Improving Health Behaviors for Pediatric Cancer Survivors
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ClinicalTrials.gov Identifier: NCT04097353 |
Recruitment Status :
Suspended
(Study recruitment of new participants was suspended during 2020 due to the Covid-19 pandemic.)
First Posted : September 20, 2019
Last Update Posted : January 15, 2021
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Condition or disease | Intervention/treatment | Phase |
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Cancer | Behavioral: Harvesting Hope for Kids (HH4K) Behavioral: Surviving Strong for Kids (SS4K) | Not Applicable |
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 |

Arm | Intervention/treatment |
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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.
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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.
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Behavioral: Surviving Strong for Kids (SS4K)
Enhanced usual care |
- 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
- Change in Physical Activity [ Time Frame: Month 0 (baseline) to Month 2 (post-intervention) ]Daily step count, with higher counts indicating more physical activity
- 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
- 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
- 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
- Change in Blood Pressure [ Time Frame: Month 0 (baseline) to Month 2 (post-intervention) ]Lower scores indicate lower cardiometabolic risk
- 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
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097353
United States, Ohio | |
Nationwide Children's Hospital | |
Columbus, Ohio, United States, 43205 | |
The Ohio State University | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Cynthia Gerhardt, PhD | Abigail Wexner Research Institute at Nationwide Children's Hospital |
Responsible Party: | Cynthia Gerhardt, Associate Professor, Nationwide Children's Hospital |
ClinicalTrials.gov Identifier: | NCT04097353 |
Other Study ID Numbers: |
IRB1700469 |
First Posted: | September 20, 2019 Key Record Dates |
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 |
Behavioral Obesity Neoplasm |