RECRUITING

Rehabilitation Outcomes Study

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 pilot health services interventional study aims to prospectively assess the effectiveness of a pre-treatment rehabilitation (prehabilitation) program across a diverse cohort of adult cancer patients via a randomized pilot trial. Upon screening and identification of high-risk features through a central navigation process, patients referred to oncology clinics will be approached to participate in tailored prehabilitation interventions. The study will track and analyze functional outcomes and quality of life aiming to demonstrate the comprehensive benefits of prehabilitation on the cancer treatment continuum. We hypothesize that this referral program is feasible and that those randomized to the intervention arm will have superior functional outcomes and global health-related quality of life. The rationale for this study is anchored in the urgent need to optimize the cancer care trajectory for high-risk patients whose treatment outcomes and quality of life are jeopardized by the multifaceted challenges of their disease. While prehabilitation has shown potential to mitigate these adverse effects, the optimal methods for identifying and connecting these high-risk individuals to appropriate prehabilitation resources remain underexplored. This study, with its systematic approach to enrolling a diverse adult cancer population, endeavors to investigate not only the benefits of prehabilitation interventions but also the effectiveness of a targeted referral process. By doing so, it aims to uncover novel strategies for efficiently allocating prehabilitation resources, thereby enhancing the precision and impact of supportive cancer care.

Official Title

Feasibility and Outcomes of Universal Disability Screening and Cancer Rehabilitation Referral Among Adults With Cancer Referred to the University of North Carolina

Quick Facts

Study Start:2025-01-21
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06674889

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. * Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.
  2. * Subjects are willing and able to comply with study procedures based on the judgement of the investigator.
  3. * Age ≥ 18 years at the time of consent.
  4. * The subject has been screened by the Central Oncology Navigation Program and referred to cancer care at the University of North Carolina Medical Center.
  5. * Answer "yes" to at least one of the following screening questions:
  6. 1. Does your health interfere with any of your activities of daily living (ADLs)?
  7. 2. Have you fallen, or do you feel unsteady while standing or walking?
  8. 3. Do you use durable medical equipment (DME)?
  9. 4. Are you interested in increasing the amount you exercise?
  1. * Inability to read and understand the English language.
  2. * Psychological or other disability resulting in the inability to provide informed consent.
  3. * Unstable medical comorbidity that precludes safe participation in an exercise program, in the judgment of the clinical investigator.
  4. * Prisoners and other institutionalized individuals.

Contacts and Locations

Study Contact

Devin McCarthy
CONTACT
919-966-4432
devin_mccarthy@med.unc.edu

Principal Investigator

Christopher E Jensen, MD
PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

The N.C. Cancer Hospital
Chapel Hill, North Carolina, 27514
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Christopher E Jensen, MD, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer Center

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 Date2025-01-21
Study Completion Date2026-02

Study Record Updates

Study Start Date2025-01-21
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • rehabilitation

Additional Relevant MeSH Terms

  • Cancer
  • Malignant Tumor