Clinical trial NCT02361047: Let's Play! Healthy Kids After Cancer
Official title: Healthy Kids After Cancer: A Physical Activity and Nutrition Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Acute Lymphoblastic Leukemia in Remission
Obesity
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Masonic Cancer Center, University of Minnesota
name: Children's Hospitals and Clinics of Minnesota
name: St. Jude Children's Research Hospital
First posted: 2015-02-11
Enrollment: 42
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: Number of participants who complete 8 of 10 intervention sessions
timeFrame: 6 months
measure: Retention: Number of participants who complete 6-month outcome assessments
timeFrame: 6 months
measure: Acceptability: Number of participants who report high satisfaction with the intervention
timeFrame: 6 months
Secondary outcomes:
measure: Change in children's physical activity
timeFrame: 6 months
measure: Change in children's dietary intake
timeFrame: 6 months
measure: Change in children's BMI
timeFrame: 6 months
measure: Change in children's biomarker outcome measures
timeFrame: 6 months
measure: Change in children's energy level
timeFrame: 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: University of Minnesota
name: Alicia S Kunin-Batson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rogers PC, Meacham LR, Oeffinger KC, Henry DW, Lange BJ. Obesity in pediatric oncology. Pediatr Blood Cancer. 2005 Dec;45(7):881-91. doi: 10.1002/pbc.20451.
citation: Ness KK, Armenian SH, Kadan-Lottick N, Gurney JG. Adverse effects of treatment in childhood acute lymphoblastic leukemia: general overview and implications for long-term cardiac health. Expert Rev Hematol. 2011 Apr;4(2):185-97. doi: 10.1586/ehm.11.8.
citation: Ness KK, Leisenring WM, Huang S, Hudson MM, Gurney JG, Whelan K, Hobbie WL, Armstrong GT, Robison LL, Oeffinger KC. Predictors of inactive lifestyle among adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Cancer. 2009 May 1;115(9):1984-94. doi: 10.1002/cncr.24209.
citation: Cohen J, Wakefield CE, Fleming CA, Gawthorne R, Tapsell LC, Cohn RJ. Dietary intake after treatment in child cancer survivors. Pediatr Blood Cancer. 2012 May;58(5):752-7. doi: 10.1002/pbc.23280. Epub 2011 Aug 17.
citation: Mayer EI, Reuter M, Dopfer RE, Ranke MB. Energy expenditure, energy intake and prevalence of obesity after therapy for acute lymphoblastic leukemia during childhood. Horm Res. 2000;53(4):193-9. doi: 10.1159/000023566.
citation: Sherwood NE, Levy RL, Langer SL, Senso MM, Crain AL, Hayes MG, Anderson JD, Seburg EM, Jeffery RW. Healthy Homes/Healthy Kids: a randomized trial of a pediatric primary care-based obesity prevention intervention for at-risk 5-10 year olds. Contemp Clin Trials. 2013 Sep;36(1):228-43. doi: 10.1016/j.cct.2013.06.017. Epub 2013 Jun 28.