Improving Health Behaviors for Pediatric Cancer Survivors

Cancer Clinical Trial

Official title:

Harvesting Hope for Kids: Improving Diet and Physical Activity in Childhood Cancer Survivors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04097353
• Other study ID #: IRB1700469
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2023
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to examine the efficacy of Harvesting Hope for Kids (HH4K), a biobehavioral intervention delivered in the context of a university-based, cancer survivor garden, to increase produce intake and physical activity in survivors and caregivers.

Description:

Advances in treatment have led to a rapidly growing population of over 388,500 survivors, with 13,500 new survivors expected annually. However, chronic or long-term side effects (e.g., secondary malignancies, metabolic syndrome, cardio-pulmonary toxicities) can reduce quality of life and lead to premature death. The investigators propose that diet and fitness are two critical factors for healthy survivorship given their broad impact on late effects like obesity, fatigue, and metabolic syndrome. Despite the promise of comprehensive lifestyle interventions for children who are overweight or obese, research with survivors is limited by small samples and inconsistent effects. Novel research supports a key role for the gastrointestinal (GI) microbiome in regulating weight and health outcomes, yet no studies have examined the "obesogenic" microbiome in the context of lifestyle interventions for survivors of childhood cancer. The objective of this RCT is to examine the efficacy of Harvesting Hope for Kids (HH4K), a biobehavioral intervention delivered in the context of a university-based, cancer survivor garden, to increase produce intake and physical activity in survivors and caregivers. Families will be randomized to participate in HH4K or enhanced usual care. Dietary patterns, physical activity, cardiometabolic indices, family outcomes, and GI microbiome will be assessed and the HH4K group will demonstrate greater improved than enhanced usual care.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• 8-12 years of age

• previously diagnosed with any type of pediatric cancer

• within 5 years post-treatment for pediatric cancer

• fluent in English, with at least 1 fluent parent

• living within 75 miles of the medical center

Exclusion Criteria:

• significant developmental disorder or cognitive difficulties that would interfere with children and caregivers completing questionnaires

• Referral to hospice or at end of life.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Harvesting Hope for Kids (HH4K)
Weekly meetings at university-based farm
• Surviving Strong for Kids (SS4K)
Enhanced usual care

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Cynthia Gerhardt	Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fruit and Vegetable Intake	Skin carotenoid score, with total scores ranging from 10,000-89,000+ and higher scores indicating more fruit and vegetable intake	Month 0 (baseline) to Month 2 (post-intervention)
Primary	Change in Physical Activity	Daily step count, with higher counts indicating more physical activity	Month 0 (baseline) to Month 2 (post-intervention)
Secondary	Change in Child Quality of Life	Children will complete the Pediatric Quality of Life Inventory (PedsQL), with total scores ranging from 0-92 and subscale scores ranging from 0-20/32; Higher scores indicate better quality of life	Month 0 (baseline) to Month 2 (post-intervention)
Secondary	Change in Parent-rated Child Quality of Life	Parents will complete the Pediatric Quality of Life Inventory (PedsQL) for parents, with total scores ranging from 0-92 and subscale scores ranging from 0-20/32; Higher scores indicate better quality of life	Month 0 (baseline) to Month 2 (post-intervention)
Secondary	Change in Body Mass Index (BMI)	Height, weight, and age will be combined to report BMI in kg/m^2, with lower scores indicating lower cardiometabolic risk	Month 0 (baseline) to Month 2 (post-intervention)
Secondary	Change in Blood Pressure	Lower scores indicate lower cardiometabolic risk	Month 0 (baseline) to Month 2 (post-intervention)
Secondary	Change in Blood Lipids and Glucose	Blood lipids and glucose will provide TC/HDL ratio, non-HDL cholesterol, and LDL cholesterol, with lower scores indicating lower cardiometabolic risk	Month 0 (baseline) to Month 2 (post-intervention)
Secondary	Change in Microbial Diversity	Stool samples will examine microbiome a- and ß- diversity, with higher scores indicating greater microbial diversity	Month 0 (baseline) to Month 2 (post-intervention)