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Mayo Clinic Conduit Report Card Questionnaires (CONDUIT) (CONDUIT)

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ClinicalTrials.gov Identifier: NCT02530983
Recruitment Status : Recruiting
First Posted : August 21, 2015
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Shanda Blackmon, M.D., M.P.H., Mayo Clinic

Brief Summary:
The Mayo Clinic Conduit Report Card Questionnaires have been created in order to have a consistent evaluation tools for patients undergoing esophagectomy or esophageal reconstruction in order to standardize and validate outcome measures. Data will be used to establish the validation of the Mayo Clinic Conduit Report Card Questionnaires. Data will also lead to the establishment of "normal" or expected scores for patients undergoing each type of esophagectomy procedure

Condition or disease Intervention/treatment
Esophageal Neoplasms Cancer of Esophagus Cancer of the Esophagus Esophageal Cancer Esophagus Cancer Neoplasm, Esophageal Esophagectomy Other: Mayo Clinic Conduit Report Card Questionnaires

Detailed Description:
The Mayo Clinic Conduit Report Card Questionnaires are a compilation of standard questionnaires and questions that have been created specifically for this study some of which are patient report and others that are administered by the provider or study staff. It includes the Promis Global Health Score, modified Mayo GER Score questions, modified Dysphagia Questionnaire-30 Day questions, and Zubrod Score. It also includes a 10-point scale to grade postoperative pain, milk assessment, Modified Mayo Reflux Score adapted from the Mayo Clinic Reflux Score, Dumping Score adapted from Sigstad's Scoring System, Simple Dysphagia Score adapted from Mellows and Pinkas, Stricture Score adapted from Blackmon, et al., Pyloric Spasm Score, and Conduit Emptying Score abstracted from Vaezi, Baker, Achkar, and Richter. We will also be collecting information on their demographics, operation, nutritional status, laboratory values, testing results and clinical outcomes. Patients will be asked to complete the Mayo Clinic Conduit Report Card Questionnaires at their one month surgical follow up visit and then every three months for 1 year after surgery, then with each surveillance clinic visit or a minimum of once per year for their lifetime. The questionnaire can be completed at their clinic visit, over the telephone, or by mail. The patient's medical record will also be reviewed to gather any other contributing information.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mayo Clinic Conduit Report Card Questionnaires
Study Start Date : August 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Esophagectomy/Esophageal Reconstruction
Patients who have undergone esophagectomy or esophageal reconstruction
Other: Mayo Clinic Conduit Report Card Questionnaires
Patients will be asked to complete the Mayo Clinic Conduit Report Card Questionnaires at their one month surgical follow up visit and then every three months for 1 year after surgery, then with each surveillance clinic visit or a minimum of once per year for their lifetime. The questionnaire can be completed at their clinic visit, over the telephone, or by mail. The patient's medical record will also be reviewed to gather any other contributing information.




Primary Outcome Measures :
  1. Completion of the Mayo Clinic Conduit Report Card Questionnaires by patients at varying time points following surgery [ Time Frame: 1 year ]
    Completed Mayo Clinic Conduit Report Card Questionnaires will be analyzed and used to establish validation.


Secondary Outcome Measures :
  1. Establishment of "normal" or expected scores from the Mayo Clinic Conduit Report Card Questionnaires [ Time Frame: 3 years ]
    Completed Mayo Clinic Conduit Report Card Questionnaires will be used in the establishment of "normal" or expected scores for patients undergoing each type of esophagectomy procedure at different time points following surgery.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing or having already undergone an esophagectomy or esophageal reconstruction.
Criteria

Inclusion Criteria:

  • Patients undergoing or having already undergone an esophagectomy or esophageal reconstruction.

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): NCT02530983


Contacts
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Contact: Karlyn Pierson, MAN, RN 507-538-1960 pierson.karlyn@mayo.edu
Contact: Bettie Lechtenberg, MBA 507-266-4819 lechtenberg.bettie@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Karlyn Pierson, MAN, RN    507-538-1960    pierson.karlyn@mayo.edu   
Contact: Bettie Lechtenberg, MBA    507-266-4819    lechtenberg.bettie@mayo.edu   
Principal Investigator: Shanda Blackmon, MD, MPH, FACS         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Shanda Blackmon, MD, MPH, FACS Mayo Clinic

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Responsible Party: Shanda Blackmon, M.D., M.P.H., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02530983     History of Changes
Other Study ID Numbers: 14-009873
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Esophageal Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases