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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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)?
Show all 9Show fewer
  • 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
  • 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

    Recruiting

Other trials in United States

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.

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 groups in NCT06674889
Study groupRoleWhat they receive
StandardNo interventionSubjects will receive standard of care.
RehabilitationExperimentalSubjects 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted5 Nov 2024
  2. Study start21 Jan 2025
  3. Primary completion20 Jan 2027 (estimated)
  4. Study completion20 Jan 2027 (estimated)

Resources

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)
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.

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.

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