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Acute lymphoblastic leukemia (ALL) is the most common cancer in children and, along with lymphoblastic lymphoma, represents the most common group of childhood lymphoid malignancies. Survival rates have improved over the years, but many children still experience long-term side effects from treatment. These can include tiredness, weak muscles, pain, nerve problems, difficulty moving, and other physical challenges. Many children with ALL are also overweight at diagnosis, and weight gain often continues during treatment. As a result, about half of childhood leukemia survivors have a BMI at or above the 85th percentile.
Treatment decisions are usually based on a child's symptoms and genetic risk factors. However, some risk factors such as physical activity can be modified. Exercise during treatment may help children feel better and may even improve survival. However, research on early symptom tracking and structured exercise during the first phase of chemotherapy is limited, uses different methods, and often does not include reliable patient-reported symptoms.
Effective exercise programs for children with ALL and lymphoblastic lymphoma need to consider the child's age, treatment side effects, motivation, family support, and ways to encourage long-term behavior change. Because children spend little time in the hospital during the induction phase, a mix of in-person and virtual sessions supported by real-time Zoom instruction can make it possible to offer safe and supervised exercise at home.
This study will use a guided exercise plan that includes tools to track sets, repetitions, intensity, warm-up time, and perceived exertion. These tools help with consistent monitoring and support both patients and caregivers throughout the program. Twenty children newly diagnosed with ALL or lymphoblastic lymphoma who receive standard 3-4 drug induction chemotherapy will be invited to participate. Our goal is to determine whether a 9-week hybrid exercise program, combined with weekly symptom check-ins, is practical and achievable in both hospital and home settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with Acute lymphoblastic lymphoma or Acute lymphoblastic leukemia (ALL) | Experimental | Children diagnosed with Acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma who are medically able to exercise will be eligible to join the exercise program. |
|
| Caregivers of Children with Acute lymphoblastic lymphoma or Acute lymphoblastic leukemia (ALL) | No Intervention | Caregivers of Children diagnosed with Acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma who are medically able to exercise will be eligible to join the exercise program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercises | Behavioral | Participants will follow a strength-training routine using rubber resistance bands and their own body weight, completing exercises at least three times per week and recording the time spent on their study form. They will receive ongoing support through optional Zoom or phone check-ins, with the choice to join group online sessions or complete supervised sessions individually. The intervention begins Day 8 and continues through Consolidation Day 29. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects completed exercise intervention | The proportion of subjects who attend at least 16 of 24 total (3 per week) exercise sessions and complete ≥ 60% of the prescribed exercise plan. | Up to 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to capture weekly functional activity | The proportion of subjects who have ≥ 75% of functional profile variables successfully collected in at least 75% (18 of 24) of sessions. | Up to 9 weeks |
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Inclusion Criteria for children:
All subjects must meet the following criteria:
Exclusion Criteria for children:
Optional caregiver participation:
Inclusion Criteria :All caregivers must meet the following criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Buddenbaum, MS | Contact | 919-966-4432 | jessica_buddenbaum@med.unc.edu | |
| Juanita Cuffee | Contact | 919-216-0463 | cuffee@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Alexander, MD, MPH | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials | View source |
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|
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015430 | Weight Gain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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