Clinical trial NCT05391217: Feasibility of Remote Activity Assessment and PRO Collection Among Transgender Cancer Survivors
Official title: Study to Remotely Monitor Activity in Transgender Cancer Survivors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasms
Chronic Disease
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of Remote Activity Assessment and PRO Collection
timeFrame: 2 weeks
Secondary outcomes:
measure: Key themes and concepts surrounding the relationships patients have with their treatment symptoms and how they affect their daily activity
timeFrame: 2 weeks
measure: Average daily step count (steps/day)
timeFrame: 2 weeks
measure: 24-Hour Movement
timeFrame: 2 weeks
measure: Patient-reported health and well-being
timeFrame: 2 weeks
measure: Patient-reported mood
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Gillian Gresham, PhD
role: PRINCIPAL_INVESTIGATOR
References: