Tailored Exercise Program for Childhood Cancer Survivors with Limited Mobility

Overseen By Kirsten K. Ness

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Pregnancy, Psychological distress, Heart failure, others

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

Compensation: Varies

Number of Visits: 9

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a personalized exercise program can help childhood cancer survivors become more active, particularly those who struggle with exercise due to past treatments. Researchers seek to understand if these tailored exercises can enhance heart, lung, muscle, and nerve function, as well as emotional health and overall quality of life. Participants will be divided into two groups: one receiving a personalized exercise plan and the other receiving general exercise advice, both for 20 weeks. This trial is ideal for SJLIFE study participants who find exercising difficult and have internet access. As an unphased trial, it offers a unique opportunity for participants to contribute to research that could improve exercise programs for childhood cancer survivors.

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 exercise program is safe for childhood cancer survivors?

Research has shown that exercise programs for children who have survived cancer are generally safe. Studies indicate that regular physical activity can boost fitness and help manage long-term effects from past cancer treatments. For example, one study found that participants experienced benefits like improved physical fitness.

Customized exercise programs that meet individual needs and abilities can be particularly effective. This personalized approach ensures the exercise is suitable for each person, making it safer and more enjoyable.

In summary, while childhood cancer survivors usually tolerate exercise well, it's important that the program is tailored to fit personal health needs. This ensures the exercise is both safe and beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the tailored exercise program for childhood cancer survivors with limited mobility because it offers a personalized approach. Unlike generalized exercise recommendations, this program is individually tailored and supervised, potentially providing more effective support and improvement in mobility and strength. This personalized attention could lead to better long-term health outcomes and quality of life for survivors, making it a promising option compared to standard physical therapy or unsupervised exercise plans.

What evidence suggests that this exercise program is effective for childhood cancer survivors with exercise intolerance?

Research shows that exercise can help childhood cancer survivors improve their physical abilities and fitness. Exercise programs specifically designed for these young patients have successfully maintained or enhanced their physical function. Studies have found that regular physical activity can also reduce long-term issues, such as exercise difficulties, that survivors often face. In this trial, participants in the Personalized exercise group (INTGroup) will receive an individually tailored exercise program, potentially helping survivors become more active and healthier overall. Meanwhile, the Generalized exercise group, Attention Control (AC Group), will receive generalized exercise recommendations. Early findings suggest that personalized exercise plans may also boost emotional well-being and quality of life. ^{1 3 6 7 8}

Who Is on the Research Team?

Kirsten K. Ness

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for childhood cancer survivors aged 18-40 with limited exercise ability due to past treatments. They must understand how to use ZOOM and a heart rate monitor, have internet access, and get clearance from a study doctor. It's not for those in other exercise programs, very active individuals, pregnant women, or those needing urgent medical care.

Inclusion Criteria

You are a participant in the SJLIFE study.

You need to have access to the internet.

Clearance for participation in exercise by a study physician

Exclusion Criteria

Research Participant Recruitment and Screening

I need urgent treatment for a serious heart condition.

I am experiencing severe emotional distress.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an individually tailored, home-delivered aerobic and strengthening intervention or generalized exercise recommendations

20 weeks

3 visits (in-person) at baseline, 4 months, and 10 months

Follow-up

Participants are monitored for sustainability of exercise capacity improvements and other health measures

6 months

Follow-up assessments at 6 months after week 20

What Are the Treatments Tested in This Trial?

Interventions

• Individually tailored exercise program

Trial Overview

The study tests if a personalized home-based aerobic and strengthening program can improve physical capacity in these survivors. It also looks at the effects on heart, lung function, muscles, nerves, emotional health, social participation, life quality and thinking skills.

How Is the Trial Designed?

Group I: Personalized exercise group (INTGroup) Experimental Treatment 2 Interventions

Participants in this group have individually tailored exercise program with supervision, 20 weeks,clinic 3 times during the course of this study: at baseline (this appointment), at 4 months and 10 months from now for follow-up.

Group II: Generalized exercise group, Attention Control (AC Group) Experimental Treatment 2 Interventions

Study participants in this group receive generalized exercise recommendations, 20 weeks,clinic 3 times during the course of this study: at baseline (this appointment), at 4 months and 10 months from now for follow-up.

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The study is evaluating a tailored exercise intervention for childhood cancer survivors with exercise intolerance, involving 160 participants randomized into intervention and control groups over a 20-week period.

The intervention includes a personalized exercise plan delivered via telehealth, aiming to improve physical activity levels and overall health without the need for travel, which may enhance adherence and confidence in exercising.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and methods of a randomized telehealth-based intervention to improve fitness in survivors of childhood cancer with exercise intolerance. Maharaj, A., Jefferies, JL., Mulrooney, DA., et al.[2023]

A controlled clinical trial involving 28 children who survived brain tumors showed that exercise training significantly improved physical functioning, particularly in bilateral coordination, with benefits lasting up to 12 weeks after training ended.

Participants in group training settings also experienced increased cardiopulmonary fitness, as indicated by improved work rates, highlighting the effectiveness of structured exercise programs for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training improves physical function and fitness in long-term paediatric brain tumour survivors treated with cranial irradiation. Piscione, PJ., Bouffet, E., Timmons, B., et al.[2018]

Citations

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Tailored Exercise Program for Childhood Cancer Survivors ...

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The overall aim of the Physical Activity and Fitness in Childhood Cancer Survivors (PACCS) study is to address the abovementioned research gaps ...

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Participants reported almost exclusively positive experiences of participating in the program, which yielded benefits for the patients' physical fitness and ...