CancerDigiSTEPSNCT03757182
Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients
An observational study of Cancer and Cancer, Metastatic, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the relationships between objectively measured physical activity and provider-assessed and patient-reported functional outcomes in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer, Metastatic, Neoplasms
- What is being tested?
- Wearable activity monitor
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2018to 31 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Stage 3/4 advanced cancer patients being seen for treatment at Cedars-Sinai Medical Center.
Who may be able to join
- Diagnosis of advanced (stage 3 or 4) cancer of any type
- Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
- Access to a device that has the capability to sync to the Fitbit
- Expected to have standard of care oncology appointments at least once every 8 weeks (+/-7 days).
- Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
- English or Spanish speaking
- Ability to consent
- Informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Who cannot join
- Allergy to surgical steel or elastomer/rubber
- 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
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients: A Single Cohort, Prospective Trial
The purpose of this study is to examine the relationships between objectively measured physical activity and provider-assessed and patient-reported functional outcomes in patients with advanced cancer. Findings from this study will help us better understand how change in daily physical activity, as measured using the wearable activity monitor, is related to change in a patient's functional status and clinical condition.
Read the detailed description
Patients diagnosed with stage 3/ 4 cancer will be enrolled. After providing informed consent, patients will be asked to wear a FitBit Charge HR continuously for 8 weeks with the option to continue wearing the monitor for up to a year after end-of-study. Baseline assessments include a physical exam, medical history, and frailty assessment. The attending oncologist will rate the patient's performance status (ECOG PS) at baseline and 8-weeks follow-up. Patient-reported outcomes (self-reported physical function, fatigue, sleep, emotional distress) will be assessed weekly using NIH PROMIS from baseline up to 8 weeks from end-of-study. They will also be collected at 1 year follow-up. Wearable activity monitor data will be summarized each week for 8 weeks, and then again at 1 year follow-up. Physical activity data (number of steps, stairs climbed, active minutes, heart rate, and sleep duration) will be collected and analyzed at end-of-study (up to 1 year from end-of-study). Overall survival will also be assessed up to 1 year from end-of-study. Absolute change in physical activity levels will be correlated with change in performance status and occurrence of AEs and death to better understand the role of remote activity monitoring in cancer patients.
- Conditions
- Cancer, Cancer, Metastatic, Neoplasms
- Being tested
- Wearable activity monitor
- Keywords
- Wearable device, Fitness tracker, Wearable activity monitor, Biosensor, Performance Status, Activity Monitoring
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable activity monitorOther
Also called Fitness tracker, Wearable device, Biosensor
Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR)
| Study group | Role | What they receive |
|---|---|---|
| Wearable activity monitor | Continuous activity monitoring with Fitbit Charge HR from baseline to up to 1 year from end-of-study. Receives: Other: Wearable activity monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in average step counts at 8 weeks from baseline
Change will be calculated based on difference in average weekly step count at baseline from the average weekly step count at end-of-study visit
Measured: 8 weeks
Absolute change in provider-assessed ECOG Performance Status at 8 weeks from baseline
Change in performance status will be calculated based on difference in provider-assessed Eastern Cooperative Oncology Group (ECOG) performance status at end-of-study visit and baseline ECOG. ECOG Performance Status is rated based on a 5-point scale where a score of 0 indicates best performance status and 5 indicates death. Only one rating of ECOG PS by provider is completed at each timepoint.
Measured: 8 weeks
Secondary outcomes (6)
Absolute change in patient-reported physical function at 8 weeks from baseline
Physical function will be assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) short form, which includes 20 items and a range of 1 (low physical function) to 5 (high physical function). The total score will be calculated and converted into a standardized t-score will be calculated based on a standard cancer population with a mean of 50 and SD of 10.
Measured: 8 weeks
Patient weekly distress levels up to 8 weeks from baseline
Distress will be measured using using NIH Patient-Reported Outcomes Measurement Information System (PROMIS), which includes short forms: emotional distress, sleep quality, pain, and fatigue. Items range from 1 (worse outcome) and 5 (best outcome) where a total score will be calculated and converted into standardized t-scores.
Measured: 8 weeks
Adherence to wearing the device for the specified study period
A patient is considered adherent if they wear the device at least 10 hours per day for at least 4 of 7 days prior to each study timepoint
Measured: 8 weeks
Change in frailty status from baseline to end-of-study visit (up to 8 weeks from baseline)
Score calculated based on total number of frailty characteristics present using Fried's validated Frailty index. Characteristics of frailty include shrinking (weight loss), weakness (grip strength), poor endurance, exhaustion, slowness, and low activity. The minimal score is 0, indicating absence of frailty, and the highest is 5. Frailty index categories include absence of frailty (score of 0), pre-frail or intermediate frail (1-2 criteria) and frail (>3 criteria present).
Measured: 8 weeks
Occurrence of grade 3 or 4 SOC cancer-related adverse events or chemotoxicities and hospitalizations occurring from baseline up to 12 weeks
AEs will be rated using CTCAE v5
Measured: up to 12 weeks
Overall survival up to 1 year from end-of-study
Occurrence of death from any cause
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start5 Dec 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 80 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
- NCT03757182
- Sponsor's protocol ID
- IIT2018-19-GRESH-DIGISTEP
- Acronym
- DigiSTEPS
- Status last verified
- Aug 2024
- First submitted
- 26 Nov 2018
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD available upon request.
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
- Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients: A Single Cohort, Prospective Trial
- ClinicalTrials.gov ID
- NCT03757182
- Acronym / sponsor ID
- DigiSTEPS / IIT2018-19-GRESH-DIGISTEP
- Conditions
- Cancer, Cancer, Metastatic, Neoplasms
- Keywords
- Wearable device, Fitness tracker, Wearable activity monitor, Biosensor, Performance Status, Activity Monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Nov 2018 (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.
The purpose of this study is to examine the relationships between objectively measured physical activity and provider-assessed and patient-reported functional outcomes in patients with advanced cancer. Findings from this study will help us better understand how change in daily physical activity, as measured using the wearable activity monitor, is related to change in a patient's functional status and clinical condition.
Detailed description
Patients diagnosed with stage 3/ 4 cancer will be enrolled. After providing informed consent, patients will be asked to wear a FitBit Charge HR continuously for 8 weeks with the option to continue wearing the monitor for up to a year after end-of-study. Baseline assessments include a physical exam, medical history, and frailty assessment. The attending oncologist will rate the patient's performance status (ECOG PS) at baseline and 8-weeks follow-up. Patient-reported outcomes (self-reported physical function, fatigue, sleep, emotional distress) will be assessed weekly using NIH PROMIS from baseline up to 8 weeks from end-of-study. They will also be collected at 1 year follow-up. Wearable activity monitor data will be summarized each week for 8 weeks, and then again at 1 year follow-up. Physical activity data (number of steps, stairs climbed, active minutes, heart rate, and sleep duration) will be collected and analyzed at end-of-study (up to 1 year from end-of-study). Overall survival will also be assessed up to 1 year from end-of-study. Absolute change in physical activity levels will be correlated with change in performance status and occurrence of AEs and death to better understand the role of remote activity monitoring in cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearable activity monitor | – | Other: Wearable activity monitorContinuous activity monitoring with Fitbit Charge HR from baseline to up to 1 year from end-of-study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage 3/4 advanced cancer patients being seen for treatment at Cedars-Sinai Medical Center.
Key inclusion criteria (8 listed)
- Diagnosis of advanced (stage 3 or 4) cancer of any type
- Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
- Access to a device that has the capability to sync to the Fitbit
- Expected to have standard of care oncology appointments at least once every 8 weeks (+/-7 days).
- Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
Key exclusion criteria (2 listed)
- Allergy to surgical steel or elastomer/rubber
- 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 |
|---|---|---|
| Wearable activity monitorAlso: Fitness tracker, Wearable device, BiosensorContinuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR) | Other | Wearable activity monitor |
Primary outcome
Absolute change in average step counts at 8 weeks from baseline
Time frame: 8 weeks
Change will be calculated based on difference in average weekly step count at baseline from the average weekly step count at end-of-study visit
Absolute change in provider-assessed ECOG Performance Status at 8 weeks from baseline
Time frame: 8 weeks
Change in performance status will be calculated based on difference in provider-assessed Eastern Cooperative Oncology Group (ECOG) performance status at end-of-study visit and baseline ECOG. ECOG Performance Status is rated based on a 5-point scale where a score of 0 indicates best performance status and 5 indicates death. Only one rating of ECOG PS by provider is completed at each timepoint.
6 secondary outcomes
Absolute change in patient-reported physical function at 8 weeks from baseline
Time frame: 8 weeks
Patient weekly distress levels up to 8 weeks from baseline
Time frame: 8 weeks
Adherence to wearing the device for the specified study period
Time frame: 8 weeks
Change in frailty status from baseline to end-of-study visit (up to 8 weeks from baseline)
Time frame: 8 weeks
Occurrence of grade 3 or 4 SOC cancer-related adverse events or chemotoxicities and hospitalizations occurring from baseline up to 12 weeks
Time frame: up to 12 weeks
Overall survival up to 1 year from end-of-study
Time frame: up to 1 year
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: Undecided. IPD available upon request.
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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 Cancer and Cancer, Metastatic, 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 8 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in average step counts at 8 weeks from baseline (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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.