## Protocol Section
### Identification Module
**NCT ID:** NCT03212079

**Acronym:** PATH

**Brief Title:** Physical Activities by Technology Help (PATH)

**Official Title:** Novel Individualized Intervention for Behavioral Change Among High-Risk Group Cancer Survivors : Physical Activities by Technology Help (PATH)

#### Organization Study ID Info
**ID:** IRB00113882
#### Organization
**Class:** OTHER
**Full Name:** Johns Hopkins University
### Status Module
#### Completion Date
**Date:** 2018-06-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-08-07

**Type:** ACTUAL

**Last Update Submit Date:** 2018-08-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-03-15

**Type:** ACTUAL

#### Start Date
**Date:** 2017-04-03

**Type:** ACTUAL

**Status Verified Date:** 2018-08

#### Study First Post Date
**Date:** 2017-07-11
**Type:** ACTUAL
**Study First Submit Date:** 2017-04-04
**Study First Submit QC Date:** 2017-07-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Johns Hopkins University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Breast Cancer

- Prostate Cancer

- Lung Cancer

- Colorectal Cancer

- Cervical Cancer

- Oral Cancer

**Keywords:**

- Cancer Survivors

- Physical Activities

- Baltimore

- State of Maryland

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This is a single center three arms randomized trial.

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 42

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Label:** Control

**Type:** NO_INTERVENTION

#### Arm Group 2

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

**Intervention Names:**

- Behavioral: Mycoach Smart Text

**Label:** Mycoach Smart Text

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Intervention Names:**

- Behavioral: MyCoach on Amazon Alexa

**Label:** MyCoach via Amazon Alexa

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mycoach Smart Text

**Description:** Personalized text messages to you cellphone to help you become more active

**Name:** Mycoach Smart Text

**Other Names:**

- Smart text

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- MyCoach via Amazon Alexa

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

**Name:** MyCoach on Amazon Alexa

**Other Names:**

- Digital Voice Assist

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The investigators will measure your physical activity by number of steps before and after intervention via wearable activity tracker.

**Measure:** Average number of steps. Wearable sensor based

**Time Frame:** 5 weeks

#### Secondary Outcomes

**Description:** Defined as 3 min. or more of uninterrupted activity measured by wearable sensor.

**Measure:** Total number and duration of activity bouts. Wearable sensor based

**Time Frame:** 5 weeks

**Description:** Time spent walking vs time spent sitting measured by all in one sensor.

**Measure:** Transitions between active/inactive periods. Wearable sensor based

**Time Frame:** 5 weeks

**Description:** Distribution parameter of number of steps per/minute within 24 hours period. Measured by all in one sensor.

**Measure:** Daily patterns of activity. Wearable sensor based

**Time Frame:** 5 weeks

### Eligibility Module

**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.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Baltimore

**Country:** United States

**Facility:** Johns Hopkins Bloomberg School of Public Health

**State:** Maryland

**Zip:** 21205

#### Overall Officials

**Official 1:**

**Affiliation:** Johns Hopkins Bloomberg School of Public Health

**Name:** Ahmed Hassoon, MD,MPH,PMP

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**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.

**PMID:** 34887491

**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.

**PMID:** 29434016

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000006258

- Term: Head and Neck Neoplasms

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5830

- Name: Uterine Cervical Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12022

- Name: Mouth Neoplasms

- Relevance: HIGH

- As Found: Oral Cancer

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4265

- Name: Oral Cancer

- Relevance: HIGH

- As Found: Oral Cancer

- ID: T3466

- Name: Lip and Oral Cavity Cancer

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009062

- Term: Mouth Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
