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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of this treatment for young cancer survivors?

Research shows that physical activity interventions are safe and beneficial for young cancer survivors, improving health-related outcomes like physical functioning and quality of life. Studies highlight the positive impact of personalized exercise plans, wearable devices, and goal setting in enhancing recovery and overall well-being. ^{1 2 3 4 5}

Is exercise intervention safe for young cancer survivors?

Exercise during and after cancer treatment is generally safe for young cancer survivors, with studies showing it can improve health outcomes. Only a few studies reported any exercise-related adverse events, suggesting that physical activity is typically well-tolerated in this group. ^{2 3 6 7 8}

How is the physical activity intervention treatment unique for young cancer survivors?

The physical activity intervention for young cancer survivors is unique because it is tailored to individual needs, often using wearable devices and goal setting to improve health outcomes. Unlike traditional treatments, it focuses on enhancing overall well-being and recovery through personalized exercise plans, which can help mitigate symptoms like fatigue and anxiety. ^{2 5 9 10 11}

What is the purpose of this trial?

The purpose of this study is to demonstrate that integration of exercise intervention into standard post-cancer directed treatment care will improve patient reported pain, decrease the need for medications to manage chronic pain and improve functional and psychosocial outcomes in survivors of cancers in adolescents and young adults (AYA). Our central hypothesis is that integration of exercise interventions into standard post-cancer directed treatment care will be acceptable and feasible while improving patients' pain, decreasing the cumulative dose of pain medication and improving patients' functional and psychosocial outcomes as compared to patients who only receive standard post-cancer directed treatment care.

Research Team

Smita Dandekar, MD

Principal Investigator

Penn State College of Medicine

Eligibility Criteria

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

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

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

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

Physical Activity Intervention Characteristics and Effects on Behavioral and Health-Related Outcomes Among Adolescents and Young Adults Living with and Beyond Cancer: A Systematic Review. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Physical activity interventions in pediatric, adolescent, and young adult cancer survivors: a systematic review. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A scoping review to map the evidence of physical activity interventions in post-treatment adolescent and young adult cancer survivors. [2022]

5. United States 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. [2023]

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

Engagement in Physical Activity Among Young Adult Childhood and Adolescent Cancer Survivors: Integration of Nature Technology. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exercise interventions in patients with hematological cancer undergoing chemotherapy: a systematic review. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

What are the effects of exercise training in childhood cancer survivors? A systematic review. [2020]

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

Expert Consensus on Physical Activity Use for Young Adult Cancer Survivors' Biopsychosocial Health: A Modified Delphi Study. [2022]

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

A survey of physical activity programming and counseling preferences in young-adult cancer survivors. [2015]

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

Effect of an mHealth intervention on physical activity outcomes among young adult cancer survivors: The IMPACT randomized controlled trial. [2023]