Malignant Solid TumorNCT02844400
Cancer Patients' Performance Status Assessed Using Cardiopulmonary Exercise Testing and Wearable Data Generation
An observational study of Malignant Solid Tumor and Hematologic Malignancies, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The primary objective of this study is to establish the feasibility and value of physical fitness assessment within patients receiving cytotoxic chemotherapy. If successful, this project will establish the groundwork for physical function assessment in larger cancer clinical trials to assist patient selection and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumor, Hematologic Malignancies
- What is being tested?
- Biometric Devices and Physical Performance Testing
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Dec 2018
- 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: 60 patients with cancer undergoing a cycle of cytotoxic chemotherapy.
Who may be able to join
- Patients receiving cytotoxic chemotherapy with at least a 3 week cycle (either adjuvant/curative or palliative)
- Age ≥ 18, prioritizing patients ≥ 60 years
- At least 6 weeks out from surgical resection
- Presence of working email address
- Access to internet at home and either access to wireless internet or cellular data reception
- Ability to read and understand English
- Ability to understand and comply with study procedures
Who cannot join
- Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent
- Contraindication to CPET per standard American Thoracic Society (ATS) guidelines
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
About this study
Official title: Assessing Performance Status in Cancer Patients Using Cardiopulmonary Exercise Testing and Wearable Data Generation: A Prospective Observational Study
The primary objective of this study is to establish the feasibility and value of physical fitness assessment within patients receiving cytotoxic chemotherapy. If successful, this project will establish the groundwork for physical function assessment in larger cancer clinical trials to assist patient selection and evaluation of toxicity and/or response among trial participants.
Read the detailed description
Physical fitness, whether measured by performance capacity or daily activity, can predict risk of toxicity while helping to evaluate toxicity itself in the course of cancer chemotherapy. Cytotoxic chemotherapy causes premature aging and frailty in many cancer patients, so measuring and improving physical function may also limit late morbidity and mortality. Clinician-rated performance status (cPS; e.g., ECOG or Karnofsky PS) with or without concomitant organ function testing is the usual gold standard for risk prognostication and patient selection in most cancer settings, but cPS is subjective, unreliable, and relatively sensitive only for patients with significant functional compromise. Objective evaluations of physical function have the potential to augment or even replace cPS in the cancer treatment setting.
- Conditions
- Malignant Solid Tumor, Hematologic Malignancies
- Being tested
- Biometric Devices, Physical Performance Testing
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biometric DevicesDevice
Patients will wear two devices: HealthPatch Sensor and Phillips Actiwatch. Health data (e.g. average steps per day, resting heart rate) will be collected and monitored over the course of a cycle of cytotoxic chemotherapy.
Physical Performance TestingOther
Patients will complete a CPET and 6 minute walk test within one week of starting an upcoming chemotherapy cycle and they will undergo a second CPET upon completion of said chemotherapy cycle.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant and Curative Chemotherapy | 30 participants. Primarily older (60+ years in age) cancer patients receiving cytotoxic chemotherapy with adjuvant or curative intent. Will undergo both the Physical Performance Testing and Biometric Devices interventions. Receives: Device: Biometric Devices; Other: Physical Performance Testing | |
| Palliative Chemoteraphy | 30 participants. Primarily older (60+ years in age) cancer patients receiving cytotoxic chemotherapy with palliative intent. Will undergo both the Physical Performance Testing and Biometric Devices interventions. Receives: Device: Biometric Devices; Other: Physical Performance Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients being approached that agree to participate in the study
Measure 1 for study feasibility
Measured: 12 months
Proportion of patients who complete both baseline and follow up CPET tests without significant testing-related adverse events
Measure 2 for study feasibility
Measured: 12 months
Proportion of patients who wear HealthPatch and have data captured successfully for at least 75% of the time
Measure 3 for study feasibility
Measured: 12 months
Patients who wear Philips Actiwatch and have data captured successfully for at least 75% of the time
Measure 4 for study feasibility
Measured: 12 months
Proportion of patients for whom all data is successfully recorded within the database
Measure 5 for study feasibility
Measured: 12 months
Secondary outcomes (8)
VO2max measured both pre- and post-chemotherapy
Measured via cycle egometry
Measured: 12 months
6 Minute Walk Distance (6MWD)
Measured: 12 months
Patient-reported sympotomatic toxicity and quality of life
Measured using PROMIS, PRO-CTCAE, Godin Leisure Time Exercise questionnaires and Geriatric Assessment
Measured: 12 months
Patient activity/steps per day
Measured using Philips Actiwatch
Measured: 12 months
Heart rate
Continuous heart rate data, resting heart rate, and heart rate variability will be measured using HealthPatch
Measured: 12 months
Clinician-rated performance status
Clinician-rated ECOG and Karnofsky Performance Status (KPS)
Measured: 12 months
Incidence and number of falls
Measured by HealthPatch
Measured: 12 months
Sleep duration
Measured by Philips Actiwatch
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Natalie Grover, MD, Principal investigator, University of North Carolina, Chapel HillWilliam A Wood, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844400
- Sponsor's protocol ID
- LCCC 1605
- Status last verified
- Feb 2019
- First submitted
- 21 Jul 2016
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Performance Status in Cancer Patients Using Cardiopulmonary Exercise Testing and Wearable Data Generation: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02844400
- Acronym / sponsor ID
- LCCC 1605
- Conditions
- Malignant Solid Tumor, Hematologic Malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 26 Jul 2016 (estimated)
- 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 primary objective of this study is to establish the feasibility and value of physical fitness assessment within patients receiving cytotoxic chemotherapy. If successful, this project will establish the groundwork for physical function assessment in larger cancer clinical trials to assist patient selection and evaluation of toxicity and/or response among trial participants.
Detailed description
Physical fitness, whether measured by performance capacity or daily activity, can predict risk of toxicity while helping to evaluate toxicity itself in the course of cancer chemotherapy. Cytotoxic chemotherapy causes premature aging and frailty in many cancer patients, so measuring and improving physical function may also limit late morbidity and mortality. Clinician-rated performance status (cPS; e.g., ECOG or Karnofsky PS) with or without concomitant organ function testing is the usual gold standard for risk prognostication and patient selection in most cancer settings, but cPS is subjective, unreliable, and relatively sensitive only for patients with significant functional compromise. Objective evaluations of physical function have the potential to augment or even replace cPS in the cancer treatment setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant and Curative Chemotherapy | – | Device: Biometric Devices, Other: Physical Performance Testing30 participants. Primarily older (60+ years in age) cancer patients receiving cytotoxic chemotherapy with adjuvant or curative intent. Will undergo both the Physical Performance Testing and Biometric Devices interventions. |
| Palliative Chemoteraphy | – | Device: Biometric Devices, Other: Physical Performance Testing30 participants. Primarily older (60+ years in age) cancer patients receiving cytotoxic chemotherapy with palliative intent. Will undergo both the Physical Performance Testing and Biometric Devices interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patients with cancer undergoing a cycle of cytotoxic chemotherapy.
Key inclusion criteria (7 listed)
- Patients receiving cytotoxic chemotherapy with at least a 3 week cycle (either adjuvant/curative or palliative)
- Age ≥ 18, prioritizing patients ≥ 60 years
- At least 6 weeks out from surgical resection
- Presence of working email address
- Access to internet at home and either access to wireless internet or cellular data reception
Key exclusion criteria (2 listed)
- Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent
- Contraindication to CPET per standard American Thoracic Society (ATS) guidelines
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 |
|---|---|---|
| Biometric DevicesPatients will wear two devices: HealthPatch Sensor and Phillips Actiwatch. Health data (e.g. average steps per day, resting heart rate) will be collected and monitored over the course of a cycle of cytotoxic chemotherapy. | Device | Adjuvant and Curative Chemotherapy, Palliative Chemoteraphy |
| Physical Performance TestingPatients will complete a CPET and 6 minute walk test within one week of starting an upcoming chemotherapy cycle and they will undergo a second CPET upon completion of said chemotherapy cycle. | Other | Adjuvant and Curative Chemotherapy, Palliative Chemoteraphy |
Primary outcome
Proportion of patients being approached that agree to participate in the study
Time frame: 12 months
Measure 1 for study feasibility
Proportion of patients who complete both baseline and follow up CPET tests without significant testing-related adverse events
Time frame: 12 months
Measure 2 for study feasibility
Proportion of patients who wear HealthPatch and have data captured successfully for at least 75% of the time
Time frame: 12 months
Measure 3 for study feasibility
Patients who wear Philips Actiwatch and have data captured successfully for at least 75% of the time
Time frame: 12 months
Measure 4 for study feasibility
Proportion of patients for whom all data is successfully recorded within the database
Time frame: 12 months
Measure 5 for study feasibility
8 secondary outcomes
VO2max measured both pre- and post-chemotherapy
Time frame: 12 months
6 Minute Walk Distance (6MWD)
Time frame: 12 months
Patient-reported sympotomatic toxicity and quality of life
Time frame: 12 months
Patient activity/steps per day
Time frame: 12 months
Heart rate
Time frame: 12 months
Clinician-rated performance status
Time frame: 12 months
Incidence and number of falls
Time frame: 12 months
Sleep duration
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- UNC Lineberger Comprehensive Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Natalie Grover, MD principal investigator
University of North Carolina, Chapel Hill
William A Wood, MD principal investigator
University of North Carolina, Chapel Hill
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 Malignant Solid Tumor and Hematologic Malignancies, run by UNC Lineberger Comprehensive Cancer 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: finished, as of the sponsor's last update on 22 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients being approached that agree to participate in the study (time frame: 12 months). The study lists 5 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 22 Feb 2019.