NCT07463547

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable cancer

Timeline
9mo left

Started Apr 2026

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Apr 2026Feb 2027

First Submitted

Initial submission to the registry

March 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 17, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

March 5, 2026

Last Update Submit

April 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility thresholds for uptake and compliance

    % of eligible patients agree to wearable use and % adherence

    6 months

Study Arms (1)

Patient Group - Wearable

EXPERIMENTAL

Patients are given a wearable to use which tracks physiological health metrics (e.g., sleep, activity, heart rate variability)

Other: Wearable

Interventions

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.

Patient Group - Wearable

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Gabrielle Rocque, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, Division of Hematology & Oncology; Division of Gerontology, Geriatrics, & Palliative Care

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 11, 2026

Study Start

April 17, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations