Prehabilitation for Cancer

Overseen By Devin McCarthy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Unstable medical comorbidity, prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether starting a rehabilitation program before cancer treatment can improve patients' daily function and overall quality of life. Participants will be divided into two groups: one receiving usual care and another following a personalized rehabilitation plan (rehabilitation-based intervention). The trial aims to determine if this pre-treatment approach helps patients cope better with cancer treatment. Individuals referred to cancer care who feel their health affects daily activities, have balance issues, use medical equipment, or wish to exercise more might be suitable candidates. As an unphased trial, this study offers a unique opportunity for patients to potentially enhance their quality of life before beginning cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this prehabilitation program is safe for cancer patients?

A previous study showed that prehabilitation programs improve both physical and mental health outcomes for cancer patients. Patients often experience fewer post-surgery problems and feel better overall. Additionally, about 71% of studies have shown that patients manage daily activities more effectively after cancer rehabilitation. While some cancer treatments cause tiredness and hinder mobility, prehabilitation appears to reduce these effects. Overall, research suggests that these programs are generally well-received and beneficial for patients undergoing cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the rehabilitation-based intervention for cancer because it offers a proactive approach to patient care. Unlike traditional treatments that typically focus on managing symptoms or targeting cancer cells directly, this intervention aims to enhance a patient's physical and mental readiness before cancer treatment even begins. By developing personalized rehabilitation plans, it helps build strength, improve overall fitness, and potentially mitigate treatment-related side effects. This approach is unique because it empowers patients, potentially leading to better treatment outcomes and a higher quality of life during and after cancer therapy.

What evidence suggests that this prehabilitation program is effective for cancer patients?

Research shows that preparing the body before cancer treatment, known as prehabilitation, can be very helpful. In this trial, participants in the rehabilitation arm will receive an assessment and a personalized rehabilitation plan. Studies have found that patients who underwent prehabilitation often felt less tired and remained more active during treatment. This preparation can enhance overall function and well-being. Another review found that rehabilitation efforts after cancer can improve quality of life. Evidence suggests that prehabilitation helps patients better manage the challenges of cancer treatment. ^{2 3 4 6 7}

Who Is on the Research Team?

Christopher E. Jensen

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult cancer patients who are considered high-risk and referred to oncology clinics. They must be able to participate in a prehabilitation program before starting their cancer treatment. Specific criteria for what makes someone 'high-risk' aren't provided, so it's likely determined by the referring clinic or study staff.

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

The subject has been screened by the Central Oncology Navigation Program and referred to cancer care at the University of North Carolina Medical Center

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo tailored prehabilitation interventions to improve functional outcomes and quality of life before cancer treatment

3 months

Regular visits as per intervention plan

Follow-up

Participants are monitored for safety and effectiveness after prehabilitation interventions

3 months

Baseline and post-3 months assessments

What Are the Treatments Tested in This Trial?

Interventions

• Rehabilitation-based intervention

Trial Overview

The study tests if a pre-treatment rehabilitation (prehabilitation) program can improve functional outcomes and quality of life in high-risk cancer patients. Participants will be randomly assigned to either receive tailored prehab interventions or not, allowing comparison between groups.

How Is the Trial Designed?

Group I: Rehabilitation Experimental Treatment 1 Intervention

Subjects will be assessed for rehabilitation and a rehabilitation plan will be generated.

Group II: Standard Active Control 1 Intervention

Subjects will receive standard of care.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Published Research Related to This Trial

Cancer prehabilitation, which includes exercise, nutrition, education, psychological counseling, and smoking cessation, can enhance functional status and improve outcomes for patients undergoing cancer treatment.

Oncology nurses play a vital role in promoting prehabilitation by assessing patients' needs, advocating for these services, and educating survivors about their benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role and Scope of Prehabilitation in Cancer Care. Lukez, A., Baima, J.[2021]

Patient-centric prehabilitation in oncology is essential for enhancing patient experiences and improving overall health outcomes while also reducing healthcare costs.

Nurses play a crucial role in the prehabilitation process, from patient assessment to intervention implementation, highlighting the need for more research and education to support interdisciplinary prehabilitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation. An Interdisciplinary Patient-Centric Conceptual Framework. Renouf, T., Bates, A., Davis, JF., et al.[2022]

Prehabilitation, which includes exercise, nutrition, and psychoeducation, has been shown to improve various health outcomes such as gait, cardiopulmonary function, and mood in cancer patients 30 days post-treatment, based on a review of 16 randomized controlled trials with 2017 participants.

Combining prehabilitation with rehabilitation yielded greater improvements in physical functioning compared to prehabilitation alone, highlighting the need for larger studies to confirm these benefits and enhance long-term outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation for adults diagnosed with cancer: A systematic review of long-term physical function, nutrition and patient-reported outcomes. Faithfull, S., Turner, L., Poole, K., et al.[2020]

Prehabilitation, which involves rehabilitation strategies before intensive cancer treatments, has been shown to improve functional outcomes and tolerability for patients undergoing surgery and other anti-cancer therapies.

Current evidence supports the integration of prehabilitation as a standard practice in oncology care, with future research needed to explore its effects on treatment responses and disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation is the Gateway to Better Functional Outcomes for Individuals with Cancer. Stout, NL., Fu, JB., Silver, JK.[2022]

Citations

1.

bmccancer.biomedcentral.com

bmccancer.biomedcentral.com/articles/10.1186/s12885-024-13023-w

Efficacy of Prehabilitation in cancer patients: an Rcts ...

Patients with cancer (PwC) who undergo specific treatments reported greater fatigue and reduced functional capacity as predominant outcomes, ...

2.

bmj.com

bmj.com/content/388/bmj-2024-081164

Relative efficacy of prehabilitation interventions and their ...

Objective To estimate the relative efficacy of individual and combinations of prehabilitation components (exercise, nutrition, cognitive, ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11494964/

Efficacy of Prehabilitation in cancer patients: an Rcts ...

Patients with cancer (PwC) who undergo specific treatments reported greater fatigue and reduced functional capacity as predominant outcomes, ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0003999322001654

Systematic Review of Functional Outcomes in Cancer ...

These findings provide evidence supporting the efficacy of rehabilitative interventions for individuals with a cancer history.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06674889

NCT06674889 | Rehabilitation Outcomes Study

The study will track and analyze functional outcomes and quality of life aiming to demonstrate the comprehensive benefits of prehabilitation on the cancer ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11477470/

A Comprehensive Narrative Review of Cancer ...

Reports indicate that prehabilitation programmes can improve outcomes for physical and mental health, leading to reduced surgical complications, ...

7.

bmjopen.bmj.com

bmjopen.bmj.com/content/15/7/e093832

An assessment of study characteristics, quality and ...

This scoping review describes the characteristics and quality of reporting of prehabilitation exercise interventions for adults living with cancer.