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

Cedars-Sinai Medical Center logo

Cedars-Sinai Medical Center

Status

Enrolling

Conditions

Chronic Disease
Neoplasms

Treatments

Other: Remote assessment of patient reported outcomes and daily activity

Study type

Observational

Funder types

Other

Identifiers

NCT05391217
STUDY00001826

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

20 participants in 2 patient groups

Transgender people with history of cancer
Description:
Self-reported cancer history and/or treatment for cancer within the last 5 years.
Treatment:
Other: Remote assessment of patient reported outcomes and daily activity
Transgender people without history of cancer
Description:
People living with other chronic conditions
Treatment:
Other: Remote assessment of patient reported outcomes and daily activity

Trial contacts and locations

1

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Central trial contact

Gillian Gresham

Data sourced from clinicaltrials.gov

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