Clinical trial NCT06182163: Reduce Sedentary Time in Acute Lymphoblastic Leukemia
Official title: ReSeT in ALL: A Single-arm Pilot Trial Testing a Multi-component Mobile Health Intervention to Reduce Sedentary Time in Adolescents and Young Adults (AYAs) With ALL During Maintenance Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Lymphoblastic Leukemia (ALL)
Keywords: Sedentary behavior(s)
sedentary time
physical inactivity
acute lymphoblastic leukemia (ALL)
adolescent(s)
mobile health (mHealth)
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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. Interim analysis will be completed once half of the enrollment goal has been reached (15) in order to inform future study, and final analysis will be completed once all 30 participants have completed.

Eligibility criteria: 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 cycle (3 months) of maintenance chemotherapy and has at least one cycle (3 months) remaining. Exception: Patients treated with nelarabine are eligible to enroll only after completion of nelarabine-containing cycles of maintenance therapy.
* 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

Primary outcomes:
measure: Number of participants enrolled at 6 months
timeFrame: 6 months
measure: Number of participants who have completed all baseline and exit questionnaires at 12 weeks
timeFrame: 12 weeks
measure: Average intervention participant fitness tracker wear time over 10 weeks
timeFrame: 10 weeks
measure: Participant satisfaction with the sedentary time intervention at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in average minutes per day of sedentary time from baseline to 12 weeks
timeFrame: 12 Weeks
measure: Change in average hours per day of uninterrupted sedentary time from baseline to 12 weeks
timeFrame: 12 Weeks
Other outcomes:
measure: Change in hemoglobinA1c level from baseline to 12 weeks
timeFrame: 12 weeks
measure: Change in fructosamine level from baseline to 8 weeks
timeFrame: 8 weeks
measure: Change in fructosamine level from baseline to 12 weeks
timeFrame: 12 weeks
measure: Change in C-reactive protein (CRP) level from baseline to 8 weeks
timeFrame: 8 weeks
measure: Change in C-reactive protein (CRP) level from baseline to 12 weeks
timeFrame: 12 weeks
measure: Change in self-reported health-related quality of life (HRQOL) from baseline to 12 Weeks
timeFrame: 12 weeks
measure: Change in self-reported fatigue from baseline to 12 Weeks
timeFrame: 12 weeks
measure: Change in total cholesterol from baseline to 12 weeks
timeFrame: 12 weeks
measure: Change in triglyceride level from baseline to 12 weeks
timeFrame: 12 weeks
measure: Change in LDL cholesterol level from baseline to 12 weeks
timeFrame: 12 weeks
measure: Change in HDL cholesterol level from baseline to 12 weeks
timeFrame: 12 weeks
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Brittany J Van Remortel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: