Recruiting

Observational Study

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT05391217

Conditions

Neoplasms

Chronic Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Remote assessment of patient reported outcomes and daily activity

Study Details

Brief 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.

Conditions

Neoplasms

Chronic Disease

Study ID

NCT05391217

Start date

Feb 1, 2023

Status verified date

Aug, 2024

Completion date

Jul 1, 2025

Anticipated

Primary completion date

Jul 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Transgender people with history of cancer

Self-reported cancer history and/or treatment for cancer within the last 5 years.

Transgender people without history of cancer

People living with other chronic conditions

Interventions

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).

Primary outcome measure

  • Feasibility of Remote Activity Assessment and PRO Collection [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Gillian Gresham

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

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Katie Barnhill, BS

310-423-3341katherine.barnhill@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Aug 27, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2024-08-27.