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

Neoplasms Clinical Trial

— STRIDE  

Official title:

Study to Remotely Monitor Activity in Transgender Cancer Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05391217
• Other study ID #: STUDY00001826
• Status: Active, not recruiting
• Start date: February 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2022
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Neoplasms

Intervention

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).

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Average daily step count (steps/day)	Average daily step count over the study period will be calculated from wearable activity monitor	2 weeks
Secondary	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
Secondary	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
Secondary	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