Chronic Disease, Neoplasms
Conditions
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.
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.
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).
Sponsors
Cedars-Sinai Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Remote Activity Assessment and PRO Collection | 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
| Measure | Time frame | Description |
|---|---|---|
| Key themes and concepts surrounding the relationships patients have with their treatment symptoms and how they affect their daily activity | 2 weeks | Qualitative outcome, as obtained through semi-structured interviews |
| Average daily step count (steps/day) | 2 weeks | Average daily step count over the study period will be calculated from wearable activity monitor |
| 24-Hour Movement | 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. |
| Patient-reported health and well-being | 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 |
| Patient-reported mood | 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. |
Countries
United States
Contacts
Primary ContactGillian Gresham
Outcome results
None listed