Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05391217

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Katie Barnhill, BS

CONTACT

[email protected]

310-423-3341

Robert Haile, DrPH

SUB_INVESTIGATOR

Zulfikarali Surani

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote assessment of patient reported outcomes and daily activity

Other

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

Primary outcomes

  1. Feasibility of Remote Activity Assessment and PRO Collection

    Time frame: 2 weeks

    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.

Secondary outcomes

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

    Time frame: 2 weeks

    Qualitative outcome, as obtained through semi-structured interviews

  2. Average daily step count (steps/day)

    Time frame: 2 weeks

    Average daily step count over the study period will be calculated from wearable activity monitor

  3. 24-Hour Movement

    Time frame: 2 weeks

    A composite of average time spent in physical activity (light/moderate/vigorous), time sedentary, and sleep will be calculated following the 24-hour movement continuum guidelines and average values will be obtained over the study period.

  4. Patient-reported health and well-being

    Time frame: 2 weeks

    NIH PROMIS surveys (Likert scale range 0-5, where 5 is the highest level of well-being) at baseline and end of study

  5. Patient-reported mood

    Time frame: up to 2 weeks

    Mean NIH PROMIS anxiety, depression and stress scores (range 0-5), converted to T-scores (mean 50, SD 10) at each timepoints.

Study contacts

Contact information is provided by the study sponsor or research team.

Gillian Gresham

CONTACT

[email protected]

310-423-3341

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Study to Remotely Monitor Activity in Transgender Cancer Survivors

Acronym: STRIDE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 25, 2022
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.