NeoplasmsSTRIDENCT05391217
Feasibility of Remote Activity Assessment and PRO Collection Among Transgender Cancer Survivors
An observational study of Neoplasms and Chronic Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasms, Chronic Disease
- What is being tested?
- Remote assessment of patient reported outcomes and daily activity
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Katie Barnhill, BS, 310-423-3341, katherine.barnhill@cshs.org
Robert Haile, DrPH
About this study
Official title: 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.
Read the 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.
- Conditions
- Neoplasms, Chronic Disease
- Being tested
- Remote assessment of patient reported outcomes and daily activity
- Medical subject headings
- Neoplasms, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote assessment of patient reported outcomes and daily activityOther
Also called PROs + remote physical activity monitoring
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).
| Study group | Role | What they receive |
|---|---|---|
| Transgender people with history of cancer | Self-reported cancer history and/or treatment for cancer within the last 5 years. Receives: Other: Remote assessment of patient reported outcomes and daily activity | |
| Transgender people without history of cancer | People living with other chronic conditions Receives: Other: Remote assessment of patient reported outcomes and daily activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (5)
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
Measured: 2 weeks
Average daily step count (steps/day)
Average daily step count over the study period will be calculated from wearable activity monitor
Measured: 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.
Measured: 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
Measured: 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.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Feb 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gillian Gresham, Cedars-Sinai Medical Center
- Investigators
- Gillian Gresham, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391217
- Sponsor's protocol ID
- STUDY00001826
- Acronym
- STRIDE
- Status last verified
- Aug 2024
- First submitted
- 20 Apr 2022
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small feasibility trial with only 20 people from an underrepresented, minority population, thus important to maintain privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Remotely Monitor Activity in Transgender Cancer Survivors
- ClinicalTrials.gov ID
- NCT05391217
- Acronym / sponsor ID
- STRIDE / STUDY00001826
- Conditions
- Neoplasms, Chronic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transgender people with history of cancer | – | Other: Remote assessment of patient reported outcomes and daily activitySelf-reported cancer history and/or treatment for cancer within the last 5 years. |
| Transgender people without history of cancer | – | Other: Remote assessment of patient reported outcomes and daily activityPeople living with other chronic conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote assessment of patient reported outcomes and daily activityAlso: PROs + remote physical activity monitoringElectronic 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 | Transgender people with history of cancer, Transgender people without history of cancer |
Primary outcome
Feasibility of Remote Activity Assessment and PRO Collection
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.
5 secondary outcomes
Key themes and concepts surrounding the relationships patients have with their treatment symptoms and how they affect their daily activity
Time frame: 2 weeks
Average daily step count (steps/day)
Time frame: 2 weeks
24-Hour Movement
Time frame: 2 weeks
Patient-reported health and well-being
Time frame: 2 weeks
Patient-reported mood
Time frame: up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No. This is a small feasibility trial with only 20 people from an underrepresented, minority population, thus important to maintain privacy and confidentiality.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gillian Gresham, PhD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Chronic Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gillian Gresham (310-423-3341, gillian.gresham@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Remote Activity Assessment and PRO Collection (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.