Let's Play! Healthy Kids After Cancer

Study Overview
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Brief Summary
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This pilot study will evaluate the feasibility, acceptability, and potential efficacy of a parent-targeted, phone-based program to prevent unhealthy weight gain and improve biomarkers of oxidative stress and inflammation among childhood acute lymphoblastic leukemia survivors.

Detailed Description
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Acute lymphoblastic leukemia (ALL) is the most common childhood cancer, accounting for 25% of all childhood malignancies. Treatment of childhood ALL has a high success rate, with long-term event-free survival of >85%. Treatment success, however, has not come without cost. Recognition of long-term health problems related to childhood cancer therapies is growing. Both during and after therapy, children treated for ALL are at risk for fatigue, reduced physical activity, poor dietary intake, and excessive weight gain, which are driven by physiological (chemotherapy-induced) changes and social (home/environmental) factors. The goals of this pilot study are to evaluate the feasibility, acceptability, and potential efficacy of a parent-targeted, phone-delivered nutrition and physical activity program to prevent unhealthy weight gain among 60 childhood ALL survivors, 4-10 years of age. Participants will be randomly assigned to either the phone-delivered parent-targeted nutrition and physical activity intervention or a standard-of-care control group. Intervention success will be benchmarked by changes in key weight-related behaviors (physical activity and dietary intake) over the 6-month trial, and initial impact of the intervention on biomarkers of inflammation and oxidative stress, fatigue, and body composition will be examined.

Official Title
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Healthy Kids After Cancer: A Physical Activity and Nutrition Intervention

Conditions
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Childhood Acute Lymphoblastic Leukemia in Remission, Obesity

Intervention / Treatment
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* Behavioral: Phone Coaching Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 4.0 years and < 11.0 years of age at the time of recruitment Previously diagnosed of ALL and currently in remission Between 1-5 years post completion of chemotherapy BMI ≥ 85 percentile for age and sex (overweight or obese) OR at risk for obesity (BMI between the 50th and 85th percentile and at least one overweight parent (BMI ≥ 25 kg/m2) Exclusion Criteria: History of cranial radiation therapy History of bone marrow transplant History of relapse of ALL Diagnosis of Down's Syndrome Comorbidities of obesity that require immediate subspecialist referral Significant pulmonary, cardiovascular, orthopedic, or musculoskeletal problems that would, in their oncologist's judgment, limit their ability to participate in physical activity Significant psychiatric or neurologic disorders that would impair compliance with study protocol Current participation in a weight-loss program

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phone Coaching Program<br>Participants will receive a nutrition and physical activity phone coaching program, in addition to standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment. | Behavioral: Phone Coaching Program<br>* Participants in this group will receive a 10-session nutrition and physical activity program delivered via phone by a health behavior coach to promote healthy lifestyle changes. Participants will also receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.<br>|
| No Intervention: Standard Care Control<br>Participants will receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Number of participants who complete 8 of 10 intervention sessions | Measured by intervention session completion rates. | 6 months | 
| Retention: Number of participants who complete 6-month outcome assessments | Measured by completion of the 6-month outcome assessment. | 6 months | 
| Acceptability: Number of participants who report high satisfaction with the intervention | Measured by parent survey of satisfaction with intervention materials and sessions. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in children's physical activity | Measured by ActiGraph accelerometers | 6 months | 
| Change in children's dietary intake | Measured by Nutrition Data System for Research (NDSR) interview | 6 months | 
| Change in children's BMI | Staff-measured height and weight | 6 months | 
| Change in children's biomarker outcome measures | Measured by serum blood samples | 6 months | 
| Change in children's energy level | Measured by questionnaire: PedsQL Multidimensional Fatigue Scale | 6 months |