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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot clinical trial is to test if a mobile health intervention, including a wearable fitness tracker with inactivity-triggered reminders to move, individualized coaching sessions, and an app-based peer support group, can decrease sedentary time (time spent sitting/lying down and inactive) in adolescents and young adults (AYAs) with acute lymphoblastic leukemia (ALL) receiving maintenance chemotherapy. The main questions it aims to answer are: * Is the intervention a feasible and acceptable way to decrease sedentary time among adolescents and young adults (AYAs) with ALL? * Does the intervention show evidence that it may decrease sedentary time? * Does the intervention show evidence that it may increase quality of life, reduce inflammation, and improve glucose and lipid metabolism? Participants will use their fitness tracker with reminders to move as well as support from other intervention participants and coaching with study staff to gradually decrease their sedentary time over 10 weeks. Researchers will compare participant pre- and post-intervention study measures to see if the program may be helpful to decrease sedentary time in adolescents and young adults (AYAs) with ALL. All participants will wear an activity tracker on the thigh for 7 days at the beginning and end of the study as well as complete quality of life questionnaires. Study labs will be collected three times (baseline, 8 weeks, and 12 weeks) over the course of the 12-week study. All in-person study visits and labs will occur in conjunction with Oncology clinic visits for maintenance chemotherapy.

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 data supports the effectiveness of the treatment for reducing sedentary time in leukemia patients?

Research suggests that reducing sedentary behavior can improve health outcomes for cancer patients, and using wearable activity trackers has shown positive effects on physical activity and health in children with cancer. These findings indicate that similar interventions may help leukemia patients by encouraging more movement and reducing time spent sitting. ^{1 2 3 4 5}

Is reducing sedentary time safe for people with leukemia?

Research on reducing sedentary time in cancer patients suggests it is generally safe and may improve health outcomes. These interventions have been studied in various settings and are considered feasible for improving health by decreasing time spent sitting. ^{1 6 7 8 9}

How is the sedentary time intervention treatment for leukemia different from other treatments?

The sedentary time intervention for leukemia is unique because it focuses on reducing the time spent sitting or lying down, using tools like wearable fitness trackers and mobile health technology. Unlike traditional treatments that may focus on medication or chemotherapy, this approach aims to improve health by encouraging more movement and less sedentary behavior, which is a novel strategy for managing leukemia. ^{6 8 10 11 12}

Research Team

Brittany J Van Remortel, MD, MPH

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

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

I am between 12 and 18 years old.

You spend most of your day sitting or lying down.

Are willing to spend less time sitting.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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 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]

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 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]

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]

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 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]

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]

References

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

Interventions to Reduce Sedentary Behavior in Cancer Patients and Survivors: a Systematic Review. [2023]

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

The Use of Activity Trackers in Interventions for Childhood Cancer Patients and Survivors: A Systematic Review. [2021]

3. England 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. [2023]

4. United States 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. [2022]

5. United States 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. [2021]

6. Switzerland 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. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Validity of Three Survey Questions for Self-Assessed Sedentary Time. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Feasibility of a portable pedal exercise machine for reducing sedentary time in the workplace. [2022]

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

Accelerometry Shows Inpatients With Acute Medical or Surgical Conditions Spend Little Time Upright and Are Highly Sedentary: Systematic Review. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Motivational counseling to reduce sitting time: a community-based randomized controlled trial in adults. [2018]

11. England pubmed.ncbi.nlm.nih.gov

How to reduce sitting time? A review of behaviour change strategies used in sedentary behaviour reduction interventions among adults. [2023]

12. England pubmed.ncbi.nlm.nih.gov

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