Wearable Integration in Symptom Evaluation for Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wearable.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Implementation and Impact of Navigator-Delivered ePRO Home Symptom Monitoring and Management - Wearable Integration in Symptom Evaluation for Cancer Survivors
Overview
The objective of this work is the production of actionable insights that can be leveraged to improve remote symptom monitoring (RSM) in varied practice settings, which in turn, is expected to improve timely, efficient, and high-quality comprehensive care in oncology. Aim 1: To assess the feasibility of incorporating a wearable into an RSM program for patients receiving cancer treatment. Aim 2: To assess the relationship between the wearable and ePRO-reported physical symptoms and functional status. Aim 3: To characterize barriers and facilitators of using the wearable in the RSM program and suggest approaches to incorporating relevant evidence-based interventions.
Detailed description
Remote symptom monitoring (RSM) using electronic patient-reported outcomes (ePROs) benefits patients with cancer on active treatment (i.e., improved symptom assessment efficiency, patient-clinician communication and satisfaction, symptom control and well-being, overall survival). Despite promising RSM results, low sustained adherence and the limited amount of symptom information that can be feasibly captured through surveys limit RSM benefits. Passive data collection through wearable technology may strengthen RSM benefits by providing a more complete and continuous picture of patient health, without substantial patient and system burden. For this investigation, we leverage our existing RSM infrastructure to test the integration of a wearable for enhanced monitoring.
Interventions
- Other Wearable
Patient participants are provided with an industry-leading wearable with multiple research-grade sensors that measure physiological indicators such as temperature, HRV, sleep, and physical activity, with high accuracy.
Primary outcome measures
- Feasibility thresholds for uptake and compliance [Time frame: 6 months]
Eligibility criteria
Inclusion criteria: (1) ≥18 years of age; (2) diagnosed with cancer; (3) enrolled in the ePRO RSM program at O'Neal CCC; (4) uses a smart phone compatible with the wearable.
Exclusion criteria: (1) Lack of English fluency and literacy; (2) Medical condition that makes the person unable to participate, at PI discretion.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT07463547 · IRB-300007406-2