Mayo Clinic Upper Digestive Disease Survey

Esophageal Cancer Clinical Trial

— UDD  

Official title:

Mayo Clinic Upper Digestive Disease Survey

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02530983
• Other study ID #: 14-009873
• Status: Recruiting
• Start date: August 2015
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Mohamad Khair Abou Chaar, MD
• Phone: 507-422-9936
• Email: AbouChaar.MohamadKhairM[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Mayo Clinic Conduit Report Card Questionnaires have been created in order to have a consistent evaluation tools for patients undergoing esophageal reconstruction or treatment or patients that are experiencing an upper digestive disease in order to standardize and validate outcome measures. Data will be used to establish the validation of the questionnaires/survey. Data will also lead to the establishment of "normal" or expected scores for patients undergoing each type of esophagectomy procedure and for upper digestive diseases. Data will contribute to creating treatment algorithms for symptom management for upper digestive diseases and for post-operative complications and symptoms as well as contribute to pre-operative education.

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 Upper Digestive Disease Survey 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 for patients who undergo surgery and at one month following diagnosis and then every three months for 1 year after diagnosis, then with each surveillance clinic visit or a minimum of once per year for their lifetime for patients that do not undergo surgery. The questionnaire can be completed at their clinic visit, over the telephone, or by mail using the paper form or may be completed using an electronic application. The electronic version is available for Mayo Clinic and non Mayo Clinic patients through the app store in conjunction Mayo IT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Cancer of Esophagus
• Cancer of the Esophagus
• Congenital Abnormalities
• Digestive System Abnormalities
• Digestive System Diseases
• Esophageal Cancer
• Esophageal Neoplasms
• Esophagectomy
• Esophagus Cancer
• Gastrointestinal Diseases
• Neoplasm, Esophageal
• Neoplasms

Intervention

Other:
• Mayo Clinic Upper Digestive Disease Survey on Paper
Mayo Clinic patients will be asked to complete the Mayo Clinic Upper Digestive Disease Survey 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.
• Upper Digestive Disease (UDD Monitor) App
Mayo Clinic and non Mayo Clinic patients can participate by loading the app through the app store. Patient consent will be completed in the app. Patients will be asked to complete questionnaires at their 1.5 month surgical or diagnosis follow up and then every three months for 1 year after their surgery or diagnosis, then with each surveillance clinic visit or a minimum of once per year for their lifetime or as long as they want to participate. for iOS: https://apps.apple.com/us/app/upper-digestive-disease/id6448756724 for Android: https://play.google.com/store/apps/details?id=com.mayoclinic.uddmobile&pli=1

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of the Mayo Clinic Upper Digestive Disease Survey by patients at varying time points following surgery	Completed Mayo Clinic Upper Digestive Disease Survey will be analyzed and used to establish validation.	1 year
Secondary	Establishment of "normal" or expected scores from the Mayo Clinic Upper Digestive Disease Survey	Completed Mayo Clinic Upper Digestive Disease Survey 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.	3 years