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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02511821
Recruitment Status : Active, not recruiting
First Posted : July 30, 2015
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Stage I Adult Liver Cancer Stage I Colorectal Cancer Stage IA Gastric Cancer Stage IA Pancreatic Cancer Stage IB Gastric Cancer Stage IB Pancreatic Cancer Stage II Adult Liver Cancer Stage IIA Colorectal Cancer Stage IIA Gastric Cancer Stage IIA Pancreatic Cancer Stage IIB Colorectal Cancer Stage IIB Gastric Cancer Stage IIB Pancreatic Cancer Stage IIC Colorectal Cancer Stage III Pancreatic Cancer Stage IIIA Adult Liver Cancer Stage IIIA Colorectal Cancer Stage IIIA Gastric Cancer Stage IIIB Adult Liver Cancer Stage IIIB Colorectal Cancer Stage IIIB Gastric Cancer Stage IIIC Adult Liver Cancer Stage IIIC Colorectal Cancer Stage IIIC Gastric Cancer Stage IV Gastric Cancer Stage IVA Colorectal Cancer Stage IVA Liver Cancer Stage IVA Pancreatic Cancer Stage IVB Colorectal Cancer Stage IVB Liver Cancer Stage IVB Pancreatic Cancer Other: Computer-Assisted Intervention Device: Vivofit watch Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. 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.

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

SECONDARY OBJECTIVES:

I. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Electronic Monitoring of Patient-Reported Outcomes and Function in GI Cancer Surgery: A Feasibility Study
Study Start Date : July 22, 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive Care (Vivofit watch, online surveys)
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.
Other: Computer-Assisted Intervention
Complete online surveys

Device: Vivofit watch
Wear Vivofit watch
Other Name: Monitor

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Mean time patients are able to tolerate wearing the wristband device, both before and after surgery [ Time Frame: Up to 1 month ]
    Descriptive statistics will be used to describe the distribution of time (before and after surgery) a patient is able to wear the wristband device.

  2. Mean time to complete the web based questionnaires MDASI and EQ-5D, as well as the Self Geriatric Assessment Measure [ Time Frame: Up to 1 month ]
    Descriptive statistics will be used to describe the distribution of time to complete each assessment.

  3. Median time patients are able to tolerate wearing the wristband device, both before and after surgery [ Time Frame: Up to 1 month ]
    Descriptive statistics will be used to describe the distribution of time (before and after surgery) a patient is able to wear the wristband device.

  4. Median time to complete the web based questionnaires MDASI and EQ-5D, as well as the Self Geriatric Assessment Measure [ Time Frame: Up to 1 month ]
    Descriptive statistics will be used to describe the distribution of time to complete each assessment.

  5. Percentage of patients who are able to complete the web-based questionnaires MDASI and EQ-5D [ Time Frame: Up to 1 month ]
    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.

  6. Percentage of patients who are able to wear the wristband device for at least 1 week post-operatively [ Time Frame: Up to 1 week post-operatively ]
    Estimated with 95% confidence interval of half-width no more than 16%.


Secondary Outcome Measures :
  1. Ease of use of web-based surveys and wristband device, as measured by responses from Satisfaction Tool [ Time Frame: 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 [ Time Frame: Up to 1 month ]
  3. Feedback on length of surveys and timing of administration, as measured by responses from Satisfaction Tool [ Time Frame: Up to 1 month ]
  4. Mean number of missing items within each questionnaire [ Time Frame: Up to 1 month ]
    Mean number of missing items within each questionnaire will be calculated to identify individual or subsets of questions that are difficult to answer.

  5. Percentage of patients who did not enroll in the study-composite outcome of multiple measure listed [ Time Frame: Up to 1 month ]
    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.

  6. Suggestions for items that were not covered but should be added, as measured by responses from Satisfaction Tool [ Time Frame: Up to 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02511821


Locations
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United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Virginia Sun City of Hope Medical Center

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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT02511821    
Other Study ID Numbers: 15051
NCI-2015-01061 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
15051 ( Other Identifier: City of Hope Medical Center )
P30CA033572 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2015    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Colorectal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Liver Neoplasms
Carcinoma, Hepatocellular
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type