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Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients (DigiSTEPS)

30 mars 2022 uppdaterad av: Gillian Gresham, Cedars-Sinai Medical Center

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

80

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Los Angeles, California, Förenta staterna, 90048
        • Rekrytering
        • Cedars-Sinai Medical Center
        • Underutredare:
          • Andrew Hendifar, MD
        • Underutredare:
          • Edwin Posadas, MD
        • Underutredare:
          • Stephen Freedland, PhD
        • Underutredare:
          • BJ Rimel, MD
        • Underutredare:
          • Brennan Spiegel, MD
        • Underutredare:
          • Arash Asher, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

Stage 3/4 advanced cancer patients being seen for treatment at Cedars-Sinai Medical Center.

Beskrivning

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Wearable activity monitor
Continuous activity monitoring with Fitbit Charge HR from baseline to up to 1 year from end-of-study.
Övrig: Wearable activity monitor
Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR)
Andra namn:
  • Fitness tracker
  • Wearable device
  • Biosensor

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Absolute change in average step counts at 8 weeks from baseline
Tidsram: 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
8 weeks
Absolute change in provider-assessed ECOG Performance Status at 8 weeks from baseline
Tidsram: 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.
8 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Absolute change in patient-reported physical function at 8 weeks from baseline
Tidsram: 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.
8 weeks
Patient weekly distress levels up to 8 weeks from baseline
Tidsram: 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.
8 weeks
Adherence to wearing the device for the specified study period
Tidsram: 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
8 weeks
Change in frailty status from baseline to end-of-study visit (up to 8 weeks from baseline)
Tidsram: 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).
8 weeks
Occurrence of grade 3 or 4 SOC cancer-related adverse events or chemotoxicities and hospitalizations occurring from baseline up to 12 weeks
Tidsram: up to 12 weeks
AEs will be rated using CTCAE v5
up to 12 weeks
Overall survival up to 1 year from end-of-study
Tidsram: up to 1 year
Occurrence of death from any cause
up to 1 year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Cedars-Sinai Medical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 december 2018

Primärt slutförande (Förväntat)

31 december 2022

Avslutad studie (Förväntat)

31 december 2022

Studieregistreringsdatum

Först inskickad

26 november 2018

Först inskickad som uppfyllde QC-kriterierna

27 november 2018

Första postat (Faktisk)

28 november 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

31 mars 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 mars 2022

Senast verifierad

1 mars 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • IIT2018-19-GRESH-DIGISTEP

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Obeslutsam

IPD-planbeskrivning

IPD available upon request.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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