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

Study to Remotely Monitor Activity in Transgender Cancer Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Chronic Disease
• Intervention / Treatment: Other: Remote assessment of patient reported outcomes and daily activity

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Gillian Gresham; Phone Number: 310-423-3341; Email: gillian.gresham@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Katie Barnhill, BS; Phone Number: 310-423-3341; Email: katherine.barnhill@cshs.org
      • Sub-Investigator: Robert Haile, DrPH
      • Sub-Investigator: Zulfikarali Surani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Gillian Gresham, PhD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: STUDY00001826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small feasibility trial with only 20 people from an underrepresented, minority population, thus important to maintain privacy and confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No