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RecruitingObservational

Study to Remotely Monitor Activity in Transgender Cancer Survivors

NCT ID: NCT05391217Sponsor: Cedars-Sinai Medical CenterLast updated: 2024-08-27

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.

Arms & interventions

  • OtherRemote 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).

Outcome measures

Primary

  • Feasibility of Remote Activity Assessment and PRO Collection

    Proportion of patients who consent to participate in the research study and complete the baseline fatigue assessment, where a proportion of 50% will be considered feasible.

    Time frame: 2 weeks

Secondary

  • Key themes and concepts surrounding the relationships patients have with their treatment symptoms and how they affect their daily activity

    Time frame: 2 weeks

  • Average daily step count (steps/day)

    Time frame: 2 weeks

  • 24-Hour Movement

    Time frame: 2 weeks

  • Patient-reported health and well-being

    Time frame: 2 weeks

  • Patient-reported mood

    Time frame: up to 2 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes
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.

Study locations (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Recruiting
Katie Barnhill, BS · Contact
310-423-3341katherine.barnhill@cshs.org
Robert Haile, DrPH · Sub Investigator
Zulfikarali Surani · Sub Investigator