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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study to Remotely Monitor Activity in Transgender Cancer Survivors

Conditions
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Neoplasms, Chronic Disease

Intervention / Treatment
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* Other: Remote assessment of patient reported outcomes and daily activity


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transgender people with history of cancer<br>Self-reported cancer history and/or treatment for cancer within the last 5 years. | Other: Remote assessment of patient reported outcomes and daily activity<br>* 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).<br>* Other names: PROs + remote physical activity monitoring;|
| Transgender people without history of cancer<br>People living with other chronic conditions | Other: Remote assessment of patient reported outcomes and daily activity<br>* 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).<br>* Other names: PROs + remote physical activity monitoring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Remote Activity Assessment and PRO Collection | 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. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Key themes and concepts surrounding the relationships patients have with their treatment symptoms and how they affect their daily activity | Qualitative outcome, as obtained through semi-structured interviews | 2 weeks | 
| Average daily step count (steps/day) | Average daily step count over the study period will be calculated from wearable activity monitor | 2 weeks | 
| 24-Hour Movement | 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. | 2 weeks | 
| Patient-reported health and well-being | NIH PROMIS surveys (Likert scale range 0-5, where 5 is the highest level of well-being) at baseline and end of study | 2 weeks | 
| Patient-reported mood | Mean NIH PROMIS anxiety, depression and stress scores (range 0-5), converted to T-scores (mean 50, SD 10) at each timepoints. | up to 2 weeks |