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Stage I Adult Liver CancerNCT02511821

Electronic Monitoring Device of Patient-Reported Outcomes and Function in Improving Patient-Centered Care in Patients With Gastrointestinal Cancer Undergoing Surgery

A study testing Computer-Assisted Intervention, Vivofit watch and Quality-of-Life Assessment in people with Stage I Adult Liver Cancer and Stage I Colorectal Cancer, run by City of Hope Medical 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
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Trial summary

This pilot clinical trial studies an electronic monitoring device of patient-reported outcomes (PROs) and function in improving patient-centered care in patients with gastrointestinal cancer undergoing surgery. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Computer-Assisted Intervention, Vivofit watch and Quality-of-Life Assessment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
22 Jul 2015to 31 Jul 2016
Phase
Interventional
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Scheduled to undergo surgery for primary or secondary gastric, colorectal, liver, or pancreas cancer
  • Able to read and understand English
  • Patients across all stages of disease
  • There are no restrictions related to performance status or life expectancy
  • This protocol is eligible for waiver of informed consent documentation; all subjects must have the ability to understand and the willingness to provide verbal informed consent

Who cannot join

  • Research participants who have no computer and internet access and/or do not use a computer even if one is present in the household
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: Electronic Monitoring of Patient-Reported Outcomes and Function in GI Cancer Surgery: A Feasibility Study

This pilot clinical trial studies an electronic monitoring device of patient-reported outcomes (PROs) and function in improving patient-centered care in patients with gastrointestinal cancer undergoing surgery. Electronic monitoring is a technology-based way of asking patients about the quality of life, symptoms, and activity using online surveys and an activity tracking watch may make it easier for patients to tell their doctors and nurses about any issues before and after surgery. Electronic systems of assessing PROs may increase the depth and accuracy of available clinical data, save administrative time, prompt early intervention that improves the patient experience, foster patient-provider communication, improve patient safety, and enhance the consistency of data collection across multiple sites.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the feasibility of administration of electronic patient-reported outcomes and functional assessment in gastrointestinal (GI) cancer surgery (gastric, colorectal, liver, pancreas).

II. Determine percentage of patients able to complete > 80% of MD. Anderson Symptom Inventory (MDASI) and European Quality of LIfe-5 Dimensions (EQ-5D) web-based surveys.

III. Determine percentage of patients able to wear the wristband device at least 1 week post-operatively.

IV. Determine length of time to complete the web-based surveys.

  1. Determine length of time patients are able to wear the wristband device, before and after surgery.

SECONDARY OBJECTIVES:

  1. Determine the percentage of patients who did not enroll in the study and analyze the reasons why. This will be accomplished using: 1) the number of patients asked to participate; 2) the number of patients who declined to participate, and 3) reasons for declining participation.

II. Responses from the Satisfaction Tool will be used to assess: 1) ease of use of web-based surveys and wristband device; 2) feedback on items in the web-based surveys that are distressing or difficult to comprehend; 3) feedback on length of surveys and timing of administration; and 4) suggestions for items that were not covered but should be added.

III. Calculate the mean number of missing items within each questionnaire to identify individual or subsets of questions that are difficult to answer.

OUTLINE:

Patients complete online surveys comprising questions about quality of life, symptoms, and activity level, and wear a wristband device (Vivofit watch) 3-7 days prior to and after surgery. After going home, patients complete the symptom survey three times a week and quality of life survey once a week for 2 weeks post-surgery.

After completion of study, patients are followed up for 1 month.

Being tested
Computer-Assisted Intervention, Vivofit watch, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Carcinoma, Hepatocellular, Colorectal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Liver Neoplasms

What participants receive

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

  • Computer-Assisted InterventionOther

    Complete online surveys

  • Vivofit watchDevice

    Also called Monitor

    Wear Vivofit watch

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT02511821
Study groupRoleWhat they receive
Supportive Care (Vivofit watch, online surveys)ExperimentalPatients complete online surveys comprising questions about quality of life, symptoms, and activity level, and wear a wristband device (Vivofit watch) 3-7 days prior to and after surgery. After going home, patients complete the symptom survey three times a week and quality of life survey once a week for 2 weeks post-surgery.
Receives: Other: Computer-Assisted Intervention; Device: Vivofit watch; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

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

  1. Mean time patients are able to tolerate wearing the wristband device, both before and after surgery

    Descriptive statistics will be used to describe the distribution of time (before and after surgery) a patient is able to wear the wristband device.

    Measured: Up to 1 month

  2. Mean time to complete the web based questionnaires MDASI and EQ-5D, as well as the Self Geriatric Assessment Measure

    Descriptive statistics will be used to describe the distribution of time to complete each assessment.

    Measured: Up to 1 month

  3. Median time patients are able to tolerate wearing the wristband device, both before and after surgery

    Descriptive statistics will be used to describe the distribution of time (before and after surgery) a patient is able to wear the wristband device.

    Measured: Up to 1 month

  4. Median time to complete the web based questionnaires MDASI and EQ-5D, as well as the Self Geriatric Assessment Measure

    Descriptive statistics will be used to describe the distribution of time to complete each assessment.

    Measured: Up to 1 month

  5. Percentage of patients who are able to complete the web-based questionnaires MDASI and EQ-5D

    Descriptive statistics will be reported. Patients who complete at least 80% of all scheduled MDASI and EQ-5D questionnaires will be indicated as able to complete the web-based questionnaires. The true population proportion will be estimated with 95% confidence interval of half-width no more than 0.16.

    Measured: Up to 1 month

  6. Percentage of patients who are able to wear the wristband device for at least 1 week post-operatively

    Estimated with 95% confidence interval of half-width no more than 16%.

    Measured: Up to 1 week post-operatively

Secondary outcomes (6)

  1. Ease of use of web-based surveys and wristband device, as measured by responses from Satisfaction Tool

    Measured: Up to 1 month

  2. Feedback on items in the web-based surveys that are distressing or difficult to comprehend, as measured by responses from Satisfaction Tool

    Measured: Up to 1 month

  3. Feedback on length of surveys and timing of administration, as measured by responses from Satisfaction Tool

    Measured: Up to 1 month

  4. Mean number of missing items within each questionnaire

    Mean number of missing items within each questionnaire will be calculated to identify individual or subsets of questions that are difficult to answer.

    Measured: Up to 1 month

  5. Percentage of patients who did not enroll in the study-composite outcome of multiple measure listed

    Percentage of patients who did not enroll in the study will be determined and the reasons why will be analyzed. This will be accomplished using: i) the number of patients asked to participate, ii) the number of patients who declined to participate, and iii) reasons for declining participation.

    Measured: Up to 1 month

  6. Suggestions for items that were not covered but should be added, as measured by responses from Satisfaction Tool

    Measured: Up to 1 month

Timeline

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

  1. First posted30 Jul 2015 (estimated)
  2. Study start22 Jul 2015
  3. Primary completion31 Jul 2016
  4. Study completion31 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02511821
Sponsor's protocol ID
15051
Other IDs
NCI-2015-01061, 15051, P30CA033572
Status last verified
Jan 2021
First submitted
26 Jun 2015
Last updated
7 Jan 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Computer-Assisted Intervention, Vivofit watch and Quality-of-Life Assessment in people with Stage I Adult Liver Cancer and Stage I Colorectal Cancer, run by City of Hope Medical 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 5 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 7 Jan 2021. 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?

Mean time patients are able to tolerate wearing the wristband device, both before and after surgery (time frame: Up to 1 month). The study lists 6 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 NCT02511821.

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 7 Jan 2021.

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