Clinical Trials Logo

Clinical Trial Summary

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 Acute Lymphoblastic Leukemia) intervention focused on three components of participant engagement. This is a single arm intervention study that involves participation in a 6-session family intervention and three time points of multimethod data collection. The primary outcome is participant engagement, measured as recruitment, retention, and intended dose received. This study will be conducted over 5 years in three phases: - Aim 1a: Adapting the NOURISH-ALL Intervention for Families of Youth with ALL (Year 1) - Aim 1b: Iteratively Refining the NOURISH-ALL Intervention (Year 2) - Aim 2: Pilot Single-Arm Trial of NOURISH-ALL Focused on Participant Engagement (Years 3-5)


Clinical Trial Description

The long-term goal of this work is to establish an efficacious family-based health promotion intervention that curbs excessive weight gain among youth with newly diagnosed acute lymphoblastic leukemia (ALL) by integrating support for family coping with stress during the early phases of treatment. The objectives of the current study are to adapt an existing family-based health promotion intervention, NOURISH-T, to meet the needs of families of youth in the early phases of ALL treatment (NOURISH-ALL) and (2) assess three key components of engagement in preparation for a fully powered efficacy trial. NOURISH-T is a 6-session family-based health promotion intervention that has demonstrated improved physical activity (PA), dietary intake, and weight among youth who are cancer survivors. Guided by the ORBIT Model of Behavioral Intervention Development, this study will modify NOURISH-T to fit the early ALL treatment context through a multi-stage adaptation and refinement process. Adaptations will incorporate family systems and cognitive behavioral intervention components to support healthy family coping with diagnosis and treatment stress. Additional, patient-centered adaptations will be informed by semi-structured family input around intervention content and delivery. The central hypothesis is that this rigorous approach to adaptation will yield an intervention that is feasible, acceptable, and engaging for families of youth with ALL. By incorporating tailored strategies for health promotion during the early phases of ALL treatment, the proposed study seeks to shift clinical practice paradigms to prevent weight-related disparities in treatment outcomes. Hypothesis: The central hypothesis is that this rigorous approach to adaptation will yield an intervention that is feasible, acceptable, and engaging for families of youth with ALL. Aims: AIM 1: To (a) adapt the NOURISH-T intervention to target the early phases of ALL treatment (NOURISH-ALL) and (b) refine this ALL-tailored intervention for optimal feasibility and acceptability from the patient and family perspective. (Years 1-2) Defining the specific needs of families of youth with newly diagnosed ALL is essential to effectively adapting behavior change interventions to the early phases of ALL treatment. Refining interventions for optimal feasibility and acceptability from the family perspective is critical to successful intervention development. Aim 1a: Intervention Adaptation. 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. Aim 1b. Refinement to Optimize Feasibility and Acceptability. 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. AIM 2: To conduct an external pilot single-arm trial of NOURISH-ALL focused on three components of engagement. (Years 3-5). 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06050850
Study type Observational
Source University of Kansas Medical Center
Contact Carolyn Bates, PhD
Phone 913-588-6323
Email cbates4@kumc.edu
Status Recruiting
Phase
Start date October 17, 2023
Completion date October 1, 2029

See also
  Status Clinical Trial Phase
Completed NCT03305731 - Activating Behavior for Lasting Engagement After Stroke N/A
Completed NCT04035395 - Salud y Vida 2.0: Enhancing Integrated Behavioral Health for Diabetics in the Rio Grande Valley N/A
Active, not recruiting NCT06089876 - The Use of Mobile Applications in Obese and Overweight Adolescents for Health Improvement N/A
Active, not recruiting NCT06057727 - Behavioral Economics to Improve Flu Vaccination Using EHR Nudges N/A
Not yet recruiting NCT04096404 - Gene-based Personalised Diet and Physical Activity Advice on Adiposity Indices Personalised Diet and Physical Activity Advice on Adiposity Indices in University Students N/A
Completed NCT05100524 - Motivational Interview for Daily Living Activities in Elderly People Undergoing Total Knee Replacement N/A
Recruiting NCT06394882 - FamCe-HLP- Family-centered Obesity Management Program in Primary Care Settings N/A
Not yet recruiting NCT04961983 - A Comprehensive Travel Health Education for Tour Guides in Bali, Indonesia N/A
Enrolling by invitation NCT06408844 - Examining the Impact of Behavior Change Intervention N/A
Completed NCT04809519 - Integrative Nursing Based Multimodal Interventions for Uncontrolled Hypertensives N/A
Suspended NCT04113213 - Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health N/A
Completed NCT04042467 - Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention N/A
Active, not recruiting NCT04641689 - Stand Up Kansas: An Intervention to Reduce Sedentary Behavior in the Home Work Environment N/A
Withdrawn NCT04467034 - Evaluation of The Stanford Tobacco Prevention Toolkit N/A
Completed NCT03315286 - Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure N/A
Completed NCT04522245 - Evaluation of Brain Activity Changes After a Behavior Change Weight Loss Intervention N/A
Active, not recruiting NCT04633070 - Systematic Review of Health App Gamification for Lifestyle Intervention Adherence
Completed NCT03961061 - Increased Monitoring of Physical Activity and Calories With Technology N/A
Active, not recruiting NCT03734055 - Peer Approaches to Lupus Self-management N/A
Completed NCT03309787 - Health Coaching & Technology in a Weight Loss Center