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

Recruiting

• Conditions: Neoplasms; Chronic Disease
• Interventions: Other: Remote assessment of patient reported outcomes and daily activity

• Registration Number: NCT05391217
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Study Timeline

• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-25
• Study Start: 2023-02-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-27
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transgender people with history of cancer	Remote assessment of patient reported outcomes and daily activity	Self-reported cancer history and/or treatment for cancer within the last 5 years.
Transgender people without history of cancer	Remote assessment of patient reported outcomes and daily activity	People living with other chronic conditions

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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
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

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States