Reduce Sedentary Time in Acute Lymphoblastic Leukemia (ReSeT in ALL)

Children's Hospital Los Angeles

Status

Completed

Conditions

Acute Lymphoblastic Leukemia (ALL)

Treatments

Behavioral: Sedentary time intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06182163

CHLA-23-00346

Details and patient eligibility

About

The goal of this feasibility 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.

Full description

Sedentary behaviors are highly prevalent among adolescents and young adults (AYAs) with acute lymphoblastic leukemia (ALL) and may worsen the cardiometabolic effects and deconditioning commonly associated with therapy. Additionally, sedentary lifestyles often persistent in to adulthood, increasing risk of chronic disease and early mortality in cancer survivors. Replacing sedentary time (ST) with short bouts of light activity has been shown to reduce adiposity and improve glucose metabolism. In adults, it has also been shown to decrease cancer incidence and cancer-specific mortality.

This pilot trial tests the feasibility and acceptability of a 10-week, multi-component mobile health ST intervention in adolescents and young adults (AYAs) with ALL and will inform future larger studies. Thirty participants will be enrolled and all will receive the intervention. They will receive a wearable fitness tracker with inactivity-triggered prompts to move and participate in an app-based peer support group as well as individualized coaching sessions.

Primary endpoints are intervention feasibility and acceptability. As a secondary endpoint, the trial will also evaluate if the intervention shows evidence that it may reduce device-measured and self-reported ST. Exploratory endpoints include the intervention's effect on participants' glucose and lipid metabolism, level of inflammation, and health-related quality of life and fatigue. Feasibility will be measured by recruitment rate, fitness tracker wear time, and retention rate; acceptability will be measured quantitatively via study exit surveys and qualitatively among intervention participants with exit interviews.

Enrollment

20 patients

Sex

All

Ages

12 to 21 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

12-21 years of age at time of enrollment
Diagnosis of lymphoblastic leukemia/lymphoma treated with Children's Oncology Group (COG)-based maintenance chemotherapy [B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/Ly), T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/Ly), mixed phenotype acute leukemia (MPAL)]
Has completed at least one month of maintenance chemotherapy and has at least one cycle (3 months) remaining.
Baseline sedentary lifestyle with a self-reported average of 4 or more leisure-time hours per day spent sedentary (verbal report)
Willing to reduce their sedentary time
Parent/legal guardian available for consent (if applicable), and patient available for assent or consent as applicable
Has access to internet and smartphone compatible with Fitbit and WhatsApp (own or parent/legal guardian's)
Ability to participate in virtual sessions with study staff
Fluent in English (Parent/legal guardian does not need to be fluent in English as long as they can provide consent, if needed, in their primary language)

Exclusion criteria

Evidence of recurrent or metastatic disease
Inability to obtain consent/assent
Medical contraindication to daily standing and light physical activity [>1.5 metabolic equivalents of task (METs)]
Intellectual disability or developmental delay which limits ability to fully participate in the study intervention
Unable to obtain laboratory studies
Unable to accurately perform quality of life surveys independently
Unable to complete study-related surveys
Pregnancy or current imprisonment