RightFit
Not yet recruitingNot applicable

Healthy Weight Intervention Families During ALL Treatment: NOURISH-ALL

A Healthy Weight Intervention for Family Stress During the Early Phases of ALL Treatment: NOURISH-ALL

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years to 12 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests NOURISH-ALL, a six-session family program focused on healthy weight during treatment for acute lymphoblastic leukemia (ALL), a blood cancer. It is for children ages 2–12 with ALL and their main caregivers. The study looks at how many families join, stay in the study, and take part in the planned sessions.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • The child is ages 2–12, and their main caregiver is ages 18–90.
  • The child has ALL, a type of blood cancer.
  • The child has finished induction, the first phase of treatment, but has not started maintenance, a later phase.
  • The child and caregiver can use English well.
  • The caregiver can give permission for the child to join the study.
  • The caregiver says they are involved in the child's cancer care.
  • The caregiver lives with the child at least half the time.
  • The child's main cancer care provider confirms the child can join.

Who can't join

  • The child's main cancer care provider has safety concerns about the child joining the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Children ages 2-12 years old and their primary caregiver ages 18-90 * Child diagnosed with acute lymphoblastic leukemia (ALL) * Child completed induction phase of therapy and not yet in maintenance phase of therapy * Primary caregiver and child English language proficient * Primary caregiver able to provide permission for child to participate in research * Primary caregiver identifies as being involved with child's oncology care * Primary caregiver lives with child at least 50% of the time * Primary oncology provider confirms child is eligible to participate Exclusion Criteria: * Primary oncology provider identifies safety concerns regarding the child's participation in the study.

Study sites (2)

KS

MO