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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21NR018532 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparing Steps Collected by Accelerometer (HOPE) | Experimental |
|
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| Usual care (HOPE) | Other | Stage 2 will consist of arm 2-5 and will enroll 100 randomized patients.
|
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| Wearable accelerometer (HOPE) | Experimental |
|
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| Refined smartphone app (HOPE) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit Zip | Device | Fitbit Zip |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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." | 30 days |
| 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) | 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. | 30 days |
| Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety as Assessed by GAD-7 (HOPE RCT) | Patients' GAD-7 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. [The General Anxiety Disorder-7 (GAD-7) total score has a minimum value of 0 and a maximum value of 21, with higher values corresponding to worse outcome.}](streamdown:incomplete-link) | Baseline, 30 days, 90 days, 180 days (Phase II) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexi A Wright, MD MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | HOPE Pre-Pilot | 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. |
| FG001 | Refined Smartphone App and Accelerometer (HOPE) | 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. |
| FG002 | Wearable Accelerometer (HOPE) | Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data. |
| FG003 | Refined Smartphone App (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. |
| FG004 | Usual Care (HOPE) | The HOPE app will collect passive data from the smartphone. |
| FG005 | SMART Study Arm | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Comparing Steps Collected by Accelerometer (HOPE) |
Fitbit Zip: Fitbit Zip HOPE App: HOPE App Fitbit Charge 2: Fitbit Charge 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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." | Posted | Count of Participants | Participants | 30 days |
|
HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Only death and serious adverse events were assessed for the SMART Study Arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HOPE Pre-Pilot | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexi Wright | Dana-Farber Cancer Institute | 617-632-2334 | alexi_wright@dfci.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2021 | Mar 3, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Refined smartphone app and accelerometer (HOPE) | Experimental |
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 |
|
| SMART Study Arm | Experimental |
|
|
| HOPE App |
| Other |
HOPE App |
|
| Standard of Care | Other | Standard of Care |
|
| Fitbit Charge 2 | Device | Fitbit Charge 2 |
|
| SMART Study Intervention | Other | SMART study app + Beiwe study app + Fitbit |
|
| 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 | 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." | 90 days |
| Depression as Assessed by PHQ-9 (HOPE RCT) | Patients' PHQ-9 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Patient Health Questionnaire (PHQ-9) total score has a minimum value of 0 and a maximum value of 27, with higher values corresponding to worse outcome.} | Baseline, 30 days, 90 days, 180 days (Phase II) |
| Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | Patients' FACIT-Pal measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) total score has a minimum value of 0 and a maximum value of 184, with higher values corresponding to better outcome.} | Baseline, 30 days, 90 days, 180 days (Phase II) |
| Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 1-3 constipation at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Baseline, 30 days, 90 days, 180 days (Phase II) |
| Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 1-3 diarrhea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Baseline, 30 days, 90 days, 180 days (Phase II) |
| Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 1-3 nausea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Baseline, 30 days, 90 days, 180 days (Phase II) |
| Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 1-3 vomiting at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Baseline, 30 days, 90 days, 180 days (Phase II) |
| Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 1-3 numbness and tingling at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Baseline, 30 days, 90 days, 180 days (Phase II) |
| Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 1-3 dizziness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Baseline, 30 days, 90 days, 180 days (Phase II) |
| Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 1-3 abdominal pain at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Baseline, 30 days, 90 days, 180 days (Phase II) |
| Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 2-3 anxiousness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Baseline, 30 days, 90 days, 180 days (Phase II) |
| Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 2-3 sadness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Baseline, 30 days, 90 days, 180 days (Phase II) |
| Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 2-3 fatigue at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Baseline, 30 days, 90 days, 180 days (Phase II) |
| Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | Patients' and their physicians' ECOG-PS measurements taken at baseline and post-baseline (30 days, 90 days, and 180days) in the HOPE RCT. Weighted Kappa statistics calculated at each timepoint to assess correlation. | Baseline, 30 days, 90 days, 180 days (Phase II) |
| BG001 | Refined Smartphone App and Accelerometer (HOPE) |
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 |
| BG002 | Wearable Accelerometer (HOPE) |
HOPE App: HOPE App Fitbit Charge 2: Fitbit Charge 2 |
| BG003 | Refined Smartphone App (HOPE) |
HOPE App: HOPE App |
| BG004 | Usual Care (HOPE) | Stage 2 will consist of arm 2-5 and will enroll 100 randomized patients.
HOPE App: HOPE App Standard of Care: Standard of Care |
| BG005 | SMART Study Arm |
SMART Study Intervention: SMART study app + Beiwe study app + Fitbit |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Race | Count of Participants | Participants |
|
| Last grade level completed | Count of Participants | Participants |
|
| OG000 | HOPE Pre-pilot | 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. |
|
|
| Primary | 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) | 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. | This outcome was limited to the HOPE pilot, consisting of 10 patients. | Posted | Number | participants | 30 days |
|
|
|
| Primary | Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART 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. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Primary | 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 | 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." | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Anxiety as Assessed by GAD-7 (HOPE RCT) | Patients' GAD-7 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. [The General Anxiety Disorder-7 (GAD-7) total score has a minimum value of 0 and a maximum value of 21, with higher values corresponding to worse outcome.}](streamdown:incomplete-link) | Participants with available data at each time point. | Posted | Mean | Standard Deviation | GAD-7 Total score | Baseline, 30 days, 90 days, 180 days (Phase II) |
|
|
|
| Secondary | Depression as Assessed by PHQ-9 (HOPE RCT) | Patients' PHQ-9 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Patient Health Questionnaire (PHQ-9) total score has a minimum value of 0 and a maximum value of 27, with higher values corresponding to worse outcome.} | Participants with available data at each time point. | Posted | Mean | Standard Deviation | PHQ-9 total score | Baseline, 30 days, 90 days, 180 days (Phase II) |
|
|
|
| Secondary | Patient Well-being as Assessed by FACIT-Pal (HOPE RCT) | Patients' FACIT-Pal measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {The Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) total score has a minimum value of 0 and a maximum value of 184, with higher values corresponding to better outcome.} | Participants with available data at each time point. | Posted | Mean | Standard Deviation | Total score | Baseline, 30 days, 90 days, 180 days (Phase II) |
|
|
|
| Secondary | Constipation as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 1-3 constipation at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Participants with available data at each time point. | Posted | Count of Participants | Participants | Baseline, 30 days, 90 days, 180 days (Phase II) |
|
|
|
| Secondary | Diarrhea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 1-3 diarrhea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Participants with available data at each time point. | Posted | Count of Participants | Participants | Baseline, 30 days, 90 days, 180 days (Phase II) |
|
|
|
| Secondary | Nausea as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 1-3 nausea at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Participants with available data at each time point. | Posted | Count of Participants | Participants | Baseline, 30 days, 90 days, 180 days (Phase II) |
|
|
|
| Secondary | Vomiting as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 1-3 vomiting at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Participants with available data at each time point. | Posted | Count of Participants | Participants | Baseline, 30 days, 90 days, 180 days (Phase II) |
|
|
|
| Secondary | Numbness and Tingling as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 1-3 numbness and tingling at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Participants with available data at each time point. | Posted | Count of Participants | Participants | Baseline, 30 days, 90 days, 180 days (Phase II) |
|
|
|
| Secondary | Dizziness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 1-3 dizziness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Participants with available data at each time point. | Posted | Count of Participants | Participants | Baseline, 30 days, 90 days, 180 days (Phase II) |
|
|
|
| Secondary | Abdominal Pain as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 1-3 abdominal pain at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Participants with available data at each time point. | Posted | Count of Participants | Participants | Baseline, 30 days, 90 days, 180 days (Phase II) |
|
|
|
| Secondary | Anxiousness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 2-3 anxiousness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Participants with available data at each time point. | Posted | Count of Participants | Participants | Baseline, 30 days, 90 days, 180 days (Phase II) |
|
|
|
| Secondary | Sadness as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 2-3 sadness at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Participants with available data at each time point. | Posted | Count of Participants | Participants | Baseline, 30 days, 90 days, 180 days (Phase II) |
|
|
|
| Secondary | Fatigue as Measured by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). | Participants reporting Grade 2-3 fatigue at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT. {Symptoms were graded in accordance with the established composite grading algorithm, with higher grades corresponding to worse outcomes.} | Participants with available data at each time point. | Posted | Count of Participants | Participants | Baseline, 30 days, 90 days, 180 days (Phase II) |
|
|
|
| Secondary | Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT) | Patients' and their physicians' ECOG-PS measurements taken at baseline and post-baseline (30 days, 90 days, and 180days) in the HOPE RCT. Weighted Kappa statistics calculated at each timepoint to assess correlation. | Participants who had both physician- and patient-reported ECOG Performance Status (PS) assessed at baseline and/or follow-up timepoints. | Posted | Number | Weighted Kappa (no unit) | Baseline, 30 days, 90 days, 180 days (Phase II) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | Refined Smartphone App and Accelerometer (HOPE) | 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. | 0 | 23 | 0 | 23 | 22 | 23 |
| EG002 | Wearable Accelerometer (HOPE) | Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data. | 0 | 21 | 0 | 21 | 19 | 21 |
| EG003 | Refined Smartphone App (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. | 0 | 22 | 0 | 22 | 21 | 22 |
| EG004 | Usual Care (HOPE) | The HOPE app will collect passive data from the smartphone. | 2 | 22 | 0 | 22 | 18 | 22 |
| EG005 | SMART Study Arm | 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. | 0 | 4 | 0 | 4 | 0 | 0 |
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomit | Gastrointestinal disorders | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Anxiety | Nervous system disorders | Non-systematic Assessment |
|
| Depression | Nervous system disorders | Non-systematic Assessment |
|
| Fatigue | Nervous system disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
|
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| 30 days post-baseline |
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| 90 days post-baseline |
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| 180 days post-baseline |
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| 30 days post-baseline |
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| 90 days post-baseline |
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| 180 days post-baseline |
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| 30 days post-baseline |
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| 90 days post-baseline |
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| 180 days post-baseline |
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| 30 days post-baseline |
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| 90 days post-baseline |
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| 180 days post-baseline |
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| 30 days post-baseline |
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| 90 days post-baseline |
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| 180 days post-baseline |
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| 30 days post-baseline |
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| 90 days post-baseline |
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| 180 days post-baseline |
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| 30 days post-baseline |
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| 90 days post-baseline |
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| 180 days post-baseline |
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| 30 days post-baseline |
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| 90 days post-baseline |
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| 180 days post-baseline |
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| 30 days post-baseline |
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| 90 days post-baseline |
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| 180 days post-baseline |
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| 30 days post-baseline |
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| 90 days post-baseline |
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| 180 days post-baseline |
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| 30 days post-baseline |
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| 90 days post-baseline |
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| 180 days post-baseline |
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| 30 days post-baseline |
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| 90 days post-baseline |
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| 180 days post-baseline |
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| 30 days post-baseline |
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| 90 days post-baseline |
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| 180 days post-baseline |
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| 30 days post-baseline |
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| 90 days post-baseline |
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| 180 days post-baseline |
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