Mayo Clinic Upper Digestive Disease Survey (UDD)

Mayo Clinic

Status: Enrolling

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT02530983

14-009873

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

1,000 participants in 2 patient groups

Esophagectomy/Esophageal Reconstruction/Treatment

Description:

Patients who have undergone esophagectomy, esophageal reconstruction, or treatment

Treatment:

Other: Upper Digestive Disease (UDD Monitor) App

Other: Mayo Clinic Upper Digestive Disease Survey on Paper

Upper Digestive Disease

Description:

Patients who have an upper digestive disease.

Treatment:

Other: Upper Digestive Disease (UDD Monitor) App

Other: Mayo Clinic Upper Digestive Disease Survey on Paper