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

Purpose

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.

Conditions

  • Neoplasms
  • Chronic Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy 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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Transgender people with history of cancer Self-reported cancer history and/or treatment for cancer within the last 5 years.
  • 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).
    Other names:
    • PROs + remote physical activity monitoring
Transgender people without history of cancer People living with other chronic conditions
  • 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).
    Other names:
    • PROs + remote physical activity monitoring

Recruiting Locations

Cedars-Sinai Medical Center
Los Angeles, California 90048
Contact:
Katie Barnhill, BS
310-423-3341
katherine.barnhill@cshs.org

More Details

Status
Recruiting
Sponsor
Cedars-Sinai Medical Center

Study Contact

Gillian Gresham
310-423-3341
gillian.gresham@cshs.org

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.