CancerNCT04097353
Improving Health Behaviors for Pediatric Cancer Survivors
A study testing Harvesting Hope for Kids (HH4K) and Surviving Strong for Kids (SS4K) in people with Cancer, run by Cynthia Gerhardt at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Harvesting Hope for Kids (HH4K) and Surviving Strong for Kids (SS4K)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- significant developmental disorder or cognitive difficulties that would interfere with children and caregivers completing questionnaires
- Referral to hospice or at end of life.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nationwide Children's Hospital
Columbus, Ohio, 43205
The Ohio State University
Columbus, Ohio, 43210
About this study
Official title: Harvesting Hope for Kids: Improving Diet and Physical Activity in Childhood Cancer Survivors
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.
Read the 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
- Being tested
- Harvesting Hope for Kids (HH4K), Surviving Strong for Kids (SS4K)
- Keywords
- Behavioral, Obesity, Neoplasm
- Medical subject headings
- Neoplasms, Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harvesting Hope for Kids (HH4K)Behavioural
Weekly meetings at university-based farm
Surviving Strong for Kids (SS4K)Behavioural
Enhanced usual care
| Study group | Role | What they receive |
|---|---|---|
| Harvesting Hope for Kids (HH4K) | Experimental | 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. Receives: Behavioral: Harvesting Hope for Kids (HH4K) |
| Surviving Strong for Kids (SS4K) | Sham comparator | 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. Receives: Behavioral: Surviving Strong for Kids (SS4K) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 0 (baseline) to Month 2 (post-intervention)
Change in Physical Activity
Daily step count, with higher counts indicating more physical activity
Measured: Month 0 (baseline) to Month 2 (post-intervention)
Secondary outcomes (6)
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
Measured: Month 0 (baseline) to Month 2 (post-intervention)
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
Measured: Month 0 (baseline) to Month 2 (post-intervention)
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
Measured: Month 0 (baseline) to Month 2 (post-intervention)
Change in Blood Pressure
Lower scores indicate lower cardiometabolic risk
Measured: Month 0 (baseline) to Month 2 (post-intervention)
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
Measured: Month 0 (baseline) to Month 2 (post-intervention)
Change in Microbial Diversity
Stool samples will examine microbiome α- and β- diversity, with higher scores indicating greater microbial diversity
Measured: Month 0 (baseline) to Month 2 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 May 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Study recruitment of new participants was suspended during 2020 due to the Covid-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynthia Gerhardt
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Sponsor-investigator, Cynthia Gerhardt, Nationwide Children's Hospital
- Investigators
- Cynthia Gerhardt, PhD, Principal investigator, Abigail Wexner Research Institute at Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097353
- Sponsor's protocol ID
- IRB1700469
- Status last verified
- Mar 2023
- First submitted
- 10 Sep 2019
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harvesting Hope for Kids: Improving Diet and Physical Activity in Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT04097353
- Acronym / sponsor ID
- IRB1700469
- Conditions
- Cancer
- Keywords
- Behavioral, Obesity, Neoplasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study recruitment of new participants was suspended during 2020 due to the Covid-19 pandemic.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Cynthia GerhardtUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Harvesting Hope for Kids (HH4K) | Experimental | Behavioral: 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. |
| Surviving Strong for Kids (SS4K) | Sham comparator | Behavioral: 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- significant developmental disorder or cognitive difficulties that would interfere with children and caregivers completing questionnaires
- Referral to hospice or at end of life.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Harvesting Hope for Kids (HH4K)Weekly meetings at university-based farm | Behavioural | Harvesting Hope for Kids (HH4K) |
| Surviving Strong for Kids (SS4K)Enhanced usual care | Behavioural | Surviving Strong for Kids (SS4K) |
Primary outcome
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
6 secondary outcomes
Change in Child Quality of Life
Time frame: Month 0 (baseline) to Month 2 (post-intervention)
Change in Parent-rated Child Quality of Life
Time frame: Month 0 (baseline) to Month 2 (post-intervention)
Change in Body Mass Index (BMI)
Time frame: Month 0 (baseline) to Month 2 (post-intervention)
Change in Blood Pressure
Time frame: Month 0 (baseline) to Month 2 (post-intervention)
Change in Blood Lipids and Glucose
Time frame: Month 0 (baseline) to Month 2 (post-intervention)
Change in Microbial Diversity
Time frame: Month 0 (baseline) to Month 2 (post-intervention)
Results and safety
The study was stopped early (reason given: Study recruitment of new participants was suspended during 2020 due to the Covid-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Gerhardt, PhD principal investigator
Abigail Wexner Research Institute at Nationwide Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Harvesting Hope for Kids (HH4K) and Surviving Strong for Kids (SS4K) in people with Cancer, run by Cynthia Gerhardt at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study recruitment of new participants was suspended during 2020 due to the Covid-19 pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fruit and Vegetable Intake (time frame: Month 0 (baseline) to Month 2 (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.