CancerNCT06674889
Rehabilitation Outcomes Study
A study testing Rehabilitation-based intervention in people with Cancer and Malignant Tumor, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Malignant Tumor
- What is being tested?
- Rehabilitation-based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Does your health interfere with any of your activities of daily living (ADLs)?
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- Have you fallen, or do you feel unsteady while standing or walking?
- Do you use durable medical equipment (DME)?
- Are you interested in increasing the amount you exercise?
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The N.C. Cancer Hospital
Chapel Hill, North Carolina, 27514
Onoshoze Bossey, 919-962-7446, onoshoze_bossey@med.unc.edu
Christopher E Jensen, MD, 984-987-1072 ext. Jensen, christopher.jensen@unchealth.unc.edu
About this study
Official title: 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.
- Conditions
- Cancer, Malignant Tumor
- Being tested
- Rehabilitation-based intervention
- Keywords
- rehabilitation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation-based interventionOther
Assessment of the subject by a specialty consultation and exercise program development.
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Subjects will receive standard of care. |
| Rehabilitation | Experimental | Subjects will be assessed for rehabilitation and a rehabilitation plan will be generated. Receives: Other: Rehabilitation-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline and post-3 months
Overall survival
Overall survival is defined from enrollment to death from any cause and obtained via medical record abstraction.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start21 Jan 2025
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher E Jensen, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674889
- Sponsor's protocol ID
- LCCC2340
- Status last verified
- Feb 2026
- First submitted
- 4 Nov 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data could be available on request, though there is no plan to store data in any kind of publicly available repository.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Survival and Outcomes Impact of Universal Disability Screening and Cancer Rehabilitation Referral Among Adults With Cancer Referred to the University of North Carolina
- ClinicalTrials.gov ID
- NCT06674889
- Acronym / sponsor ID
- LCCC2340
- Conditions
- Cancer, Malignant Tumor
- Keywords
- rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Subjects will receive standard of care. |
| Rehabilitation | Experimental | Other: Rehabilitation-based interventionSubjects will be assessed for rehabilitation and a rehabilitation plan will be generated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation-based interventionAssessment of the subject by a specialty consultation and exercise program development. | Other | Rehabilitation |
Primary outcome
The proportion of rehabilitation interventions accepted
Time frame: Baseline
The proportion of pre-treatment rehabilitation intervention performed for patients who are referred to cancer rehabilitation and attend an initial appointment.
6 secondary outcomes
Satisfaction rate
Time frame: Baseline and post-3 months
Differences in physical function
Time frame: Baseline and post-3 months
Differences in participant activation
Time frame: Baseline and post-3 months
Differences in overall health
Time frame: Baseline and post-3 months
Differences in physical activity levels
Time frame: Baseline and post-3 months
Overall survival
Time frame: Up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No. Data could be available on request, though there is no plan to store data in any kind of publicly available repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher E Jensen, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation-based intervention in people with Cancer and Malignant Tumor, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devin McCarthy (919-966-4432, devin_mccarthy@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of rehabilitation interventions accepted (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.