Recruiting

Observational Study

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06674889

Conditions

Cancer

Malignant Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rehabilitation-based intervention

Study Details

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.

Conditions

Cancer

Malignant Tumor

Study ID

NCT06674889

Start date

Jan 21, 2025

Status verified date

Feb, 2026

Completion date

Jan 20, 2027

Anticipated

Primary completion date

Jan 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard

Subjects will receive standard of care.

experimental: Rehabilitation

Subjects will be assessed for rehabilitation and a rehabilitation plan will be generated.

Interventions

Rehabilitation-based intervention

Assessment of the subject by a specialty consultation and exercise program development.

Primary outcome measure

  • The proportion of rehabilitation interventions accepted [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Devin McCarthy

919-966-4432devin_mccarthy@med.unc.edu

Locations

The N.C. Cancer Hospital

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Onoshoze Bossey

919-962-7446onoshoze_bossey@med.unc.edu

Christopher E Jensen, MD

984-987-1072christopher.jensen@unchealth.unc.edu

Principal Investigator:

Christopher E Jensen, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-02-17.