NOURISH-T+ Weight Management for Childhood Cancer Survivors

(NOURISH-T+ Trial)

Recruiting at 6 trial locations

Overseen By Flandra Ismajli, BSW

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Must not be taking: Steroids

Disqualifiers: Non-ambulatory, Pregnant, Wards of state

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

520 Participants Needed

Trial Summary

What is the purpose of this trial?

Pediatric cancer survivors are at an increased risk of excessive weight gain and reduced exercise behaviors with the potential for this risk to worsen over time. With over 80% of pediatric cancer patients living to adulthood, many pediatric cancer survivors experience long-term health consequences such as heart disease - the leading cause of death in this population. The purpose of this clinical research study is to teach parents/caregivers skills that will help prevent and reduce the problems of obesity in childhood cancer survivors. In this study, parents have the opportunity to participate in one of two web-based groups in which parents in either group will learn valuable information to improve the health of their child and of themselves.

Will I have to stop taking my current medications?

Participants must not be taking medications that affect body weight, like steroids, within 6 months of joining the study.

What data supports the effectiveness of the treatment NOURISH-T+ for weight management in childhood cancer survivors?

The NOURISH-T+ treatment builds on the success of a previous pilot trial, NOURISH-T, which showed promise in helping parents of overweight children improve their children's weight and health behaviors. The new trial aims to further test its effectiveness by involving parents in a structured program to promote healthier eating and physical activity in childhood cancer survivors. ^{1 2 3 4 5}

Is NOURISH-T+ safe for childhood cancer survivors?

The NOURISH-T+ program has been tested in a pilot trial and is being further evaluated in a larger study, but specific safety data for NOURISH-T+ itself is not detailed in the available research. However, the program involves nutritional counseling and lifestyle changes, which are generally considered safe for children. ^{1 6 7 8 9}

How does the NOURISH-T+ treatment differ from other treatments for weight management in childhood cancer survivors?

NOURISH-T+ is unique because it focuses on involving parents in a structured, remote intervention to improve the dietary and physical activity behaviors of childhood cancer survivors, unlike standard care which typically offers only informational sessions. This approach includes multiple sessions with a dietician and booster sessions, aiming to create long-term healthy habits in both children and their parents. ^{1 3 4 7 10}

Research Team

Marilyn Stern, PhD

Principal Investigator

University of South Florida

Eligibility Criteria

This trial is for English or Spanish-speaking pediatric cancer survivors aged 5-14, who are overweight (above the 85th BMI percentile), off treatment for at least 6 months, and in remission. Their parents must be adults, main meal preparers, and able to exercise according to their medical status. Pregnant women and non-ambulatory individuals cannot participate.

Inclusion Criteria

I haven't received any cancer treatment for the last 6 months.

I can complete assessments with help from clinic staff and the research team.

My cancer is currently in remission.

Exclusion Criteria

In addition, children who are wards of the state will be excluded from the study

I can walk and live with my child at least half the time.

I am not currently pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

NOURISH-T+ group receives 6 weekly, 1-1.5 hour sessions via video-conferencing, with additional sessions for child engagement and a session with a pediatric oncology dietician.

6 weeks

6 weekly sessions (virtual), 2 additional sessions (virtual), 1 session with dietician (virtual)

Follow-up

Brief booster sessions at 2-, 4-, 8-, and 10-months post-intervention to maximize retention and follow-up participation.

10 months

4 booster sessions (virtual)

Outcome Measures

Outcome measures completed at baseline, 3-, 6-, and 12-months post-intervention to assess changes in child eating behaviors, parent BMI, and child physical activity behaviors.

12 months

Treatment Details

Interventions

• Brief NOURISH-T+
• NOURISH-T+

Trial Overview The NOURISH-T+ study aims to teach parents of childhood cancer survivors how to prevent obesity through two web-based educational groups. It focuses on healthy eating and exercise behaviors with the goal of improving long-term health outcomes like reducing heart disease risk.

Participant Groups

Group I: NOURISH-T+ Experimental Treatment 1 Intervention

NOURISH-T+ targets parents as agents of change by providing intensive parent skills training emphasizing role modeling of positive health behaviors to foster the development of healthy eating and physical activity in pediatric cancer survivors. The NOURISH-T+ group will have 6 weekly, 1-1.5 hour, manualized sessions delivered using video-conferencing. There will be 2 additional brief sessions where the child will participate along with their parent to promote child engagement. Additionally, there will be one session with a pediatric oncology dietician based out of Nicklaus Children's Hospital who will discuss personalized nutritional strategies. Brief booster sessions at 2-, 4-, 8-, and 10- months will maximize retention and follow-up participation. NOURISH-T+ content is theory-based, manualized, and builds upon strengths of our prior work with NOURISH-T (our pilot) and NOURISH (our work with otherwise healthy overweight and obese children).

Group II: EUC - Brief NOURISH-T+ Active Control 1 Intervention

The EUC condition (Brief NOURISH-T+) engages parents in one information session moderated by a USF-based interventionist using videoconferencing. Session content is taken from the publicly available We Can! Manual. Parents in this group will receive nationally available web-based brochures on pediatric overweight/obesity on two occasions during the 6 weeks that NOURISH-T+ families participate in the study. Check-ins will take place at 2-, 4-, 8-, and 10- months post-intervention.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The NOURISH-T+ intervention aims to address the high rates of overweight and obesity among pediatric cancer survivors by providing a comprehensive 6-session program for parents, which includes dietary guidance and physical activity support, targeting children aged 5-12 who are at least 6 months off treatment.

This larger randomized control trial will involve 260 parent-child pairs from four pediatric oncology clinics, assessing the intervention's effectiveness on children's BMI, physical activity, and dietary behaviors over 12 months, compared to a standard care approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cluster-randomized control trial targeting parents of pediatric cancer survivors with obesity: Rationale and study protocol of NOURISH-T. Stern, M., Gray, HL., Ruble, K., et al.[2022]

Nutritional status at the time of cancer diagnosis significantly affects survival outcomes in children, with both under-nourished and over-nourished children experiencing worse overall survival and event-free survival rates.

Specifically, children with leukemia who had a higher body mass index at diagnosis faced a 30-50% increased risk of death and relapse, while malnourished children with osteosarcoma and Ewing sarcoma had higher treatment-related toxicity, highlighting the importance of nutritional management in pediatric cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Status at Diagnosis as Predictor of Survival from Childhood Cancer: A Review of the Literature. Karalexi, MA., Markozannes, G., Tagkas, CF., et al.[2022]

This scoping review analyzed 9 studies on malnutrition in pediatric cancer treatment, revealing that various nutritional interventions, such as appetite stimulants and supplements, can lead to improved weight outcomes, although the specific methods used showed no significant differences in effectiveness.

The review highlighted a lack of standardized definitions and screening tools for malnutrition, indicating that while some screening methods may reduce malnutrition risk and improve weight gain, there is a critical need for consistent assessment and treatment strategies in pediatric oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Malnutrition screening and treatment in pediatric oncology: a scoping review. Franke, J., Bishop, C., Runco, DV.[2022]

A pilot randomized controlled trial (RCT) called NOURISH-T aims to reduce overweight and obesity rates among pediatric cancer survivors (PCS) by targeting their caregivers to promote healthier eating and physical activity, focusing on children aged 5-12 who are 6 months to 4 years off active treatment.

The intervention adapts an existing program, NOURISH, which has previously been effective in reducing BMI in overweight children, and will assess its preliminary efficacy compared to Enhanced Usual Care over a 6-week period, with follow-up assessments at 4 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and rationale for NOURISH-T: a randomized control trial targeting parents of overweight children off cancer treatment. Stern, M., Ewing, L., Davila, E., et al.[2021]

Children undergoing cancer treatment have significantly higher fat mass and lower body cell mass compared to healthy controls, indicating a risk of overnutrition during treatment.

Both children currently in treatment and childhood cancer survivors show high rates of undernutrition, with 48% and 53% respectively, highlighting the need for nutritional support in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body composition of children with cancer during treatment and in survivorship. Murphy, AJ., White, M., Elliott, SA., et al.[2023]

Among 62 survivors of childhood acute lymphoblastic leukemia (ALL), obesity and overweight rates varied significantly by age group, with 73% of preschool children, 68% of school-age children, and 47% of adolescents being classified as obese or overweight at some point after diagnosis.

Preschool children showed the fastest increase in obesity rates immediately following therapy, highlighting the need for targeted obesity prevention efforts in this age group before treatment completion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trajectories of Obesity and Overweight Rates Among Survivors of Childhood Acute Lymphoblastic Leukemia. Winkler, MR., Hockenberry, MJ., McCarthy, KS., et al.[2017]

In a study of 221 pediatric patients with solid tumors treated with cisplatin, obesity at diagnosis was linked to a more than threefold increased risk of severe treatment-related toxicities (TRT), particularly kidney injuries.

Obesity and being an adolescent or young adult at diagnosis were associated with significantly worse event-free and overall survival rates, indicating that these groups may require closer monitoring and tailored interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of body mass index with toxicity and survival in pediatric patients treated with cisplatin-containing regimens. Bhandari, R., Scott, E., Yeh, MY., et al.[2022]

Childhood cancer survivors (CCS) treated with cranial/craniospinal radiotherapy (CRT) showed a higher prevalence of overweight at final height (14%) compared to age-matched controls (4%), indicating a significant impact of CRT on long-term weight outcomes.

In contrast, CCS who received high doses of anthracyclines (> 300 mg/m²) were more likely to be underweight at final height, and they experienced a lower annual increase in BMI, suggesting that different cancer treatments have distinct effects on body weight and growth patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body mass index and annual increase of body mass index in long-term childhood cancer survivors; relationship to treatment. Brouwer, CA., Gietema, JA., Vonk, JM., et al.[2021]

Nutritional status during cancer treatment significantly affects treatment-related toxicities and outcomes in children and adolescents, with lasting impacts into survivorship.

Many childhood cancer survivors do not meet recommended dietary guidelines, which may lead to negative nutrition-related health outcomes, highlighting the need for further research to inform clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Counseling in Survivors of Childhood Cancer: An Essential Component of Survivorship Care. Ladas, EJ.[2020]

Among 50 childhood cancer survivors assessed, 20% were overweight or obese, and 54% consumed more calories than recommended, indicating a need for dietary interventions.

Parents of these survivors tended to use restrictive feeding practices, which may contribute to poor dietary habits, suggesting that addressing both dietary intake and parenting styles could help mitigate long-term health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary intake after treatment in child cancer survivors. Cohen, J., Wakefield, CE., Fleming, CA., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

A cluster-randomized control trial targeting parents of pediatric cancer survivors with obesity: Rationale and study protocol of NOURISH-T. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Nutritional Status at Diagnosis as Predictor of Survival from Childhood Cancer: A Review of the Literature. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Malnutrition screening and treatment in pediatric oncology: a scoping review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Design and rationale for NOURISH-T: a randomized control trial targeting parents of overweight children off cancer treatment. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Body composition of children with cancer during treatment and in survivorship. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Trajectories of Obesity and Overweight Rates Among Survivors of Childhood Acute Lymphoblastic Leukemia. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Association of body mass index with toxicity and survival in pediatric patients treated with cisplatin-containing regimens. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Body mass index and annual increase of body mass index in long-term childhood cancer survivors; relationship to treatment. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Nutritional Counseling in Survivors of Childhood Cancer: An Essential Component of Survivorship Care. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Dietary intake after treatment in child cancer survivors. [2015]