An interventional study of PediCARE Intervention in Neuroblastoma, High-risk Neuroblastoma and Pediatric Cancer, sponsored by Dana-Farber Cancer Institute. Withdrawn. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-08-05.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Supportive care
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:
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.
634 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.
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Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
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Patients of all languages are eligible to participate.
Exclusion Criteria:
-Patient has transferred to ANBL1531 Arm E.
Participants 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.
Behavioral: PediCARE Intervention
Participants 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
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.
Also known as: PediCARE
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.
Time frame: At baseline and 3 months
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.
Time frame: 5 years
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.
Time frame: At baseline and 3-months
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data can be shared no earlier than 1 year following the date of publication
Access criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
No publications or documents are linked to this record.
This study is withdrawn, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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