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* 10 patients will be enrolled in stage 1 to refine the HOPE App intervention
* All participants will receive :

  * HOPE App
  * The Fitbit Zip
  * The Fitbit Charge 2 The amount of step collected by each device will be compared. This will allow the team to identify which wearable accelerometer to use in stage 2

Stage 2 will consist of arm 2-5 and will enroll 100 randomized patients.

* Usual care
* The app will also collect passive data from the smartphone

* Participants will be asked to wear the Fitbit
* The Hope App will measure daily steps
* The app will also collect passive data from the smartphone

* Participants will be prompted to answer questions about their quality of life and physical health daily
* The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.
* The app will also collect passive data from the smartphone

* Participants will be prompted to answer questions about their quality of life and physical health daily
* The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.

Participants will be asked to wear the Fitbit

-The Hope App will measure daily steps The app will also collect passive data from the smartphone

* Two smartphone apps and a wearable accelerometer (Fitbit) in 30 patients with gynecologic cancers receiving chemotherapy at two NCI Community Oncology sites.
* The SMART intervention refers to the combination of both smartphone apps (SMART app and Beiwe app) and the accelerometer (Fitbit).
* The SMART app is the technology that is actively collecting symptom reporting information from patients (e.g. patients are receiving surveys, recording their symptoms daily, and receiving tailored symptom management materials on their phone in response).
* The Beiwe app is the technology involved in the passive data collection of participants' symptoms (GPS and accelerometer data) without their involvement.

Fitbit Zip

HOPE App

Standard of Care

Fitbit Charge 2

SMART study app + Beiwe study app + Fitbit

SMART Study Intervention

Alexi A Wright, MD MPH

This research study is evaluating a new smartphone application named the "Helping Our Patients Excel (HOPE)" app with a Fitbit device. The SMART Study is a sub-study of the HOPE Trial. Both studies evaluate an almost identical intervention using a Fitbit device and smartphone app(s) with the goal of improving quality-of-life for women with gynecologic cancers.

The HOPE Trial:

The first goal of this study is to adapt and refine an existing smartphone app, paired with a wearable accelerometer, to assess patients' symptoms in a population of patients with gynecologic cancers receiving palliative chemotherapy. An existing app will be customized to collect patient-reported toxicities using the Patient-Reported Outcome (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and offer patients feedback about how to manage their symptoms. Patient symptoms will be risk-stratified. Patients with low-risk toxicities (grades 1 \& 2) will receive tailored educational information, while patients with serious toxicities (grades 3 \& 4) will receive alerts to call their clinician. In the first phase of the study, we will conduct an initial assessment of the app with a diverse group of 10 patients to refine the app and test two different wearable accelerometers (i.e. Fitbit Zip and Fitbit Charge 2) before pilot testing.

The second goal of this study is to conduct a pilot randomized controlled trial (RCT) of the smartphone app and/or wearable accelerometer (i.e. Fitbit Zip or Fitbit Charge 2) to assess the feasibility, acceptability, and preliminary efficacy of our intervention. During the second phase of the study, we will conduct a 4-arm pilot RCT in 100 patients with gynecologic cancers receiving palliative chemotherapy to establish preliminary effect sizes. Participants will be randomized to: 1) Fitbit+active app, 2) Fitbit+passive app, 3) Active app, or 4) Passive app.

We expect that the results of this pilot RCT, which is supported by the National Cancer Institute, National Palliative Care Research Center, and the Dana-Farber Cancer Institute Department of Medical Oncology, will provide a low-cost, scalable system to assess patients' symptoms, address low-risk toxicities, and alert clinicians when patients have toxicities that require intervention with the goal of reducing patient suffering and the use of high-intensity, hospital-based health care.

The SMART Study:

The overall goals of this study are to test the combination of two smartphone research platforms and a wearable accelerometer for use in NCI Community Oncology Research Program (NCORP) sites to improve cancer patients' quality of life and symptom management. The SMART Study (Symptom Management and Reporting Toxicities) has a single-arm research design and aims to assess the feasibility, acceptability, and perceived efficacy of a wearable accelerometer and two smartphone apps in 30 patients receiving chemotherapy to treat recurrent gynecologic cancers.

The HOPE Trial and the SMART Study

The HOPE Trial: Helping Our Patients Excel, and The SMART Study: Symptom Management and Reporting

This outcome was limited to the HOPE pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites.

Feasibility defined as (1) greater than or equal to 60% enrollment rate among eligible patients approached, (2) greater than or equal to 70% adherence to daily smartphone surveys, (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week. Acceptability defined as responses to 3 questions: (1) "Participating in this study placed a substantial burden on me." (2) "I wish I had not agreed to participate in this study." and (3) "I would recommend the application to a friend going through treatment."

This outcome was limited to the HOPE Pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites.

This outcome is participant preference of the Fitbit Zip vs. Fitbit Charge in the HOPE Pre-Pilot study.

SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.

Feasibility will be defined as greater than or equal to 50% 3-month adherence rates to both smartphone apps and the wearable accelerometer.

SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.

Acceptability defined as responses to three questions: (1) "Participating in this study placed a substantial burden on me."; (2) "I wish I had not agreed to participate in this study."; and (3) "I would recommend the application to a friend going through treatment."

Patients' GAD-7 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.

Patients' PHQ-9 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.

Patients' FACT-O measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.

Patients' PRO-CTCAE measurements (reported by patients) taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.

Patients' and their physicians' ECOG-PS measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.

National Institute of Nursing Research (NINR)

Dana-Farber Cancer Institute

Alexi. A Wright, MD, MPH

10 patients will be enrolled in stage 1 to refine the HOPE App intervention; All participants will receive: HOPE App, The Fitbit Zip, The Fitbit Charge 2

The amount of step collected by each device will be compared. This will allow the team to identify which wearable accelerometer to use in stage 2.

Fitbit Zip: Fitbit Zip HOPE App: HOPE App Fitbit Charge 2: Fitbit Charge 2

HOPE Pre-Pilot

Participants received the Fitbit Charge 2 and access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.

Refined Smartphone App and Accelerometer (HOPE)

Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.

Wearable Accelerometer (HOPE)

Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.

Refined Smartphone App (HOPE)

The HOPE app will collect passive data from the smartphone.

Usual Care (HOPE)

Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.

SMART Study Arm

* 10 patients will be enrolled in stage 1 to refine the HOPE App intervention
* All participants will receive :

  * HOPE App
  * The Fitbit Zip
  * The Fitbit Charge 2 The amount of step collected by each device will be compared. This will allow the team to identify which wearable accelerometer to use in stage 2

Fitbit Zip: Fitbit Zip

HOPE App: HOPE App

Fitbit Charge 2: Fitbit Charge 2

Comparing Steps Collected by Accelerometer (HOPE)

* Participants will be prompted to answer questions about their quality of life and physical health daily
* The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.

Participants will be asked to wear the Fitbit

-The Hope App will measure daily steps The app will also collect passive data from the smartphone

HOPE App: HOPE App

* Participants will be asked to wear the Fitbit
* The Hope App will measure daily steps
* The app will also collect passive data from the smartphone

HOPE App: HOPE App

Fitbit Charge 2: Fitbit Charge 2

* Participants will be prompted to answer questions about their quality of life and physical health daily
* The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.
* The app will also collect passive data from the smartphone

HOPE App: HOPE App

Stage 2 will consist of arm 2-5 and will enroll 100 randomized patients.

* Usual care
* The app will also collect passive data from the smartphone

HOPE App: HOPE App

Standard of Care: Standard of Care

* Two smartphone apps and a wearable accelerometer (Fitbit) in 30 patients with gynecologic cancers receiving chemotherapy at two NCI Community Oncology sites.
* The SMART intervention refers to the combination of both smartphone apps (SMART app and Beiwe app) and the accelerometer (Fitbit).
* The SMART app is the technology that is actively collecting symptom reporting information from patients (e.g. patients are receiving surveys, recording their symptoms daily, and receiving tailored symptom management materials on their phone in response).
* The Beiwe app is the technology involved in the passive data collection of participants' symptoms (GPS and accelerometer data) without their involvement.

SMART Study Intervention: SMART study app + Beiwe study app + Fitbit

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Married

Divorced/Separated

Never Married

Widowed

Missing

Marital Status

Race

Last grade level completed

Dr. Alexi Wright

Feasibility - (1) greater than or equal to 60% enrollment rate among eligible patients approached

Feasibility - (2) greater than or equal to 70% adherence to daily smartphone surveys

Feasibility - (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week

Acceptability - (1) "Participating in this study placed a substantial burden on me."

Acceptability - (2) "I wish I had not agreed to participate in this study."

10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.

HOPE Pre-pilot

Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10)

Preferred FitBit Charge

Preferred FitBit Zip

This outcome was limited to the HOPE pilot, consisting of 10 patients.

Number of Participants Who Preferred the FitBit Zip vs. Number of Participants Who Preferred the FitBit Charge HR in the HOPE Pre-Pilot Study (n=10)

Single arm pre-pilot feasibility and acceptability testing of SMART at University of New Mexico and Sanford Health (Sioux Falls, South Dakota).

SMART Study

Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART Study

Acceptability - (3) "I would recommend the application to a friend going through treatment."

Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and <30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study

Anxiety as Assessed by GAD-7 (HOPE RCT)

Depression as Assessed by PHQ-9 (HOPE RCT)

Patient Well-being as Assessed by FACT-O (HOPE RCT)

Patient Symptoms (Reported by Patients) as Assessed by PRO-CTCAE (HOPE RCT)

Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT)

Participants received the FitBit Charge 2 and access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.

Spots Global Cancer Trial Database for smart study intervention