Exercise Intervention for Young Cancer Survivors

Overseen By Maxime Caru, PhD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Refractory cancer, Recurrence, Others

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

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding exercise to usual post-cancer care can help young cancer survivors manage pain and improve overall well-being. Participants will either continue with standard post-cancer treatment or join a physical activity program to assess whether exercise reduces their need for pain medication and enhances quality of life. The trial targets cancer survivors aged 18 to 39 who completed treatment within the last year and experience chronic pain. As an unphased trial, it offers a unique opportunity for participants to contribute to understanding the benefits of exercise in enhancing recovery and quality of life.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems the focus is on integrating exercise into your care, so you may not need to stop your medications, but it's best to discuss this with the trial coordinators.

What prior data suggests that this exercise intervention is safe for young cancer survivors?

Research shows that exercise is safe and beneficial for young cancer survivors. Studies indicate that most individuals can engage in physical activity during and after cancer treatments without serious issues.

For teens and young adults who have had cancer, exercise can enhance health and well-being. It helps manage pain and improves physical and emotional well-being. Reports have not indicated major harm from exercise in this group.

In summary, evidence suggests that physical activity is a safe way for young cancer survivors to improve well-being and manage pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise intervention for young cancer survivors because it focuses on enhancing recovery and long-term health through physical activity, a method not typically emphasized in standard post-cancer care. Traditional treatments for cancer survivors often involve medical follow-ups and medications, but this intervention adds a proactive lifestyle component. This approach aims to improve physical fitness, mental well-being, and overall quality of life by encouraging regular physical activity, which can be empowering for young survivors. By integrating this with standard care, the intervention hopes to offer a more holistic recovery strategy, potentially reducing long-term health risks and improving survivors' everyday experiences.

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

Research shows that exercise programs offer many benefits for young cancer survivors. Studies have found that these programs can increase weekly step counts, lower body weight and BMI, and reduce pain. Participants often feel better about their physical activity levels and experience higher self-esteem, enhancing their quality of life during and after treatment. Despite these benefits, many young adult cancer survivors still do not get enough exercise, indicating that exercise programs could significantly impact their well-being. In this trial, one group will receive a physical activity intervention alongside standard post-cancer treatment care, while another group will receive only the standard care. Overall, incorporating physical activity into post-cancer care can help manage pain and improve bodily function. ^{1 4 6 7 8}

Who Is on the Research Team?

Smita Dandekar, MD

Principal Investigator

Penn State College of Medicine

Are You a Good Fit for This Trial?

This trial is for Adolescent and Young Adult (AYA) cancer survivors, aged 17-39, who are less than a year post-cancer therapy. They must speak English, be stable post-treatment, able to consent and attend three visits at Penn State Health Milton S. Hershey Medical Center. Participants with chronic pain and access to wifi-enabled devices can join; those over a year post-therapy or with contraindications to exercise cannot.

Inclusion Criteria

I am a young adult cancer survivor, able or unable to walk.

I am a young cancer survivor with chronic pain rated at least 1 out of 10, lasting over 3 months.

AYA cancer survivors must be able to speak, read and understand the English language

Exclusion Criteria

I am a young adult cancer survivor who cannot speak, read, or understand English.

Cancer survivors who have evidence of an absolute contraindication to complete any of the physical assessments in their medical record. This exclusion criterion is at the oncologist's discretion when research staff will contact the medical oncologist via secure email or secure message through the electronic medical record for approval to approach their patients for the study and for medical clearance. The oncologists can update this information at any time during the study if there is evidence of an absolute contraindication to complete any of the physical assessments

I am a cancer survivor under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments including psychosocial questionnaires, physical activity level, and functional outcomes

1 week

1 visit (in-person)

Treatment

Participants receive physical activity intervention coupled with standard post-cancer directed treatment care

16 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for changes in pain levels, physical activity, and functional outcomes

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Physical activity intervention
• Standard post-cancer directed treatment care

Trial Overview

The study tests if adding an exercise program to standard care after cancer treatment helps reduce pain without the need for medication in AYA survivors compared to standard care alone. It aims to see if this approach is practical and improves functional and psychosocial outcomes.

How Is the Trial Designed?

Group I: Standard post-cancer directed treatment care control group Experimental Treatment 1 Intervention

Group II: Physical activity intervention coupled with standard post-cancer directed treatment care group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

Exercise interventions during and after chemotherapy for patients with hematological cancer are generally reported as safe and feasible, based on a systematic review of 12 studies, including six randomized controlled trials.

Despite the positive claims about safety and feasibility, many studies lack detailed information on how these conclusions were reached, highlighting the need for more comprehensive reporting in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exercise interventions in patients with hematological cancer undergoing chemotherapy: a systematic review. Großek, A., Großek, K., Bloch, W.[2023]

The mHealth physical activity intervention did not significantly increase accelerometer-measured total physical activity compared to a self-help group over 12 months, but it did lead to greater self-reported physical activity in participants.

At the 12-month mark, a higher percentage of participants in the intervention group reported meeting national physical activity guidelines compared to the self-help group (47.9% vs. 33.1%), indicating potential benefits of digital approaches for promoting sustained physical activity in young adult cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity maintenance among young adult cancer survivors in an mHealth intervention: Twelve-month outcomes from the IMPACT randomized controlled trial. Valle, CG., Diamond, MA., Heiling, HM., et al.[2023]

Physical activity has been shown to significantly improve both patient-reported outcomes and physiological health in cancer survivors during and after treatment, highlighting its importance in recovery.

The review discusses ongoing phase III trials that are investigating the impact of physical activity on clinical disease endpoints, suggesting a strong focus on integrating exercise into cancer care to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting Exercise Into Oncology Practice: State-of-the-Science, Innovation, and Future Directions. Brown, JC., Ligibel, JA.[2023]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10877394/

Physical Activity Intervention Characteristics and Effects on ...

These improved outcomes included increased weekly steps, decreased BMI and body weight, increased moderate-to-vigorous intensity PA (MVPA)/week, reduced pain ...

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sciencedirect.com

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Promoting physical activity in young adult cancer survivors ...

Despite the health benefits of physical activity for cancer survivors, nearly 60% of young adult cancer survivors (YACS) are physically inactive.

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Effect of an mHealth intervention on physical activity outcomes ...

Young adult cancer survivors participating in a mobile health intervention did not significantly increase accelerometer-measured total ...

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Secondary outcomes were physical activity levels, self-efficacy and quality of life at 12 months. Data collection was conducted at baseline, 6 and 12 months ...

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The effects of physical activity interventions on self-esteem ...

For mind-body exercise interventions, our results suggest a positive effect on improving self-esteem during and after cancer treatment.

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mHealth Physical Activity Intervention for Young Cancer ...

The main goal of this study is to see if a home-based, mobile health (mHealth) physical activity intervention can increase physical activity levels by at least ...

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nature.com

nature.com/articles/s41416-024-02748-x

The Physical Activity and Cancer Control (PACC) framework

The 2019 ACSM updated exercise guidelines for cancer survivors stated that exercise training was generally safe and well tolerated during and ...

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oncologynurseadvisor.com

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Identifying Effective Physical Activity Interventions for AYA ...

These studies reported at least 1 statistically significant behavioral or health outcome. The outcomes included increased peak VO2, reduced ...