Rates of overweight and obesity for off-treatment pediatric cancer survivors (PCS) are high, ranging from about 40% in Acute Lymphoblastic Leukemia survivors to 50% among survivors of some sarcomas. However, in comparison to the general pediatric population where rates of overweight and obesity are also high (approx. 30%), the risk for concomitant negative health consequences is significantly greater in PCS. In line with recent calls in the literature and in accordance with the Institute of Medicine's (IOM) report on the importance of follow-up in promoting healthy behaviors in survivors, we propose a feasibility trial to deal with the increasing overweight and obesity rates among PCS by targeting their caregivers as key agents for PCS behavior change. We specifically focus on caregivers'behaviors, attitudes and roles in promoting healthier eating and physical activity (PA) in PCS and adapt an evidence-informed manualized parent intervention -- NOURISH -- found to be effective for caregivers of overweight and obese children and adolescents. We adapt NOURISH for caregivers of five - 11 year old PCS (6 months to 4 years off active cancer treatment). We propose a pilot feasibility RCT- NOURISH-T (Nourishing Our Understanding of Role modeling to Improve Support for Healthy Transitions) to evaluate 1) the preliminary effectiveness of NOURISH-T for pediatric cancer survivors, compared to an Enhanced Usual Care (EUC) control condition;and 2) factors to consider to improve future adaptations of the intervention, including determining the best time post-cancer treatment to offer the intervention to caregivers based on caregiver participation rates and response variability as a function of the PCS age, gender, race, and time since end of treatment. The proposed project will enroll caregivers of a total of 66 PCS at Virginia Commonwealth University (VCU) and the University of Pittsburgh and Children's Hospital of Pittsburgh (UP) to participate in the 6-session group intervention with assessments occurring pre and post the intervention and at a 6-month follow-up. Primary Specific Aims: 1. to document the feasibility of an optimal time post-cancer treatment to offer a health behavior change intervention (NOURISH-T) targeting eating and physical activity behaviors to caregivers of overweight and obese pediatric cancer survivors (PCS). 2. To test the preliminary efficacy of NOURISH-T on improving child dietary intake, PA, QOL and BMI. Secondary Aim: 3. To explore whether caregivers in NOURISH-T show improved dietary intake, PA, QOL, BMI, and lowered child vulnerability perceptions and child over-protectiveness than caregivers in EUC.
Approximately 40% of off-treatment pediatric cancer survivors (PCS) are overweight or obese;thereby increasing their risk for negative long-term physical health complications. In line with recent IOM calls urging a focus on patients transitioning from cancer to cancer survivorship and increasing long-term healthy behaviors in these survivors, the proposed study addresses the public health epidemic of obesity by conducting a pilot feasibility and preliminary efficacy randomized clinical trial. We adapt a previously tested intervention (NOURISH) to address overweight and obesity in PCS (NOURISH-for Healthy Transitions - NOURISH-T) by enhancing caregivers'ability to model healthy eating and physical activity behaviors to promote positive PCS health behavior change and long-term healthy weight.
|Stern, Marilyn; Ewing, Lin; Davila, Esther et al. (2015) Design and rationale for NOURISH-T: a randomized control trial targeting parents of overweight children off cancer treatment. Contemp Clin Trials 41:227-37|