ACTIVE_NOT_RECRUITING

An Evaluation of Patient Reported Outcomes and Clinical Outcomes

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Conditions

Post-Operative Complications in Cardiac Surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery: * Patient reported outcomes (PRO), using the EQ-5D questionnaire * Clinical outcomes

Official Title

Clinical Protocol REN-007E - Extension Study: An Evaluation of Patient Reported Outcomes and Clinical Outcomes Through 12 Months Post-Cardiac Surgery in Subjects Enrolled in Study REN-007

Quick Facts

Study Start:2023-10-16
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06092970

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects must have completed the REN-007 study to be eligible to participate in the Extension Study.
  1. * Subjects who did not complete the REN-007 study are not eligible to participate in the Extension Study.
  2. * Female subjects who become pregnant during the REN-007 study are not eligible to participate in the Extension Study.

Contacts and Locations

Study Locations (Sites)

Research Site
Huntsville, Alabama, 35801
United States
Research Site
San Francisco, California, 94107
United States
Research Site
Stanford, California, 94305
United States
Research Site
Washington, District of Columbia, 20010
United States
Research Site
Atlantis, Florida, 33462
United States
Research Site
Gainesville, Florida, 32608
United States
Research Site
Athens, Georgia, 30606
United States
Research Site
Atlanta, Georgia, 30342
United States
Research Site
Fort Wayne, Indiana, 46804
United States
Research Site
Indianapolis, Indiana, 46202
United States
Research Site
Indianapolis, Indiana, 46237
United States
Research Site
Kansas City, Kansas, 66160
United States
Research Site
Boston, Massachusetts, 02115
United States
Research Site
Ann Arbor, Michigan, 48109
United States
Research Site
Lansing, Michigan, 48879
United States
Research Site
Midland, Michigan, 48670
United States
Research Site
Royal Oak, Michigan, 48073
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
Saint Louis, Missouri, 63310
United States
New York Presbyterian-Queens
Flushing, New York, 11355
United States
Research Site
Raleigh, North Carolina, 27610
United States
Research Site
Winston-Salem, North Carolina, 27157
United States
Research Site
Cleveland, Ohio, 44106
United States
Research Site
Toledo, Ohio, 43606
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Dallas, Texas, 75390
United States
Research Site
Houston, Texas, 77030
United States
Research Site
San Antonio, Texas, 78229
United States
Research Site
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: Renibus Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-16
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-10-16
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Post-Operative Complications in Cardiac Surgery