Mayo Clinic Upper Digestive Disease Survey

NCT02530983 | Recruiting

• 1 other identifier: 14-009873
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Neoplasms; Cancer of Esophagus; Cancer of the Esophagus; Esophageal Cancer; Esophagus Cancer; Neoplasm, Esophageal; Esophagectomy; Abnormalities, Digestive System; Digestive System Abnormalities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Establishment of "normal" or expected scores from the Mayo Clinic Upper Digestive Disease Survey

  3 years

Study Arms (2)

Esophagectomy/Esophageal Reconstruction/Treatment

Patients who have undergone esophagectomy, esophageal reconstruction, or treatment

Other: Mayo Clinic Upper Digestive Disease Survey on Paper; Other: Upper Digestive Disease (UDD Monitor) App

Upper Digestive Disease

Patients who have an upper digestive disease.

Other: Mayo Clinic Upper Digestive Disease Survey on Paper; Other: Upper Digestive Disease (UDD Monitor) App

Interventions

Mayo Clinic Upper Digestive Disease Survey on Paper OTHER

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.

Esophagectomy/Esophageal Reconstruction/Treatment; Upper Digestive Disease

Upper Digestive Disease (UDD Monitor) App OTHER

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

Esophagectomy/Esophageal Reconstruction/Treatment; Upper Digestive Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Digestive System Abnormalities

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Luis Tapias Vargas, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamad Khair Abou Chaar, MD

CONTACT

507-422-9936; AbouChaar.MohamadKhairM@mayo.edu

Karlyn Pierson, MAN, RN

CONTACT

507-538-1960; pierson.karlyn@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 21, 2015
• Study Start: August 15, 2015
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)