Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients (DigiSTEPS)
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|ClinicalTrials.gov Identifier: NCT03757182|
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : April 25, 2019
|Condition or disease||Intervention/treatment|
|Cancer Cancer, Metastatic Neoplasms||Other: Wearable activity monitor|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients: A Single Cohort, Prospective Trial|
|Actual Study Start Date :||December 5, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Wearable activity monitor
Continuous activity monitoring with Fitbit Charge HR from baseline to up to 1 year from end-of-study.
Other: Wearable activity monitor
Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR)
- 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.
- Absolute change in patient-reported physical function at 8 weeks from baseline [ Time Frame: 8 weeks ]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.
- Patient weekly distress levels up to 8 weeks from baseline [ Time Frame: 8 weeks ]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.
- Adherence to wearing the device for the specified study period [ Time Frame: 8 weeks ]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
- Change in frailty status from baseline to end-of-study visit (up to 8 weeks from baseline) [ Time Frame: 8 weeks ]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).
- 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 ]AEs will be rated using CTCAE v5
- Overall survival up to 1 year from end-of-study [ Time Frame: up to 1 year ]Occurrence of death from any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757182
|Contact: Gillian Gresham, PhDfirstname.lastname@example.org|
|Contact: Rachel Baynes, MAemail@example.com|
|United States, California|
|Cedars-Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Gillian Gresham 310-423-3341 Gillian.Gresham@cshs.org|
|Principal Investigator: Stephen Freedland, PhD|
|Sub-Investigator: BJ Rimel, MD|
|Sub-Investigator: Brennan Spiegel, MD|
|Sub-Investigator: Jun Gong, MD|
|Sub-Investigator: Arash Asher, MD|
|Sub-Investigator: Andrew Hendifar, MD|
|Sub-Investigator: Christine Walsh, MD|
|Sub-Investigator: Edwin Posadas, MD|
|Principal Investigator:||Stephen Freedland, MD||Cedars-Sinai Medical Center|