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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Rehabilitation-based intervention for cancer patients?

Research shows that prehabilitation, which includes physical and psychological preparation before cancer treatment, can improve patients' physical and mental health, reduce treatment-related complications, and enhance recovery. Studies suggest that a combination of exercise and psychological support before starting cancer treatment can lead to better outcomes than usual care. ^{1 2 3 4 5}

Is prehabilitation safe for cancer patients?

Prehabilitation, which includes exercise, psychological, and nutrition-based interventions, is generally considered safe for cancer patients. It aims to improve health and function before treatment, and there is growing evidence supporting its safety and benefits in enhancing recovery and reducing treatment-related complications. ^{1 2 5 6 7}

How is the prehabilitation treatment for cancer different from other treatments?

Prehabilitation for cancer is unique because it focuses on improving a patient's physical and psychological health before starting cancer treatment. This approach aims to enhance the patient's ability to handle the stress of treatment, potentially leading to better outcomes and fewer complications compared to starting treatment without this preparation. ^{1 5 6 8 9}

Research Team

Christopher E. Jensen

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Prehabilitation. An Interdisciplinary Patient-Centric Conceptual Framework. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

An international review and meta-analysis of prehabilitation compared to usual care for cancer patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Role and Scope of Prehabilitation in Cancer Care. [2021]

5. Italy pubmed.ncbi.nlm.nih.gov

Prehabilitation is the Gateway to Better Functional Outcomes for Individuals with Cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The impact of prehabilitation interventions on affective and functional outcomes for young to midlife adult cancer patients: A systematic review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Prehabilitation for adults diagnosed with cancer: A systematic review of long-term physical function, nutrition and patient-reported outcomes. [2020]

8. Scotland pubmed.ncbi.nlm.nih.gov

Prehabilitation services for people diagnosed with cancer in Scotland - Current practice, barriers and challenges to implementation. [2022]

9. India pubmed.ncbi.nlm.nih.gov

Exercise prehabilitation program for patients under neoadjuvant treatment for rectal cancer: A pilot study. [2022]