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NeuroblastomaNCT06335745

PediCARE Health Equity Intervention in High-Risk Neuroblastoma

A study testing PediCARE Intervention in people with Neuroblastoma and High-risk Neuroblastoma, run by Dana-Farber Cancer Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma. Read more about this study

Who is it for?
Ages 0 to 17 years
What is being tested?
PediCARE Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2024to Sep 2028
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 0 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patient must have a new diagnosis of high-risk neuroblastoma.
  • Patient must be enrolled on APEC14B1 and must have consented to future contact on APEC14B1.
  • Patient must be enrolled on ANBL2131.
  • Patient aged 0-17 years at the time of consent to ANBL2131.
  • Patient must have opted-in to embedded optional ANBL2131 Household Survey.
  • Family screened positive for HMH or low-income on ANBL2131 Household Survey. *
Show all 10Show fewer
  • Patient has not yet initiated Induction Cycle 3 on ANBL2131.
  • Patient being treated at a U.S. site.
  • Patients of all languages are eligible to participate.
  • Eligibility based on Household Survey will be determined by central study team review. HMH exposure will be operationalized as the report of at least one of the following four concrete resource insecurities: (1) Food insecurity, (2) Housing Insecurity, (3) Utility Insecurity, (4) Transportation Insecurity. Low-income will be defined as reported annual household income of less than 200% federal poverty level (FPL).

Who cannot join

  • -Patient has transferred to ANBL1531 Arm E.

About this study

Official title: A Randomized Phase II Trial Evaluation of the Addition of the Pediatric Cancer Resource Equity (PediCARE) Health Equity Intervention to Usual Supportive Care for Children With Newly Diagnosed High-Risk Neuroblastoma

This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma.

The names of the intervention groups in this research study are:

  • Usual supportive care
  • PediCARE + usual supportive care
Read the detailed description

This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma.

Participants will be randomized into one of two groups: Usual Supportive Care vs. PediCARE + Usual Supportive Care. Randomization means a participant is placed into a group by chance.

Participation in this research study is expected to last 6-months.

It is expected about 130 people will participate in this research study.

Being tested
PediCARE Intervention
Keywords
Neuroblastoma, High-Risk Neuroblastoma, Disparities, Pediatric cancer, Financial stress, Poverty
Medical subject headings
Neuroblastoma, Neoplasms, Financial Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PediCARE InterventionBehavioural

    Also called PediCARE

    A household material hardship intervention with monthly, direct provision of groceries and transportation. Resources will be centrally administered by the Dana-Farber Cancer Institute study team.

Study groups in NCT06335745
Study groupRoleWhat they receive
Arm 1: PediCARE + Usual Supportive Care ExperimentalExperimentalParticipants will be randomized in a 1:1 ratio and stratified according to treatment group and household material hardship (HMH) severity group and participant parents/guardians will complete: * Remote baseline visit with introduction to PediCARE intervention by central study team * Parent completion of baseline survey. * Receipt of monthly PediCARE resource provisions x 6-months. * Parent completion of 3-month follow-up survey. * Parent completion of 6-month follow up survey and end of intervention period.
Receives: Behavioral: PediCARE Intervention
Arm 2: Usual Supportive Care ArmNo interventionParticipants will be randomized in a 1:1 ratio and stratified according to treatment group and HMH severity group and participant parent/guardians will complete: * Remote baseline visit * Parent completion of baseline survey. * Receipt of site-specific routine supportive care x6-month study period * Parent completion of 3-month follow-up survey * Parent completion of 6-month follow-up survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Kessler-6 Psychological Distress Scale Score

    As measured by the Kessler-6 Psychological Distress Scale (K6), a 6-item measure for the level of psychological distress in the past month. Responses are scored on a 5-point Likert scare with answers ranging from 0 "None of the time" to 4 "All of the time," and with a total score range of 0 - 4. Scores > or = 7 suggest "high" distressed and those > or = 13 meet criteria for serious or debilitating psychological distress. A t-test of differences in mean change scores of parent/guardian psychological distress from T1 (baseline) to T2 (3 months) will be used to compare across PediCARE and usual supportive care arms. The distribution of parent psychological distress scores across PediCARE and usual supportive care arms will also be descriptively characterized. The descriptive analyses will be intention-to-treat, defined as all randomized participants with at least one post-baseline contact or follow-up measure.

    Measured: At baseline and 3 months

Secondary outcomes (2)

  1. Proportion of Enrolled Participants (Feasibility)

    Feasibility of conducting a centrally-administered companion health equity intervention study among COG trial-enrolled participants will be described using proportions and 95% confidence intervals. Successful feasibility is defined as >75% consent to participation and randomization and <20% attrition. Feasibility metrics will be collected and monitored in real time throughout the duration of the study (about 5 years). An interim analysis for early stopping will also be conducted halfway through accrual (n=40 participants) to assess futility of the feasibility endpoint.

    Measured: 5 years

  2. Change in Mean Household Material Hardship (HMH) Score

    Household Material Hardship (HMH) information will via parent/guardian-completed survey instruments using standardized measures of housing, food, utility, and transportation insecurity. HMH scores will be calculated based on parent/guardian responses and will range from 0-4 based on the number of discrete areas of insecurity endorsed by participants. A t-test of differences in mean HMH change scores from T1 (baseline) to T2 (month 3) will be used to compare across PediCARE and usual supportive care arms. Investigators will also characterize the distribution between T1 and T2 HMH scores across PediCARE and usual supportive care arms on the ordinal scale from 0 to 4 using a chi-square test.

    Measured: At baseline and 3-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2024
  2. Study startSep 2024 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Why it stopped: Study halted prematurely, prior to enrollment of first participant

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06335745
Sponsor's protocol ID
24-066
Status last verified
Aug 2024
First submitted
14 Mar 2024
Last updated
5 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the study PI Dr. Kira Bona. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A study testing PediCARE Intervention in people with Neuroblastoma and High-risk Neuroblastoma, run by Dana-Farber Cancer Institute.

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 10 inclusion and 1 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: withdrawn, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 withdrawn before enrolling participants, so there are no results.

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 Kessler-6 Psychological Distress Scale Score (time frame: At baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06335745.

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 5 Aug 2024.

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