Tailored Exercise Program for Cancer Patients

(PALS Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by William Hundley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Uncontrolled hypertension, Alcohol abuse, Lupus, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests whether exercise sessions or health workshops can help cancer patients maintain their fitness, heart function, memory, and quality of life during treatment.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves exercise and educational workshops, it is likely that you can continue your medications. It's best to discuss this with your doctor and the trial coordinators.

What data supports the idea that Tailored Exercise Program for Cancer Patients is an effective treatment?

The available research shows that tailored exercise programs for cancer patients can significantly improve their quality of life. For example, studies have found that exercise helps reduce fatigue and depression, which are common side effects of cancer treatment. In one study, patients with multiple myeloma who followed a home-based exercise program showed improvements in physical performance, while those who did not exercise experienced declines. Another study highlighted that 150 minutes of moderate aerobic activity per week can enhance survival rates and reduce treatment side effects. Overall, these findings suggest that exercise is a valuable part of cancer care, offering benefits that are comparable to other treatments. ^{1 2 3 4 5}

What safety data exists for tailored exercise programs for cancer patients?

The research indicates that exercise is generally safe and beneficial for cancer patients, including those with breast, prostate, colorectal, and lung cancer. Studies highlight the efficacy and safety of tailored exercise interventions, such as computer-tailored and virtual exercise programs, for improving physical and psychological outcomes. However, there is a need for more extensive research on tailoring exercise to address specific cancer-related impairments to ensure safe participation. ^{6 7 8 9 10}

Is the Tailored Physical Activity Intervention a promising treatment for cancer patients?

Yes, the Tailored Physical Activity Intervention is a promising treatment for cancer patients. It improves quality of life, helps with recovery, and can increase survival rates. Exercise is now seen as an important part of cancer care, similar to medical treatments. ^{2 4 11 12 13}

Research Team

William Hundley, MD

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults aged 18-85 with Hodgkin's or non-Hodgkin's lymphoma who can walk two city blocks and are expected to undergo certain cancer therapies. They must speak English, have a survival expectancy beyond 6 months, and an assistant for home-based activities. Exclusions include uncontrolled high blood pressure, MRI contraindications, recent heart attack, inability to exercise on treadmill/cycle, pregnancy, drug abuse history, inflammatory conditions or other safety-compromising medical issues.

Inclusion Criteria

I can walk at least 2 city blocks without assistance.

I have been diagnosed with Hodgkin's or non-Hodgkin's lymphoma at any stage.

Ability to speak and understand English

Exclusion Criteria

I have atrial fibrillation with a fast heart rate that isn't well-controlled.

Claustrophobia

Contraindications to MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices (unless approved by the participant's physician and the Principal Investigator)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either a Physical Activity Intervention or a Healthy Living Intervention for 6 months

6 months

Weekly visits for the first month, biweekly for 3 months, and monthly for the last 2 months

Follow-up

Participants are monitored for changes in exercise capacity, heart function, and quality of life

3 months

Treatment Details

Interventions

• Tailored Physical Activity Intervention (Behavioural Intervention)

Trial Overview The study compares the effects of a physical activity program using Trainerize app and educational workshops on preserving exercise capacity during cancer treatment. Participants will be randomly assigned to either attend health workshops focusing on lifestyle education or engage in moderate physical activities remotely or in person throughout their treatment.

Participant Groups

Group I: Physical Activity Intervention Experimental Treatment 6 Interventions

Participants will have the ability to attend one to two training sessions per week and 1-2 sessions per week at home (the 4th level of our multi-level intervention) or the location site using the Trainerize application to deliver the exercise prescription.

Group II: Healthy Living Intervention (Control Arm) Experimental Treatment 5 Interventions

Participants randomized to the control arm will participate in organized health workshops. Each session will last 60 minutes and will be offered on location and virtually (e.g., Zoom) over 6 months. Participants will meet once a week for the first 4 weeks, biweekly for 3 months, and once a month for the last 2 months for a total of 12 sessions.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

Physical activity and targeted exercise therapy can significantly improve outcomes for cancer patients, helping to manage side effects like fatigue and depression, especially when introduced right after diagnosis.

Moderate endurance training combined with individualized strength training is particularly effective and can be recommended for all cancer patients, regardless of cancer type, while ensuring contraindications are considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical activity and exercise therapy in oncology]. Zoth, N., Böhlke, L., Theurich, S., et al.[2023]

A study of 350 cancer patients receiving physical therapist-led exercise counseling showed significant reductions in global distress and fatigue, indicating that exercise counseling can effectively improve symptoms related to cancer treatment.

Patients reported notable improvements in overall health and well-being after counseling, suggesting that exercise may play a crucial role in enhancing quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapist-Led Exercise Assessment and Counseling in Integrative Cancer Care: Effects on Patient Self-reported Symptoms and Quality of Life. Lopez, G., Eddy, C., Liu, W., et al.[2023]

The OncoActive intervention, which included a pedometer and computer-tailored physical activity advice, significantly increased self-reported physical activity among prostate and colorectal cancer survivors, with improvements noted at both 3 and 6 months after the intervention.

Participants in the OncoActive group also experienced significant improvements in physical functioning, fatigue, and depression, particularly among colorectal cancer survivors, indicating that tailored interventions can enhance recovery and quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term efficacy of a computer-tailored physical activity intervention for prostate and colorectal cancer patients and survivors: a randomized controlled trial. Golsteijn, RHJ., Bolman, C., Volders, E., et al.[2018]

Exercise interventions for lung cancer patients significantly reduce post-operative complications and improve exercise capacity, based on a systematic review of 30 studies involving a total of 6440 participants.

While exercise showed benefits in pre- and post-operative settings, health-related quality of life improvements were mostly non-significant, indicating a need for further high-quality research, especially in non-surgical populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise across the Lung Cancer Care Continuum: An Overview of Systematic Reviews. Edbrooke, L., Bowman, A., Granger, CL., et al.[2023]

An interventional exercise program for cancer patients was designed to enhance self-confidence and improve quality of life, focusing on cardiovascular function, metabolism, muscular strength, endurance, and flexibility.

The program included both body and mind fitness components, which are crucial for balance and overall recovery after cancer therapy, highlighting the importance of physical activity in post-cancer rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intervention Exercise Program for Cancer Patients with Breast Cancer]. Pokorná, A., Střeštíková, R.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Physical activity and exercise therapy in oncology]. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effects and moderators of exercise on muscle strength, muscle function and aerobic fitness in patients with cancer: a meta-analysis of individual patient data. [2022]

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

Facilitating exercise adherence for patients with multiple myeloma. [2008]

4. Italy pubmed.ncbi.nlm.nih.gov

Post-breast cancer coaching: the synergy between health and fitness through co-production. [2020]

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

Physical Therapist-Led Exercise Assessment and Counseling in Integrative Cancer Care: Effects on Patient Self-reported Symptoms and Quality of Life. [2023]

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

Short-term efficacy of a computer-tailored physical activity intervention for prostate and colorectal cancer patients and survivors: a randomized controlled trial. [2018]

7. Greece pubmed.ncbi.nlm.nih.gov

Experiences of breast cancer survivors participating in a tailored exercise intervention -a qualitative study. [2015]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Streaming Web-Based Exercise at Home Study for Breast and Prostate Cancer Survivors: A Feasibility Study Protocol. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise across the Lung Cancer Care Continuum: An Overview of Systematic Reviews. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Tailoring the Evidence for Exercise Oncology within Breast Cancer Care. [2022]

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

Nurse-Supervised Exercise for People with Stage IV Cancer: The EFICANCER Randomized Clinical Trial. [2023]

12. Czech Republic pubmed.ncbi.nlm.nih.gov

[Intervention Exercise Program for Cancer Patients with Breast Cancer]. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Exercise oncology: an emerging discipline in the cancer care continuum. [2022]