NOURISH-ALL for Leukemia
(NOURISH-ALL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve support for families with children who have acute lymphoblastic leukemia (ALL). It engages families through six sessions incorporating cognitive behavioral therapy (a type of talk therapy) and family systems frameworks. The goal is to assess family participation and identify areas for intervention improvement. Families with children aged 2-12 who have completed the initial phase of ALL treatment but have not started maintenance therapy may be eligible. Participants should live together and be actively involved in the child's cancer care. As an unphased trial, this study offers families the chance to contribute to innovative support strategies that could enhance care for children with ALL.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor or the trial coordinators.
What prior data suggests that the NOURISH-ALL intervention is safe for families of youth with ALL?
Research shows that the NOURISH-ALL program aims to help families of children with acute lymphoblastic leukemia (ALL) maintain a healthy weight during treatment. While specific safety data for this program is not available, it emphasizes healthy lifestyle changes such as improved nutrition and family support. These programs are typically safe, as they do not involve medications or medical procedures.
Previous studies on similar lifestyle programs suggest minimal risks. They are generally safe because they use straightforward methods like improving diet and encouraging exercise, which are beneficial for most people. However, each family and individual is unique, so what works well for one may not work for another. Participants will provide feedback during the sessions, allowing the program to better fit family needs.
Prospective participants should consult a healthcare provider to determine if the program aligns with personal health goals and needs.12345Why are researchers excited about this trial?
Researchers are excited about the NOURISH-ALL trial because it's exploring a new approach to support families of young patients undergoing treatment for Acute Lymphoblastic Leukemia (ALL). Unlike traditional treatments that focus solely on the medical aspects of ALL, this intervention integrates cognitive behavioral therapy and family systems frameworks to address the emotional and psychological needs of both the patient and their family. By adapting the intervention based on real-time feedback from families and experts, the trial aims to create a highly personalized support system that could enhance family engagement and potentially improve overall treatment outcomes. This holistic and adaptive approach sets NOURISH-ALL apart from current standard care options, which typically do not incorporate such comprehensive family-centered support.
What evidence suggests that the NOURISH-ALL intervention is effective for participant engagement in families of youth with ALL?
Research has shown that good nutrition is crucial for treating acute lymphoblastic leukemia (ALL) in children. Poorly nourished children with ALL face a higher risk of infections, worsening their condition. Studies have found that early nutritional support can improve eating habits and may lead to better health outcomes for these young patients. Specifically, children who received targeted nutritional assistance had better diets after their treatment. Although more high-quality studies are needed, these findings suggest that focusing on nutrition could benefit children undergoing treatment for ALL. This trial will explore the NOURISH-ALL intervention, which aims to adapt and refine nutritional support for families of youth with ALL to optimize feasibility and acceptability.34678
Who Is on the Research Team?
Carolyn Bates, PhD
Principal Investigator
University of Kansas Medical Center
Keith August, MD
Principal Investigator
Children's Mercy Kansas City
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Intervention Adaptation
Adaptation of the NOURISH-T intervention to meet the specific needs of families during the early phases of ALL treatment.
Intervention Refinement
Refinement of the NOURISH-ALL intervention through sequential testing with individual families to optimize feasibility and acceptability.
Pilot Trial
Pilot single-arm trial of the finalized NOURISH-ALL intervention focused on participant engagement.
Follow-up
Participants are monitored for safety and effectiveness after treatment.
What Are the Treatments Tested in This Trial?
Interventions
- NOURISH-ALL
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Pilot testing key components of engagement is critical to optimizing design and methodology of fully powered efficacy trials. The purpose of Aim 2 is to pilot a single-arm trial of the finalized NOURISH-ALL intervention in a sample of families of youth in the early phases of ALL treatment to assess recruitment, retention, and dose received. Results will directly inform the design of the fully powered randomized control trial to test intervention efficacy (R01 application to be submitted in Year 4).
The purpose of Aim 1b is to adaptively refine NOURISH-ALL through sequential testing with individual families during the early phases of ALL treatment, with the goal of optimizing feasibility and acceptability from the family perspective. In line with the ORBIT model, the study will utilize an adaptive approach, similar to the commonly known "PDSA cycle," to maximize responsivity to individual patient/family feedback. Participants will receive NOURISH-ALL and provide feedback throughout the intervention (i.e., after each session and upon intervention completion), which will be iteratively analyzed and incorporated to improve intervention delivery for the next family
The purpose of Aim 1a is to adapt the NOURISH-T intervention to meet the specific needs of families during the early phases of ALL treatment. To achieve this goal, the study will initiate a three-step intervention adaptation process that includes (1) initial integration of cognitive behavioral therapy (CBT) and family systems frameworks, (2) formative assessment with families of youth with ALL, and (3) formative assessment with multidisciplinary experts.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator
Children's Mercy Hospital Kansas City
Collaborator
Citations
Effect of nutritional screening in children with acute ...
Moreover, malnourished ALL-children had 2 to 3 times prone to suffer from infection compared to well nourished (p = 0.024), and thus prolonged ...
Nutritional interventions in children with acute lymphoblastic ...
This review highlights the need to conduct high-quality randomized controlled trials for nutrition interventions in children with ALL.
The evolution of nutritional care in children and young people ...
Advances in treatment protocols have resulted in survival rates of >80% in most high‐income countries (HIC); however, children and young people (CYP) with ALL ...
4.
turkmedstudj.com
turkmedstudj.com/articles/effects-of-malnutrition-on-the-prognosis-of-pediatric-acute-lymphoblastic-leukemia-patients/tmsj.galenos.2022.09.01.03EFFECTS OF MALNUTRITION ON THE PROGNOSIS ...
Studies have been conducted to question the relationship between the prognosis and nutritional status of pediatric acute lymphoblastic leukemia ...
Impact of Early Nutritional Intervention During Cancer ...
The participants exposed to the VIE intervention showed specific improved dietary intakes at an average of 1.3 years post-treatment compared to a control group; ...
Healthy Weight Intervention Families During ALL ...
The purpose of this study is to conduct a single arm pilot of the NOURISH-ALL (Nourishing Our Understanding of Role modeling to Improve Support and Health in ...
Early Lifestyle Intervention for Obesity Prevention in ...
Patients with pediatric acute lymphoblastic leukemia (ALL) experience rapid weight gain during treatment and increases in weight are maintained throughout ...
Acute therapy-related toxicities in pediatric ...
The improved overall survival (OS) of children with acute lymphoblastic leukemia (ALL) exceeds today's 90% with the best contemporary treatment.1 However, a ...
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