Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors (NOURISH-T)

University of South Florida

Status: Completed

Conditions: Obesity; Cancer

Treatments: Behavioral: NOURISH-T; Behavioral: Enhanced Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02815982

5R21CA167259-02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 5 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

NOURISH-T

Experimental group

Description:

The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework is assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the "identified patient" or overweight child.

Treatment:

Behavioral: NOURISH-T

Enhanced Usual Care

Active Comparator group

Description:

Caregivers randomized to the EUC will attend assessment sessions and an initial session moderated by an independent interventionist. The session addresses the role of diet and exercise in pediatric overweight. In addition, EUC caregivers receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants also receive a booster phone call 2 months after the end of the intervention period.

Treatment:

Behavioral: Enhanced Usual Care