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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

Tracking Information
First Submitted Date August 18, 2015
First Posted Date August 21, 2015
Last Update Posted Date October 3, 2019
Study Start Date August 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2015)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02530983 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 20, 2015)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mayo Clinic Conduit Report Card Questionnaires (CONDUIT)
Official Title Mayo Clinic Conduit Report Card Questionnaires
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
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing or having already undergone an esophagectomy or esophageal reconstruction.
Condition
  • Esophageal Neoplasms
  • Cancer of Esophagus
  • Cancer of the Esophagus
  • Esophageal Cancer
  • Esophagus Cancer
  • Neoplasm, Esophageal
  • Esophagectomy
Intervention 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.
Study Groups/Cohorts Esophagectomy/Esophageal Reconstruction
Patients who have undergone esophagectomy or esophageal reconstruction
Intervention: Other: Mayo Clinic Conduit Report Card Questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 20, 2015)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients undergoing or having already undergone an esophagectomy or esophageal reconstruction.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Karlyn Pierson, MAN, RN 507-538-1960 pierson.karlyn@mayo.edu
Contact: Bettie Lechtenberg, MBA 507-266-4819 lechtenberg.bettie@mayo.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02530983
Other Study ID Numbers 14-009873
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Shanda Blackmon, M.D., M.P.H., Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Shanda Blackmon, MD, MPH, FACS Mayo Clinic
PRS Account Mayo Clinic
Verification Date October 2019