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Trial record 85 of 7039 for:    Oral Cancer | ( Map: United States )

Physical Activities by Technology Help (PATH) (PATH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Prostate Cancer Lung Cancer Colorectal Cancer Cervical Cancer Oral Cancer Behavioral: Mycoach Smart Text Behavioral: MyCoach on Amazon Alexa Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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
Official Title: Novel Individualized Intervention for Behavioral Change Among High-Risk Group Cancer Survivors : Physical Activities by Technology Help (PATH)
Actual Study Start Date : April 3, 2017
Actual Primary Completion Date : March 15, 2018
Actual Study Completion Date : June 30, 2018


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 Name: 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 Name: Digital Voice Assist




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212079


Locations
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United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Ahmed Hassoon, MD,MPH,PMP Johns Hopkins Bloomberg School of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03212079     History of Changes
Other Study ID Numbers: IRB00113882
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Cancer Survivors
Physical Activities
Baltimore
State of Maryland

Additional relevant MeSH terms:
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Colorectal Neoplasms
Uterine Cervical Neoplasms
Mouth Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Head and Neck Neoplasms
Mouth Diseases
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Stomatognathic Diseases