NCT03212079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

April 4, 2017

Last Update Submit

August 6, 2018

Conditions

Keywords

Cancer SurvivorsPhysical ActivitiesBaltimoreState of Maryland

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 weeks

Secondary Outcomes (3)

  • Total number and duration of activity bouts. Wearable sensor based

    5 weeks

  • Transitions between active/inactive periods. Wearable sensor based

    5 weeks

  • Daily patterns of activity. Wearable sensor based

    5 weeks

Study Arms (3)

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

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

Behavioral: MyCoach on Amazon Alexa

Interventions

Personalized text messages to you cellphone to help you become more active

Also known as: Smart text
Mycoach Smart Text

This is an intelligent voice that you can communicate with via Amazon echo speaker

Also known as: Digital Voice Assist
MyCoach via Amazon Alexa

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Breast NeoplasmsProstatic NeoplasmsLung NeoplasmsColorectal NeoplasmsUterine Cervical NeoplasmsMouth NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsHead and Neck NeoplasmsMouth DiseasesStomatognathic DiseasesBehavior

Study Officials

  • Ahmed Hassoon, MD,MPH,PMP

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This is a single center three arms randomized trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

July 11, 2017

Study Start

April 3, 2017

Primary Completion

March 15, 2018

Study Completion

June 30, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations