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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Transgender man or woman, or identifies as transgender
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gillian Gresham | Contact | 310-423-3341 | gillian.gresham@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Gillian Gresham, PhD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
This is a small feasibility trial with only 20 people from an underrepresented, minority population, thus important to maintain privacy and confidentiality.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000203 | Activities of Daily Living |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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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 |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |