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Rehabilitation Outcomes Study

UNC Lineberger Comprehensive Cancer Center logo

UNC Lineberger Comprehensive Cancer Center

Status

Enrolling

Conditions

Malignant Tumor
Cancer

Treatments

Other: Rehabilitation-based intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06674889
LCCC2340

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Standard
No Intervention group
Description:
Subjects will receive standard of care.
Rehabilitation
Experimental group
Description:
Subjects will be assessed for rehabilitation and a rehabilitation plan will be generated.
Treatment:
Other: Rehabilitation-based intervention

Trial contacts and locations

1

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Central trial contact

Devin McCarthy

Data sourced from clinicaltrials.gov

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