Rehabilitation Outcomes Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Malignant Tumor
• Intervention / Treatment: Other: Rehabilitation-based intervention

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Devin McCarthy; Phone Number: 919-966-4432; Email: devin_mccarthy@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • The N.C. Cancer Hospital
      • Contact: Christopher E Jensen, MD; Phone Number: Jensen 984-987-1072; Email: christopher.jensen@unchealth.unc.edu
      • Principal Investigator: Christopher E Jensen, MD
      • Contact: Onoshoze Bossey; Phone Number: 919-962-7446; Email: onoshoze_bossey@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard; Subjects will receive standard of care.
Experimental: Rehabilitation; Subjects will be assessed for rehabilitation and a rehabilitation plan will be generated.	Other: Rehabilitation-based intervention; Assessment of the subject by a specialty consultation and exercise program development.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of rehabilitation interventions accepted	The proportion of pre-treatment rehabilitation intervention performed for patients who are referred to cancer rehabilitation and attend an initial appointment.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction rate	Acceptability in the subjects randomized to the intervention arm will be defined by the proportion of participants who report being "Neutral," & amp;#34; "Satisfied& amp;#34;" or & amp;#34;"Very Satisfied"& amp;#34; with the intervention utilizing the Experience with the Rehabilitation Program questionnaire. The questionnaire has 8 questions measured on a 5-point Likert scale: Not Effective At All=0, Slightly Effective=1, Moderately Effective=2, Very Effective =3, Extremely Effective =4. Minimum score= 0, maximum score=32.	Baseline and post-3 months
Differences in physical function	Differences in physical function in the cancer rehabilitation arm and standard of care arm will be determined using PROMIS Short Form v2.0 Physical Function 4a. The PROMIS Short Form v2.0 - Physical Function 4a is a self-reported measure designed to assess an individual's capability to perform physical activities rather than their actual performance. The form consists of 4 items, each rated on a 5-point Likert scale ranging from "Without any difficulty" to "Unable to do." The scores are then summed to provide a total score, which can be converted to a T-score for standardized interpretation. The T-score has a mean (average) of 50 and a standard deviation of 10. A higher T-score indicates better physical function. Conversely, a lower T-score indicates poorer physical function.	Baseline and post-3 months
Differences in participant activation	Differences in participant activation in the cancer rehabilitation arm and standard of care arm will be determined using Patient Activation Measure (PAM) 10 (Patient Activation Measure 10) scores. The Patient Activation Measure (PAM) 10 is a validated questionnaire designed to assess an individual's knowledge, skills, and confidence in managing their own health and healthcare. It consists of 10 items that measure patient activation, which is the extent to which individuals feel capable of managing their health. The PAM 10 includes 10 statements that respondents rate based on their level of agreement, ranging from "Strongly Disagree" to "Strongly Agree." Responses are scored on a scale from 0 to 100. Higher scores indicate greater patient activation.	Baseline and post-3 months
Differences in overall health	Differences in overall health in the cancer rehabilitation arm and standard of care arm will be determined using PROMIS Global Health (PROMIS Scale v1.2 Global Health) scores. The PROMIS Global Health (PROMIS Scale v1.2 Global Health) is a comprehensive tool designed to assess an individual's overall physical, mental, and social health. The PROMIS Global Health v1.2 includes 10 items that cover various health domains. These items are divided into two main components: Global Physical Health and Global Mental Health. Global Physical Health: This includes items related to physical functioning, pain, fatigue, and overall physical health. Global Mental Health: This includes items related to mental health, emotional distress, and social health.Response Options: Each item is rated on a 5-point Likert scale, with higher scores indicating better health.Raw Scores: The responses are summed to create raw scores for both the Global Physical Health and Global Mental Health components. T-Scores: Th	Baseline and post-3 months
Differences in physical activity levels	Differences in physical activity levels in the cancer rehabilitation arm and standard of care arm will be determined using the Godin Physical Activity Questionnaire (Godin-Shephard Leisure-Time Physical Activity Questionnaire)(GSLTPAQ)) scores. GSLTPAQ is used to assess an individual's physical activity levels during their leisure time. It focuses on the frequency and intensity of physical activities performed over a typical 7-day period. The questionnaire asks the number of times per week they engage in three types of physical activities for more than 15 minutes: Strenuous, Moderate, and Light Exercises. Strenuous exercise examples are running, vigorous swimming, and soccer), moderate exercise examples are fast walking, easy swimming, and volleyball, light exercise examples are yoga, easy walking, and bowling. Scoring: The responses are used to calculate a Leisure Score Index (LSI), which quantifies the total w	Baseline and post-3 months
Overall survival	Overall survival is defined from enrollment to death from any cause and obtained via medical record abstraction.	Up to one year

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Christopher E Jensen, MD, UNC Lineberger Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2025
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 20, 2027

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: LCCC2340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data could be available on request, though there is no plan to store data in any kind of publicly available repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No