Improving Health Behaviors for Pediatric Cancer Survivors

NCT ID: NCT04097353

Last Updated: 2023-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-12-31

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.

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Harvesting Hope for Kids (HH4K)

Intervention Type: BEHAVIORAL

Weekly meetings at university-based farm

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.

Group Type: SHAM_COMPARATOR

Surviving Strong for Kids (SS4K)

Intervention Type: BEHAVIORAL

Enhanced usual care

Interventions

Harvesting Hope for Kids (HH4K)

Weekly meetings at university-based farm

Intervention Type: BEHAVIORAL

Surviving Strong for Kids (SS4K)

Enhanced usual care

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: collaborator

Cynthia Gerhardt

OTHER

Sponsor Role: lead

Responsible Party

Cynthia Gerhardt

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Cynthia Gerhardt, PhD

Role: PRINCIPAL_INVESTIGATOR

Abigail Wexner Research Institute at Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

IRB1700469

Identifier Type: -

Identifier Source: org_study_id