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NCT05391217RecruitingAccepts Healthy Volunteers

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

Cedars-Sinai Medical Center

Start Date

2/1/2023

Completion Date

7/1/2025

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Self-identifies as transgender person with a history of cancer or receiving treatment for cancer in the last five years from screening for the current study (case) OR self-identifies as transgender person without a history of cancer (control) * 18 years or older * Ambulatory (use of walking aids, such as cane and rollator, is acceptable) * Access to a device (e.g., smartphone, tablet, iPhone) that has the capability to sync to the Fitbit * Have an understanding, ability, and willingness to fully comply with study procedures and restrictions * Can read and understand English, Spanish, or Tagalog (for participant surveys and interviews) * Informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Any person that does not meet the listed criteria above * Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment\*. However, removable hearing aids are permitted.

Interventions

OTHER

Remote assessment of patient reported outcomes and daily activity

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Conditions

NeoplasmsChronic Disease

Locations

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States