AzTrials
AzTrials

Malignant Solid TumourNCT02786628

Assessing Physical Fitness in Cancer Patients With Cardiopulmonary Exercise Testing and Wearable Data Generation

An observational study of Malignant Solid Tumour and Hematologic Malignancies, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to assess the feasibility of a multi-institutional study that collects cardiopulmonary exercise testing and 6 minute walk distance performance testing prior to a cycle of chemotherapy (or transplant), followed by collection of patient generated health data (wearable activity… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Physical performance testing and patient-generated health data
How many people
43 participants
Where
1 siteUnited States
Study dates
Feb 2016to Feb 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: 45 patients with cancer undergoing a cycle of cytotoxic chemotherapy or bone marrow transplant.

Who may be able to join

  • Patients with solid tumor or hematologic malignancies who are planning to receive a cycle of cytotoxic chemotherapy or patients who are planning to receive stem cell transplant.
  • Age ≥ 18
  • At least 6 weeks out from surgical resection
  • Presence of working email address
  • Access to internet at home and access to electronic device(s) capable of charging and syncing the Fitbit
  • Ability to read and understand English
Show all 10Show fewer
  • Ability to understand and comply with study procedures including wearing Fitbit for the entire length of the study
  • Approval of attending oncologist for participation in the study
  • Hb ≥ 8 g/dL (most recent lab draw)
  • Willingness and ability to provide written informed consent

Who cannot join

  • Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent
  • Presence of cardiac disease including acute MI within past 6 weeks, unstable angina, uncontrolled arrhythmias causing symptoms, active endocarditis, myocarditis, or pericarditis,symptomatic aortic stenosis, uncontrolled heart failure, syncope in the past 6 weeks, severe untreated hypertension at rest (>180 mmHg systolic, >100 mmHg diastolic)
  • Acute pulmonary embolism or thrombosis of lower extremities in the past 6 weeks
  • Uncontrolled asthma
  • Pulmonary edema
  • Suspected dissecting aneurysm
Show all 11Show fewer
  • Room air desaturation at rest </= 88%
  • Respiratory failure
  • Acute noncardiopulmonary disorder that may be aggravated by exercise
  • Mental impairment leading to inability to cooperate with instructions
  • Orthopedic impairment that compromises exercise performance

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

The primary objective of this study is to assess the feasibility of a multi-institutional study that collects cardiopulmonary exercise testing and 6 minute walk distance performance testing prior to a cycle of chemotherapy (or transplant), followed by collection of patient generated health data (wearable activity monitors and patient reported outcomes) for the subsequent month. In addition to demonstrating feasibility, the study looks to generate preliminary data that supports the capacity of physical performance testing and patient-generated health data to complement clinician-rated performance status in patients receiving chemotherapy.

Read the detailed description

Physical fitness, based on tests of physical performance and measurements of daily activity, can serve as both a risk stratification variable and clinical outcome for patients prior to or during cytotoxic chemotherapy. Many cytotoxic therapies cause premature aging and frailty in a sizable portion of patients, so measuring and improving physical function may also limit late morbidity and mortality in certain patient populations. Clinician-rated performance status (cPS; e.g., ECOG or Karnofsky PS) in addition to organ-specific function have been used to prognosticate risk and determine treatment strategy, but cPS only readily identifies individuals with significant functional compromise. Objective evaluations of physical function, such as aerobic capacity and measured daily activity, may have greater potential to improve the precision of performance status evaluation.

Being tested
Physical performance testing and patient-generated health data
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical performance testing and patient-generated health dataOther

    All patients will complete cardiopulmonary exercise testing and 6 minute walk distance performance testing prior to a cycle of chemotherapy (or transplant) and wear a Fitbit Charge HR for the duration of one cycle of chemotherapy.

Study groups in NCT02786628
Study groupRoleWhat they receive
Solid tumor malignancies15 patients. Will participate in physical performance testing and patient-generated health data.
Receives: Other: Physical performance testing and patient-generated health data
Hematologic malignancies15 patients. Will participate in physical performance testing and patient-generated health data.
Receives: Other: Physical performance testing and patient-generated health data
Hematopoietic cell transplantation15 patients. Will participate in physical performance testing and patient-generated health data.
Receives: Other: Physical performance testing and patient-generated health data

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients being approached that agree to participate in the study

    This is measure 1 for determining study feasibility

    Measured: 7 months

  2. Proportion of enrolled patients who complete CPET and 6MWD test without significant testing-related adverse events

    This is measure 2 for determining study feasibility

    Measured: 7 months

  3. Proportion of recruited patients who wear Fitbit for at least 8 hours per day

    This is measure 3 for determining study feasibility

    Measured: 7 months

  4. Proportion of patients for whom all data is successfully recorded within database

    This is measure 4 for determining study feasibility; using UNC PRO-Core and Fitabase to collect information

    Measured: 7 months

Secondary outcomes (6)

  1. Compare pre-treatment aerobic capacity (VO2max or 6MWD) with post-treatment average measured steps per day

    Comparison made to determine if pre-treatment aerobic capacity is predictive of post-treatment steps per day.

    Measured: 7 months

  2. Compare pre-treatment clinician-rated performance status and aerobic capacity (VO2max or 6MWD) with post-treatment average steps per day

    Comparison made to determine which pre-treatment value better predicts post-treatment steps per days.

    Measured: 7 months

  3. Compare pre-treatment aerobic capacity (VO2max or 6MWD) and post-treatment average measured steps per day among the three cohorts (solid tumor, hematologic malignancies, hematopoietic cell transplantation)

    Measured: 7 months

  4. Compare average measured steps per day and patient-reported symptomatic toxicities

    Measured: 7 months

  5. Compare resting heart rate trajectories (as measured by Fitbit) before and after chemotherapy

    Measured: 7 months

  6. Compare resting heart rates as measured from VO2max testing with resting heart rates as measured by Fitbit

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

Resources

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
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02786628
Sponsor's protocol ID
LCCC 1543
Status last verified
Mar 2018
First submitted
23 May 2016
Last updated
22 Mar 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Wood WA, Dilip D, Derkach A, Grover NS, Elemento O, Levine R, Thanarajasingam G, Batsis JA, Bailey C, Kannappan A, Devine SM, Artz AS, Ligibel JA, Basch E, Kent E, Glass J. Wearable sensor-based performance status assessment in cancer: A pilot multicenter study from the Alliance for Clinical Trials in Oncology (A19_Pilot2). PLOS Digit Health. 2023 Jan 26;2(1):e0000178. doi: 10.1371/journal.pdig.0000178. eCollection 2023 Jan.

    PubMed 36812616

Questions about this trial

What is this clinical trial studying?

An observational study of Malignant Solid Tumour 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 10 inclusion and 11 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 Mar 2018. 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: 7 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02786628, which also lists 1 linked publication.

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 Mar 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in