Improving Health Behaviors for Pediatric Cancer Survivors

Cynthia Gerhardt

Status: Terminated

Conditions: Cancer

Treatments: Behavioral: Surviving Strong for Kids (SS4K); Behavioral: Harvesting Hope for Kids (HH4K)

Study type: Interventional

Funder types: Other

Identifiers

NCT04097353

IRB1700469

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

31 participants in 2 patient groups

Harvesting Hope for Kids (HH4K)

Experimental group

Description:

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.

Treatment:

Behavioral: Harvesting Hope for Kids (HH4K)

Surviving Strong for Kids (SS4K)

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Surviving Strong for Kids (SS4K)