| NCT ID | NCT06674889 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-01-21 |
| Primary Completion | 2027-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-01-21 with a primary completion date of 2027-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information. * Subjects are willing and able to comply with study procedures based on the judgement of the investigator. * Age ≥ 18 years at the time of consent. * The subject has been screened by the Central Oncology Navigation Program and referred to cancer care at the University of North Carolina Medical Center. * Answer "yes" to at least one of the following screening questions: 1. Does your health interfere with any of your activities of daily living (ADLs)? 2. Have you fallen, or do you feel unsteady while standing or walking? 3. Do you use durable medical equipment (DME)? 4. Are you interested in increasing the amount you exercise? Exclusion Criteria: * Inability to read and understand the English language. * Psychological or other disability resulting in the inability to provide informed consent. * Unstable medical comorbidity that precludes safe participation in an exercise program, in the judgment of the clinical investigator. * Prisoners and other institutionalized individuals.
Contact & Investigator
Christopher E Jensen, MD
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06674889 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06674889 currently recruiting?
Yes, NCT06674889 is actively recruiting participants. Contact the research team at devin_mccarthy@med.unc.edu for enrollment information.
Where is the NCT06674889 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06674889 clinical trial?
NCT06674889 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Christopher E Jensen, MD at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 60 participants.
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