Tailored Exercise Program for Cancer Patients

(PALS Trial)

Recruiting at 1 trial location

Overseen By Pamela J. Grizzard

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Uncontrolled hypertension, Alcohol abuse, Lupus, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine whether a tailored exercise program or health workshops can help cancer patients maintain physical, heart, and brain health, as well as overall quality of life during treatment. Participants will be randomly assigned to either attend health workshops focused on nutrition and stress management or engage in regular, guided exercise sessions as part of a tailored physical activity intervention. Individuals diagnosed with stage I-IV Hodgkin's or non-Hodgkin's lymphoma or stage I-III breast cancer, who are undergoing specific cancer treatments, may be eligible to join. As an unphased trial, this study offers a unique opportunity to explore supportive care options that may enhance well-being during cancer 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that exercise is safe and beneficial for people with cancer. Studies have found that exercise can reduce the severity of side effects from cancer treatments, decrease tiredness, and improve overall quality of life. Additionally, staying active during and after cancer treatment is safe for young adults and teenagers with cancer. Exercise not only lowers the risk of negative effects but also enhances well-being and health. For those considering joining a trial with a personalized exercise program, evidence suggests it is well-tolerated and offers several benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the tailored exercise program for cancer patients because it offers a personalized approach to support recovery and improve quality of life. Unlike standard care, which often involves generic advice on physical activity, this intervention uses the Trainerize app to deliver customized exercise plans that patients can follow both at home and with a trainer. Participants can attend one to two training sessions per week, plus additional home sessions, creating a flexible and supportive environment that adapts to their unique needs. This tailored program is designed to empower patients, potentially offering better adherence and outcomes compared to standard exercise recommendations.

What evidence suggests that this trial's treatments could be effective for cancer patients?

Research has shown that exercise can greatly benefit cancer patients. In this trial, participants may receive a Tailored Physical Activity Intervention, which involves personalized exercise programs to help increase activity levels. Studies have found that such programs benefit patients with cancers like prostate and colorectal cancer. Specifically, one study discovered that breast cancer patients who joined a similar program improved their walking and overall activity within three months. Additionally, structured exercise programs are linked to better chances of staying disease-free compared to just receiving health advice. Exercise also helps reduce side effects and boosts well-being for people with cancer. ^{5 6 7 8 9}

Who Is on the Research Team?

William Hundley, MD

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Tailored Physical Activity 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.

How Is the Trial Designed?

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Exercise interventions significantly improve upper body muscle strength (UBMS), lower body muscle strength (LBMS), lower body muscle function (LBMF), and aerobic fitness in cancer patients, with larger effects observed in supervised programs.

Factors such as age, marital status, frequency and type of exercise, and timing of the intervention influence the effectiveness of exercise, indicating that personalized exercise plans may enhance benefits for patients undergoing cancer treatment.

NCBI (Pubmed)

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. Sweegers, MG., Altenburg, TM., Brug, J., et al.[2022]

Tailored exercise classes significantly improved physical fitness and coping mechanisms among 25 breast cancer survivors, helping them overcome barriers to exercise due to altered physical appearance and fitness levels.

Participants valued the peer support from the group, which fostered psychological well-being and a sense of normality, ultimately leading to improved self-esteem and a greater sense of mastery over their cancer experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of breast cancer survivors participating in a tailored exercise intervention -a qualitative study. Luoma, ML., Hakamies-Blomqvist, L., Blomqvist, C., et al.[2015]

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]

Exercise has been shown to improve various outcomes for cancer patients, including reducing fatigue, enhancing quality of life, and potentially increasing survival rates, yet many oncologists remain hesitant to prescribe it due to concerns about patient tolerance and understanding of its benefits.

International guidelines now recommend that healthcare providers counsel cancer patients on healthy lifestyle changes, including exercise, but there is still a need to overcome barriers and increase awareness among both patients and physicians to integrate exercise into cancer care effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise oncology: an emerging discipline in the cancer care continuum. Watson, G., Coyne, Z., Houlihan, E., et al.[2022]

The EFICANCER individualized exercise program significantly improved cancer-specific quality of life and functional capacity in patients with stage IV gastrointestinal, breast, or non-small cell lung cancer, with a notable difference of 15.7 points in quality of life scores after 12 months.

The program was found to be safe and feasible, with 74.47% of participants completing at least one session, highlighting its potential as a valuable addition to standard oncological care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Supervised Exercise for People with Stage IV Cancer: The EFICANCER Randomized Clinical Trial. Mendizabal-Gallastegui, N., Arietaleanizbeaskoa, MS., Latorre, PM., et al.[2023]

Exercise is both safe and effective for individuals living with and beyond breast cancer, yet many do not engage in or maintain recommended exercise levels, indicating a gap between research findings and real-world application.

The paper suggests implementing exercise screening and referral pathways to improve access to tailored exercise programs that address specific breast cancer-related impairments, which could enhance participation in exercise oncology resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailoring the Evidence for Exercise Oncology within Breast Cancer Care. Wagoner, CW., Capozzi, LC., Culos-Reed, SN.[2022]

Engaging in 150 minutes of moderate aerobic activity per week can significantly enhance the quality of life for cancer patients, improving survival rates and reducing treatment side effects.

The National Cancer Institute in Aviano has implemented a personalized rehabilitation program for breast cancer patients that combines medical care with physical activity, utilizing a mobile app to support and encourage exercise during and after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-breast cancer coaching: the synergy between health and fitness through co-production. Biancuzzi, H., Miceli, L., Bednarova, R., et al.[2020]

A home-based exercise program for patients with multiple myeloma showed a high adherence rate of 75% over six months, indicating that such programs can be feasible even during intensive treatments like chemotherapy.

Patients who participated in the exercise program demonstrated improvements in physical performance, while those in the usual-care group experienced declines, highlighting the potential benefits of exercise for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating exercise adherence for patients with multiple myeloma. Coleman, EA., Hall-Barrow, J., Coon, S., et al.[2008]

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]

This pilot study will assess the feasibility of personalized virtual exercise training for 20 breast and prostate cancer survivors over 24 weeks, which includes 12 weeks of one-on-one training followed by 12 weeks of independent exercise using recorded sessions.

The study aims to evaluate the preliminary effects of this virtual program on various health metrics, such as body composition and exercise self-efficacy, potentially addressing barriers to physical activity in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Streaming Web-Based Exercise at Home Study for Breast and Prostate Cancer Survivors: A Feasibility Study Protocol. Shirazipour, CH., Ruggieri-Bacani, RM., Lockshon, L., et al.[2023]

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]

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