Let's Play! Healthy Kids After Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Phone Coaching Program 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
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.
|
| No Intervention: Standard Care Control Participants will receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment. |
Outcome Measures
Primary Outcome Measures
- Feasibility: Number of participants who complete 8 of 10 intervention sessions [6 months]
Measured by intervention session completion rates.
- Retention: Number of participants who complete 6-month outcome assessments [6 months]
Measured by completion of the 6-month outcome assessment.
- Acceptability: Number of participants who report high satisfaction with the intervention [6 months]
Measured by parent survey of satisfaction with intervention materials and sessions.
Secondary Outcome Measures
- Change in children's physical activity [6 months]
Measured by ActiGraph accelerometers
- Change in children's dietary intake [6 months]
Measured by Nutrition Data System for Research (NDSR) interview
- Change in children's BMI [6 months]
Staff-measured height and weight
- Change in children's biomarker outcome measures [6 months]
Measured by serum blood samples
- Change in children's energy level [6 months]
Measured by questionnaire: PedsQL Multidimensional Fatigue Scale
Eligibility Criteria
Criteria
Inclusion Criteria:
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Between 4.0 years and < 11.0 years of age at the time of recruitment
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Previously diagnosed of ALL and currently in remission
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Between 1-5 years post completion of chemotherapy
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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:
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History of cranial radiation therapy
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History of bone marrow transplant
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History of relapse of ALL
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Diagnosis of Down's Syndrome
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Comorbidities of obesity that require immediate subspecialist referral
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Significant pulmonary, cardiovascular, orthopedic, or musculoskeletal problems that would, in their oncologist's judgment, limit their ability to participate in physical activity
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Significant psychiatric or neurologic disorders that would impair compliance with study protocol
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Current participation in a weight-loss program
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota | United States | 55404 |
| 2 | Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 3 | St. Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
Sponsors and Collaborators
- HealthPartners Institute
- National Cancer Institute (NCI)
- Masonic Cancer Center, University of Minnesota
- Children's Hospitals and Clinics of Minnesota
- St. Jude Children's Research Hospital
Investigators
- Principal Investigator: Alicia S Kunin-Batson, PhD, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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. Review.
- 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.
- Rogers PC, Meacham LR, Oeffinger KC, Henry DW, Lange BJ. Obesity in pediatric oncology. Pediatr Blood Cancer. 2005 Dec;45(7):881-91. Review.
- 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.
- A13-175
- 1R21CA182727-01A1