| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Malignant Neoplasm | Device: Activity Monitor Other: Media Intervention | Not Applicable |
PRIMARY OBJECTIVES:
I. To determine if in-office movement trackers identify those patients who are at highest risk for serious adverse events (SAEs) on early and developmental therapeutics (EDT) cancer trials.
SECONDARY OBJECTIVES:
Secondary objectives are related to outpatient activity trackers. I. To determine the association between the occurrence of SAEs and early trial termination, with baseline measurement of activity classification using outpatient activity trackers in the 7 days after screening visit.
II. To determine the association between the occurrence of SAEs and early trial termination, with the change in activity level classification between the week after screening visit and the week after the start of EDT.
III. To determine the association between the occurrence of SAEs and early trial termination, with averaged activity level classification in the first 4 weeks of the EDT.
OUTLINE:
Patients participant in movement assessment during 2 clinical trial visits. Patients also wear a Fitbit to track movements and complete a smartphone based Patient Reported Outcomes (PRO) diary over 5-10 minutes to measure physical function, fatigue, sleep disturbance, social isolation, appetite, and body weight for up to 180 days.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 68 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Precision Performance Status Assessment in Early Phase Clinical Trials |
| Actual Study Start Date : | March 27, 2019 |
| Estimated Primary Completion Date : | March 27, 2022 |
| Estimated Study Completion Date : | March 27, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Prevention (Fitbit, PRO diary)
Patients participant in movement assessment during 2 clinical trial visits. Patients also wear a Fitbit to track movements and complete a smartphone based PRO diary over 5-10 minutes to measure physical function, fatigue, sleep disturbance, social isolation, appetite, and body weight for up to 180 days.
|
Device: Activity Monitor
Wear a Fitbit
Other Name: Activity Tracker; Activity Tracker Device; Physical Activity Measuring Device
Other: Media Intervention Complete smartphone based PRO diary
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| United States, California | |
| Los Angeles County-USC Medical Center | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Aaron E. Mejia 323-409-4355 aaron.mejia@med.usc.edu | |
| Principal Investigator: Jorge J. Nieva | |
| USC / Norris Comprehensive Cancer Center | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Aaron E. Mejia 323-409-4355 aaron.mejia@med.usc.edu | |
| Principal Investigator: Jorge J. Nieva | |
| Hoag Memorial Hospital | Recruiting |
| Newport Beach, California, United States, 92663 | |
| Contact: Cristina de Leon 949-764-5543 cristina.deleon@hoag.org | |
| Principal Investigator: Diana L. Hanna | |
| Principal Investigator: | Jorge J Nieva | University of Southern California |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 29, 2019 | ||||||
| First Posted Date ICMJE | June 3, 2019 | ||||||
| Last Update Posted Date | April 8, 2021 | ||||||
| Actual Study Start Date ICMJE | March 27, 2019 | ||||||
| Estimated Primary Completion Date | March 27, 2022 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Incidence of non-hematologic serious adverse events (SAEs) [ Time Frame: Up to 60 days ] SAEs are the grade 3 or 4 non-hematologic toxicities based on CTCAE 4.0 and documented in each therapeutic clinical trials that participants were treated on. Logistic regression will be used to test the association of average measurements of Get-up and Go, and Kinect assessments collected from screening visit day (visit 1) and the first day of Early and Developmental Therapeutics (EDT) trial (visit 2) with the occurrence of SAEs after EDT given, especially during the first 60 days on EDT trial.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Movement and Fitness Trackers in Determining Performance Status | ||||||
| Official Title ICMJE | Precision Performance Status Assessment in Early Phase Clinical Trials | ||||||
| Brief Summary | This trial studies the use of movement and fitness trackers in determining performance status of patients with cancer who are taking part in early phase clinical. Movement and fitness trackers record movement and a number of different metrics such as steps, heart rate, and calories burned. The use of movement and fitness trackers can provide a more objective and precise estimate of patient performance status and help identify those most at risk for adverse events and hospitalization. | ||||||
| Detailed Description |
PRIMARY OBJECTIVES: I. To determine if in-office movement trackers identify those patients who are at highest risk for serious adverse events (SAEs) on early and developmental therapeutics (EDT) cancer trials. SECONDARY OBJECTIVES: Secondary objectives are related to outpatient activity trackers. I. To determine the association between the occurrence of SAEs and early trial termination, with baseline measurement of activity classification using outpatient activity trackers in the 7 days after screening visit. II. To determine the association between the occurrence of SAEs and early trial termination, with the change in activity level classification between the week after screening visit and the week after the start of EDT. III. To determine the association between the occurrence of SAEs and early trial termination, with averaged activity level classification in the first 4 weeks of the EDT. OUTLINE: Patients participant in movement assessment during 2 clinical trial visits. Patients also wear a Fitbit to track movements and complete a smartphone based Patient Reported Outcomes (PRO) diary over 5-10 minutes to measure physical function, fatigue, sleep disturbance, social isolation, appetite, and body weight for up to 180 days. |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
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| Condition ICMJE | Malignant Neoplasm | ||||||
| Intervention ICMJE |
|
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| Study Arms ICMJE | Experimental: Prevention (Fitbit, PRO diary)
Patients participant in movement assessment during 2 clinical trial visits. Patients also wear a Fitbit to track movements and complete a smartphone based PRO diary over 5-10 minutes to measure physical function, fatigue, sleep disturbance, social isolation, appetite, and body weight for up to 180 days.
Interventions:
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE |
68 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | March 27, 2023 | ||||||
| Estimated Primary Completion Date | March 27, 2022 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | |||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03971266 | ||||||
| Other Study ID Numbers ICMJE | 0S-18-8 NCI-2019-02543 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 0S-18-8 ( Other Identifier: USC / Norris Comprehensive Cancer Center ) P30CA014089 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | University of Southern California | ||||||
| Study Sponsor ICMJE | University of Southern California | ||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||
| Investigators ICMJE |
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| PRS Account | University of Southern California | ||||||
| Verification Date | April 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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