Reducing Sedentary Time for Leukemia

(ReSeT in ALL Trial)

Overseen By Brittany J Van Remortel, MD, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Must be taking: Maintenance chemotherapy

Disqualifiers: Recurrent disease, Pregnancy, Imprisonment, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help adolescents and young adults with acute lymphoblastic leukemia (ALL) undergoing maintenance chemotherapy reduce their sedentary time, which is time spent sitting or lying down without activity. Participants will use a fitness tracker that reminds them to move, engage in coaching sessions, and join a peer support group. These activities form part of the sedentary time intervention to determine if they encourage more activity. Researchers aim to discover whether this program not only reduces sedentary time but also improves quality of life and health markers like inflammation and metabolism. Those sitting for 4+ hours a day during leisure time and undergoing maintenance chemotherapy for ALL might find this trial suitable. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance the well-being of others in similar situations.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It focuses on reducing sedentary time for those receiving maintenance chemotherapy.

What prior data suggests that this mobile health intervention is safe for adolescents and young adults with acute lymphoblastic leukemia?

Research has shown that using a fitness tracker with reminders to move is generally easy and safe. In past studies, people used these devices without major problems. For example, one study found that participants regularly walked more than 10,000 steps each week with a fitness tracker, suggesting these devices are safe and easy to use.

Additionally, other studies have used mobile health tools like apps and fitness trackers without serious side effects. These tools help people become more active and have been safely used by various groups, including those with cancer.

Overall, research indicates that using a fitness tracker with reminders to move does not pose significant safety risks. Participants in these studies usually find the devices helpful in increasing their activity levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the sedentary time intervention for leukemia patients because it focuses on a novel approach: reducing inactivity. Unlike traditional treatments for leukemia, which primarily involve chemotherapy, radiation, or targeted therapy, this intervention aims to improve patient outcomes by encouraging more physical activity. This method could enhance patients' overall health and quality of life, potentially reducing fatigue and improving mental well-being. By shifting focus from medication to lifestyle changes, it opens new avenues for supportive care in leukemia treatment.

What evidence suggests that this mobile health intervention is effective for reducing sedentary time in adolescents and young adults with acute lymphoblastic leukemia?

Research shows that wearable fitness trackers can help people sit less. Previous studies have indicated that these devices motivate people to move more, improving their health. One study found that fitness trackers helped children with acute lymphoblastic leukemia (ALL) become more active and feel less tired. Another review demonstrated that these trackers effectively increase physical activity and improve health in cancer patients. In this trial, participants will receive a sedentary time intervention, which includes a fitness tracker, reminders, coaching, and support from others, to help young people with ALL sit less and feel better. ^{4 6 7 8 9}

Who Is on the Research Team?

Brittany J Ivory (Van Remortel), MD, MPH

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-18 with acute lymphoblastic leukemia who are sedentary, spending on average 8+ hours a day sitting or lying down. They must have completed at least one cycle of maintenance chemotherapy and be willing to reduce their sedentary time. Participants need internet access, a smartphone compatible with Fitbit and WhatsApp, and speak English fluently.

Inclusion Criteria

You spend most of your day sitting or lying down.

Are willing to spend less time sitting.

I have finished one cycle of maintenance chemotherapy and have at least one more to go.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a multi-component mobile health intervention including a wearable fitness tracker, individualized coaching sessions, and an app-based peer support group to decrease sedentary time over 10 weeks.

10 weeks

In-person visits coincide with Oncology clinic visits for maintenance chemotherapy

Follow-up

Participants are monitored for changes in sedentary time, quality of life, and metabolic markers post-intervention.

2 weeks

1 visit (in-person) for final assessments

What Are the Treatments Tested in This Trial?

Interventions

• Sedentary time intervention

Trial Overview The study tests if a mobile health intervention can decrease sedentary time in teens with ALL during maintenance chemotherapy. It includes using a fitness tracker with move reminders, coaching sessions, and an app-based support group over 10 weeks while monitoring quality of life and health changes.

How Is the Trial Designed?

Group I: Sedentary time intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

St. Baldrick's Foundation

Collaborator

Trials

19

Recruited

9,100+

Rally Foundation for Childhood Cancer Research

Collaborator

Trials

6

Recruited

500+

Published Research Related to This Trial

The study involving 86 participants found that self-reported sitting time using three different questionnaires showed weak correlations with data from thigh-worn accelerometers, indicating poor validity of self-reports.

Only about half of the participants accurately reported their sitting time, highlighting the need for sensor-based measurements to better assess sedentary behavior in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of Three Survey Questions for Self-Assessed Sedentary Time. Wahlström, V., Nygren, M., Olsson, D., et al.[2022]

A review of 42 studies found that hospitalized patients with acute illnesses are extremely sedentary, spending between 93% to 98.8% of their hospital stay inactive, and averaging less than 1,000 steps per day.

The study highlights the need for more research on sedentary behavior patterns in hospitalized patients, as current data primarily focuses on physical activity, with no studies reporting on sedentary bouts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerometry Shows Inpatients With Acute Medical or Surgical Conditions Spend Little Time Upright and Are Highly Sedentary: Systematic Review. Baldwin, C., van Kessel, G., Phillips, A., et al.[2022]

Survivors of childhood acute lymphoblastic leukemia (ALL) spend about 65% of their time being sedentary, which is linked to a decrease in lean body mass and an increased risk of cardiovascular disease (CVD) risk factors.

Specifically, those who are sedentary for 60% or more of the day have a significantly higher risk of developing high total cholesterol and other CVD risk factors, highlighting the importance of reducing sedentary behavior in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of sedentary behaviors in adult survivors of acute lymphoblastic leukemia: A report from the St. Jude Lifetime Cohort study. Howell, CR., Wilson, CL., Ehrhardt, MJ., et al.[2021]

A review of 26 studies found that interventions aimed at reducing sedentary behavior in adults were categorized as very promising (39%), quite promising (21%), and non-promising (39%), with worksite-based interventions being the most common.

The most effective strategies included environmental restructuring and self-monitoring techniques, suggesting that future interventions should focus on modifying environments and enhancing self-regulatory skills to reduce sedentary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to reduce sitting time? A review of behaviour change strategies used in sedentary behaviour reduction interventions among adults. Gardner, B., Smith, L., Lorencatto, F., et al.[2023]

The individualized motivational counseling intervention led to a decrease in sitting time by an average of 0.27 hours per day among participants, although this change was not statistically significant compared to the control group.

Participants in the intervention group showed significant improvements in cardiometabolic health markers, including a reduction in fasting serum insulin, insulin resistance, and waist circumference, suggesting potential health benefits despite the lack of a significant reduction in sitting time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational counseling to reduce sitting time: a community-based randomized controlled trial in adults. Aadahl, M., Linneberg, A., Møller, TC., et al.[2018]

A systematic review of nine studies involving 394 cancer patients or survivors found that interventions aimed at reducing sedentary behaviors (SB) showed promise, with participants often reducing SB and increasing moderate-to-vigorous physical activity.

Most studies focused on feasibility and utilized wearable devices to encourage behavior change, but there is a need for more high-quality randomized controlled trials to better understand effective strategies for reducing SB in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Reduce Sedentary Behavior in Cancer Patients and Survivors: a Systematic Review. Belcher, BR., Kang, DW., Yunker, AG., et al.[2023]

A systematic review of 15 studies involving 4588 participants in Germany found inconsistent evidence on the effectiveness of interventions aimed at reducing sedentary behavior in both children and adults, with many studies showing no significant effects.

The meta-analysis specifically indicated that children in both control and intervention groups actually increased their sedentary time, suggesting a need for more effective strategies, such as family-involved physical and social environment interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Interventions to Reduce Sedentary Time in Different Target Groups and Settings in Germany: Systematic Review, Meta-Analysis and Recommendations on Interventions. Mugler, N., Baurecht, H., Lam, K., et al.[2022]

Adult survivors of childhood acute lymphoblastic leukemia (ASALL) show similar levels of physical activity and sedentary behavior compared to healthy peers, indicating that they maintain comparable movement patterns despite their medical history.

Both ASALL and healthy control groups met the health recommendations for physical activity, suggesting that physical activity may play a role in managing late effects of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerometry-based assessment of physical activity and sedentary behavior in adult survivors of childhood acute lymphoblastic leukemia and their healthy peers. Vyhlídal, T., Dygrýn, J., Hrubá, J., et al.[2023]

A study involving 18 full-time employees showed that using a pedal exercise machine at work for 4 weeks was feasible and led to a reported decrease in sedentary time, with participants using the machines on average 12.2 days and pedalling for about 23.4 minutes each day they used it.

The results suggest that pedal machines could be an effective tool for reducing sedentary behavior in the workplace, which is important for improving employee health in increasingly sedentary jobs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a portable pedal exercise machine for reducing sedentary time in the workplace. Carr, LJ., Walaska, KA., Marcus, BH.[2022]

Sedentary behavior is recognized as a significant risk factor for health issues, particularly in obese individuals, highlighting the need for targeted interventions to reduce sitting time.

Effective strategies to combat sedentary behavior include breaking up long periods of sitting with light activity and using new technologies to both measure and promote these changes in daily routines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sedentary behavior: target for change, challenge to assess. Rosenberger, M.[2021]

A pilot study involving 41 hematologic malignancy survivors showed that a 16-week mHealth-supported intervention, which included individualized goal-setting and peer support via Facebook, was feasible and well-accepted, with a high participant retention rate of 90.2%.

While the intervention did not yield statistically significant differences in activity or dietary outcomes compared to the control group, it was associated with improvements in dietary factors and physical activity levels, indicating potential benefits for cardiovascular risk reduction in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a behavioral intervention using mobile health applications to reduce cardiovascular risk factors in cancer survivors: a pilot randomized controlled trial. Chow, EJ., Doody, DR., Di, C., et al.[2022]

A review of 12 studies involving 517 children and adolescents with cancer found that interventions using activity trackers can lead to improvements in physical activity levels and health outcomes, such as aerobic fitness and mood.

While only 2 out of the 12 studies reported increased physical activity, the overall findings suggest that wearable activity trackers may positively impact health in pediatric oncology, highlighting the need for further research to optimize their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Activity Trackers in Interventions for Childhood Cancer Patients and Survivors: A Systematic Review. Ha, L., Mizrahi, D., Wakefield, CE., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06182163

Reduce Sedentary Time in Acute Lymphoblastic Leukemia The goal of this feasibility trial is to test if a mobile health intervention, including a wearable fitness tracker with inactivity-triggered reminders to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9834757/

Effect of an mHealth Intervention on Physical Activity ... Given evidence that high levels of sedentary behavior are associated with poor health outcomes in cancer survivors, future research should focus on reducing ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9068515/

Effect and feasibility of wearable physical activity trackers ... Supervised exercise interventions have been shown to be effective for increasing physical activity levels and improving health outcomes in cancer populations.

4. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(24)00139-0/fulltext

Effect of wearable activity trackers on physical activity in ... A scoping review of wearable activity monitors in interventions targeting physical activity, sedentary behavior, and sleep

5. researchgate.net researchgate.net/publication/290378647_Use_of_a_Fitness_Tracker_to_Promote_Physical_Activity_in_Children_With_Acute_Lymphoblastic_Leukemia

Use of a Fitness Tracker to Promote Physical Activity in ... In Hooke's study, FitBit fitness tracker was used to monitoring activity and relieve the fatigue in children diagnosed with Acute Lymphoblastic Leukaemia (Hooke ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06182163

Reduce Sedentary Time in Acute Lymphoblastic Leukemia The goal of this feasibility trial is to test if a mobile health intervention, including a wearable fitness tracker with inactivity-triggered reminders to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8198944/

mHealth Interventions to Address Physical Activity and ... Overall, only four studies reported a significant decrease in SB following an mHealth intervention. Two controlled trials that used activity trackers with apps ...

8. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.34556

Effect of an mHealth intervention on physical activity outcomes ... Current guidelines recommend that cancer survivors avoid inactivity and engage in both aerobic and resistance-based physical activity (PA) to ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT07042932

Online Physical Activity and Health Counseling for ... Advances in the medical treatment of childhood acute lymphoblastic leukemia (ALL) have resulted in 5-year survival rates above 90%- however, the success is ...