent sitting measured by all in one sensor.
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.

Full Information

First Posted
April 4, 2017
Last Updated
August 6, 2018
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03212079
Brief Title
Physical Activities by Technology Help (PATH)
Acronym
PATH
Official Title
Novel Individualized Intervention for Behavioral Change Among High-Risk Group Cancer Survivors : Physical Activities by Technology Help (PATH)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
March 15, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Prostate Cancer, Lung Cancer, Colorectal Cancer, Cervical Cancer, Oral Cancer
Keywords
Cancer Survivors, Physical Activities, Baltimore, State of Maryland

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a single center three arms randomized trial.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
The participant will self motivate hi/herself to increase physical activities.
Arm Title
Mycoach Smart Text
Arm Type
Experimental
Arm Description
The participant will receive personalized smart text messages to encourage him/her to increase physical activities
Arm Title
MyCoach via Amazon Alexa
Arm Type
Experimental
Arm Description
The participant will interact with intelligent coach on Amazon Alexa (a digital voice assist) to help him/her become more active
Intervention Type
Behavioral
Intervention Name(s)
Mycoach Smart Text
Other Intervention Name(s)
Smart text
Intervention Description
Personalized text messages to you cellphone to help you become more active
Intervention Type
Behavioral
Intervention Name(s)
MyCoach on Amazon Alexa
Other Intervention Name(s)
Digital Voice Assist
Intervention Description
This is an intelligent voice that you can communicate with via Amazon echo speaker
Primary Outcome Measure Information:
Title
Average number of steps. Wearable sensor based
Description
The investigators will measure your physical activity by number of steps before and after intervention via wearable activity tracker.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Total number and duration of activity bouts. Wearable sensor based
Description
Defined as 3 min. or more of uninterrupted activity measured by wearable sensor.
Time Frame
5 weeks
Title
Transitions between active/inactive periods. Wearable sensor based
Description
Time spent walking vs time spent sitting measured by all in one sensor.
Time Frame
5 weeks
Title
Daily patterns of activity. Wearable sensor based
Description
Distribution parameter of number of steps per/minute within 24 hours period. Measured by all in one sensor.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Hassoon, MD,MPH,PMP
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bloomberg School of Public Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34887491
Citation
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.
Results Reference
derived
PubMed Identifier
29434016
Citation
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.
Results Reference
derived

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Physical Activities by Technology Help (PATH)

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