Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors

NCT02815982 | Completed Results

• 1 other identifier: 5R21CA167259-02
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

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).

Conditions

Obesity; Cancer

Outcome Measures

Primary Outcomes (1)

• Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE

  At the end of the final session (6-sessions), caregivers completed a likert-type survey assessing what they liked/disliked about the intervention, as well as what was/was not useful or helpful in reaching health goals. Eleven items were summed to obtain a total continuous composite satisfaction/liking score. Each item was measured on a likert scale ranging from strongly disagree (=1) to strongly agree (=5). The scale sum score ranged from 11 to 55 with higher scores indicating greater satisfaction with the intervention. More specifically, the higher the score, the more useful the caregiver thought the intervention and the more they liked participating in the intervention. Lower scores indicate that the caregiver thought the program was not useful and they did not like participating.

  6 weeks

Secondary Outcomes (9)

• Automated Self-administered 24-Hour Dietary Recall (ASA 24) -- CAREGIVERS ONLY MEASURE

  Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

• Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS)

  Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

• Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure

  Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

• Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE

  Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

• Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed

  Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

Study Arms (2)

NOURISH-T

EXPERIMENTAL

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.

Behavioral: NOURISH-T

Enhanced Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Usual Care

Interventions

NOURISH-T BEHAVIORAL

Overweight/obesity family intervention

NOURISH-T

Enhanced Usual Care BEHAVIORAL

Publicly available overweight/obesity materials

Enhanced Usual Care

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Caregivers
• Mothers and fathers (biologic/adoptive/step parents/legal guardians) of pediatric cancer survivors
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead
• University of Pittsburgh: collaborator
• Johns Hopkins All Children's Hospital: collaborator

Study Sites (2)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (2)

• 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.

  PMID: 25559916 BACKGROUND

• 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.

  PMID: 29350459 DERIVED

MeSH Terms

Conditions

Obesity; Neoplasms

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Self-report nature of the measures; Measurement error associated with the use of the pedometers; Differences in protocol between sites impacted sample size. Dyads were recruited, different measures were administered to caregivers and PCS.

Results Point of Contact

• Title: Dr. Marilyn Stern
• Organization: University of South Florida

mstern1@usf.edu

8139740966

Study Officials

• Marilyn Stern, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 28, 2016
• Study Start: December 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 20, 2018
• Results First Posted: September 20, 2018

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)