Rehabilitation Outcomes Study

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT06674889
Status
Recruiting

Conditions

  • Cancer
  • Malignant Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rehabilitation-based intervention — OTHER
    Assessment of the subject by a specialty consultation and exercise program development.

Study Details

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.

Key Dates

Start date
Jan 21, 2025
Status verified
Feb 2026
Primary completion
Jan 20, 2027
Completion
Jan 20, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The N.C. Cancer HospitalChapel HillNorth Carolina27514
Onoshoze Bossey
919-962-7446
Christopher E Jensen, MD
984-987-1072
Christopher E Jensen, MD (PRINCIPAL_INVESTIGATOR)

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