NCT05391217

Feasibility of Remote Activity Assessment and PRO Collection Among Transgender Cancer Survivors

Study to Remotely Monitor Activity in Transgender Cancer Survivors

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Prospective observational feasibility study to evaluate the role of wearable activity monitors to determine the feasibility and acceptability of remote monitoring using wearable technology and PROs to monitor fatigue and physical function in transgender cancer patients and survivors.

Detailed description

Transgender cancer survivors are a diverse population who currently suffer from cancer-related disparities. Enrolled subjects will receive wearable activity devices to help understand how their daily activity (e.g., daily step counts, stairs climbed) and sleep levels are affected by their symptoms and treatment side-effects, including fatigue, physical functioning, emotional well-being, sleep quality, and quality of life over the 2-week course of the study. Qualitative interviews will be conducted to gain a deeper understanding of barriers to physical activity and their perceived relationships with their cancer history, treatment symptoms and gender affirming hormone therapy.

Conditions

• Neoplasms
• Chronic Disease

Interventions

Type	Name	Description
OTHER	Remote assessment of patient reported outcomes and daily activity	Electronic patient-reported outcomes (NIH PROMIS) will be collected and combined with remotely monitored physical activity, heart rate, and sleep, as measured with a Fitbit (Sense).

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-05-25
• Last updated: 2024-08-27

Locations

1 site across 1 country: United States