Improving Health Behaviors for Pediatric Cancer Survivors

• ClinicalTrials.gov Identifier: NCT04097353
• Recruitment Status: Suspended
• First Posted: September 20, 2019
• Last Update Posted: January 15, 2021
• Sponsor: Cynthia Gerhardt
• Collaborator: Ohio State University
• Information provided by (Responsible Party): Cynthia Gerhardt, Nationwide Children's Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Cancer	Behavioral: Harvesting Hope for Kids (HH4K); Behavioral: Surviving Strong for Kids (SS4K)	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Families will be randomly assigned to the Harvesting Hope for Kids (HH4K) intervention or the enhanced usual care (Surviving Strong for Kids (SS4K) education group after the baseline assessment.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Harvesting Hope for Kids: Improving Diet and Physical Activity in Childhood Cancer Survivors
• Actual Study Start Date: May 1, 2017
• Estimated Primary Completion Date: October 31, 2021
• Estimated Study Completion Date: October 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Harvesting Hope for Kids (HH4K); Eight weekly, 60-minute sessions at a university-based farm with booster sessions. Learning is structured around fun activities to provide information about the impact of cancer treatment on children's health, as well as the importance of nutrition and physical activity in survivorship. Each session is manualized and devoted to education, a behavioral strategy applied toward a weekly goal, a cooking demonstration/taste testing, and harvesting produce from the survivor garden. Modules are offered in a group format with families together.	Behavioral: Harvesting Hope for Kids (HH4K); Weekly meetings at university-based farm
Sham Comparator: Surviving Strong for Kids (SS4K); Families assigned to enhanced usual care (SS4K) group will receive education in the form of standardized guidelines for nutrition and physical activity for survivors of childhood cancer. In a one-hour session, they will learn about the impact of cancer treatment on health and the importance of nutrition and physical activity for survivors. Families will receive websites for other educational resources. They will not have access to harvesting, remote coaching, the web portal, or behavioral training to address their child's nutrition or activity.	Behavioral: Surviving Strong for Kids (SS4K); Enhanced usual care

Outcome Measures

Primary Outcome Measures :

1. Change in Fruit and Vegetable Intake [ Time Frame: Month 0 (baseline) to Month 2 (post-intervention) ]
   Skin carotenoid score, with total scores ranging from 10,000-89,000+ and higher scores indicating more fruit and vegetable intake
2. Change in Physical Activity [ Time Frame: Month 0 (baseline) to Month 2 (post-intervention) ]
   Daily step count, with higher counts indicating more physical activity

Secondary Outcome Measures :

1. Change in Child Quality of Life [ Time Frame: Month 0 (baseline) to Month 2 (post-intervention) ]
   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
2. Change in Parent-rated Child Quality of Life [ Time Frame: Month 0 (baseline) to Month 2 (post-intervention) ]
   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
3. Change in Body Mass Index (BMI) [ Time Frame: Month 0 (baseline) to Month 2 (post-intervention) ]
   Height, weight, and age will be combined to report BMI in kg/m^2, with lower scores indicating lower cardiometabolic risk
4. Change in Blood Pressure [ Time Frame: Month 0 (baseline) to Month 2 (post-intervention) ]
   Lower scores indicate lower cardiometabolic risk
5. Change in Blood Lipids and Glucose [ Time Frame: Month 0 (baseline) to Month 2 (post-intervention) ]
   Blood lipids and glucose will provide TC/HDL ratio, non-HDL cholesterol, and LDL cholesterol, with lower scores indicating lower cardiometabolic risk
6. Change in Microbial Diversity [ Time Frame: Month 0 (baseline) to Month 2 (post-intervention) ]
   Stool samples will examine microbiome α- and β- diversity, with higher scores indicating greater microbial diversity

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Ohio

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

The Ohio State University

Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Cynthia Gerhardt

Ohio State University

Investigators

• Principal Investigator: Cynthia Gerhardt, PhD; Abigail Wexner Research Institute at Nationwide Children's Hospital

More Information

• Responsible Party: Cynthia Gerhardt, Associate Professor, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT04097353
• Other Study ID Numbers: IRB1700469
• First Posted: September 20, 2019
• Last Update Posted: January 15, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cynthia Gerhardt, Nationwide Children's Hospital:

Behavioral; Obesity; Neoplasm