Clinical trial NCT02815982: Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors
Official title: Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors (NOURISH-T)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cancer
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Johns Hopkins All Children's Hospital
First posted: 2016-06-28
Enrollment: 106
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This purpose of this pilot study is to investigate the feasibility of and optimal time post cancer treatment to offer caregivers a new health behavior change intervention (NOURISH-T), as well as assess its preliminary efficacy on specific child health behaviors. The study will also explore whether caregivers NOURISH-T exhibit more improvements than caregivers in EUC (standard care).

Detailed description: Approximately 40% of off-treatment pediatric cancer survivors (PCS) are overweight or obese, which increases their risk for negative long-term physical health complications. Consistent with the Institute of Medicine's (IOM) emphasis on patients transitioning from treatment to cancer survivorship and increasing long-term healthy behaviors in these survivors, we conducted a pilot RCT to address the increasing overweight/obesity rates among PCS by targeting their caregivers as agents for PCS behavior change. We focused on parents' behaviors, attitudes and roles in promoting healthier eating and physical activity (PA) in PCS and adapted an evidence-informed, manualized parent intervention - NOURISH - found to be effective for parents of overweight and obese children and adolescents in reducing child and adolescent BMI. We adapted NOURISH for caregivers of 5 - 13 year old PCS (6 months -4 years off active cancer treatment). Our pilot feasibility RCT - NOURISH-T (Nourishing Our Understanding of Role modeling to Improve Support for Healthy Transitions) evaluates: 1) the preliminary feasibility efficacy of NOURISH-T for PCS, compared with an Enhanced Usual Care (EUC) control condition, and 2) factors to consider to improve future adaptations of the intervention. The project enrolled caregivers of PCS at two pediatric oncology clinics into the 6-week intervention (or EUC) with assessments of both caregivers and PCS occurring pre- and post-6 weeks of intervention, and at a 4-month follow-up. In comparison to EUC, we hypothesized that caregivers and PCS assigned to the NOURISH-T condition would show greater improvements in dietary intake, physical activity, and in anthropometric health indicators over time.

Eligibility criteria: Inclusion Criteria:

Caregivers

* Mothers and fathers (biologic/adoptive/step parents/legal guardians) of pediatric cancer survivors
* 18 years or older
* Fluent in English

Pediatric Cancer Survivors

* Diagnosis of cancer
* between 5-13 years of age at study entry
* off active cancer treatment for 6 months to 4 years,
* reside with a participating caregiver
* able to engage in PA tailored to current medical status
* NOT taking medications that affect body weight, e.g., steroids within 6 months of enrollment
* at or above the 85th BMI %ile.

Exclusion Criteria:

Caregivers

* are non-ambulatory
* do not reside with the PCS at least 50% of the time.

Pediatric cancer survivor

* relapse during the intervention
* taken a medication known to affect body weight such as oral steroids or antipsychotic medications within 6 months of enrollment

Primary outcomes:
measure: Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE
timeFrame: 6 weeks
Secondary outcomes:
measure: Automated Self-administered 24-Hour Dietary Recall (ASA 24) -- CAREGIVERS ONLY MEASURE
timeFrame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
measure: Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS)
timeFrame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
measure: Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure
timeFrame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
measure: Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE
timeFrame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
measure: Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed
timeFrame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
measure: Child Waist to Hip Ratio -- ONLY Pediatric Cancer Survivors (PCS) ASSESSED
timeFrame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
measure: Parent BMI Score -- CAREGIVER MEASURE
timeFrame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
measure: Parent Waist to Hip Ratio -- CAREGIVER MEASURE
timeFrame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
measure: Number of Daily Steps Averaged Over a Week for Caregivers -- CAREGIVER MEASURE
timeFrame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of South Florida
name: Marilyn Stern, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stern M, Ewing L, Davila E, Thompson AL, Hale G, Mazzeo S. Design and rationale for NOURISH-T: a randomized control trial targeting parents of overweight children off cancer treatment. Contemp Clin Trials. 2015 Mar;41:227-37. doi: 10.1016/j.cct.2014.12.018. Epub 2015 Jan 2.
citation: Stern M, Bleck J, Ewing LJ, Davila E, Lynn C, Hale G, Mazzeo S. NOURISH-T: Targeting caregivers to improve health behaviors in pediatric cancer survivors with obesity. Pediatr Blood Cancer. 2018 May;65(5):e26941. doi: 10.1002/pbc.26941. Epub 2018 Jan 19.