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| ID | Type | Description | Link |
|---|---|---|---|
| LCI-SUPP-CRF-WATD-001 | Other Identifier | Atrium Health | |
| NCI-2024-06147 | Other Identifier | National Cancer Institute |
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| Name | Class |
|---|---|
| Atrium Health Levine Cancer Institute | OTHER |
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The purpose of this study is to evaluate the feasibility of using a commercial WATD (Wearable Activity Tracker Device) to collect HRV (Heart Rate Variability) data from pancreatic and breast cancer patients.
This feasibility study is designed to evaluate the collection of longitudinal HRV (Heart Rate Variability) data and assess acceptability of the device among adult cancer patients in the research setting. Over the course of the four-week study, participants will be asked to provide experiential diaries detailing adherence to and acceptability of the WATD (Wearable Activity Tracker Device) and conduct PRO (Patient Reported Outcome) measures at week two and week four (end of study). During the final research visit at week four, subjects will return the WATD and will complete the acceptability survey. Each week of the four-week study, the WATD data and experiential diaries will be downloaded for analysis.
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| Measure | Description | Time Frame |
|---|---|---|
| Adherence and acceptability | Adherence is a binary variable and will be determined based on whether the participant uploads HRV data each morning at least 75% of the days during the 14-day trial. Acceptability is a binary variable, and it is based on participant's response to the question whether they find the Wearable Activity Tracker Device (WATD) easy to use in the acceptability survey. | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Theme | Themes are categories of consolidated meaning derived from qualitative data that concern acceptability and adherence to using the Wearable Activity Tracker Device (WATD). They are derived based on qualitative analysis of the Experiential Diary, Acceptability survey open-ended data, and lifestyle behavior data. Theme is a categorical variable. | Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients ≥ 18 years of age who have any stage pancreatic or breast cancer per enrolling investigator and have self-reported fatigue
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maggie Dzhanumova | Contact | 704-754-3768 | margarita.dzhanumova@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Dori Beeler, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Heart rate variability (HRV) | HRV is the variation in the time intervals between adjacent heartbeats. It is a continuous variable and is measured by the Wearable Activity Tracker Device (WATD). | Day 14 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |