Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Location status: Recruiting
Location contact
Katie Barnhill, BS
CONTACT
Robert Haile, DrPH
SUB_INVESTIGATOR
Zulfikarali Surani
SUB_INVESTIGATOR
NCT Number: NCT05391217
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Los Angeles, California, 90048, United States
Location status: Recruiting
Katie Barnhill, BS
CONTACT
Robert Haile, DrPH
SUB_INVESTIGATOR
Zulfikarali Surani
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: 2 weeks
Qualitative outcome, as obtained through semi-structured interviews
Time frame: 2 weeks
Average daily step count over the study period will be calculated from wearable activity monitor
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.
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
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.
Contact information is provided by the study sponsor or research team.
Cedars-Sinai Medical Center
Other
Study to Remotely Monitor Activity in Transgender Cancer Survivors
Acronym: STRIDE
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.
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