NCT05454618 · St. Jude Children's Research Hospital
The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
What this study is about
The focus of this study is to learn about the factors that parents consider when making a decision for their child to participate or not in a clinical treatment research study.
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The focus of this study is to learn about the factors that parents consider when making a decision for their child to participate or not in a clinical treatment research study.
Primary outcome measures
Sociodemographic characteristics of patients treated through the Affiliate network
Time frame: Day 1, or during a future contact (approximately 1 month)
Sociodemographic information will be analyzed descriptively. Full home address data will be geocoded to generate area deprivation information for each participant. Cumulative hardship will be calculated using previously established measures and scoring.These scores will be analyzed descriptively. Exploratory comparative analysis will be done to determine if there are differences between the sub-group of patients eligible for clinical trial enrollment versus those who are not eligible.
The correlation between social determinants and individual preferences among parents/LARs and the decision to enroll on a therapeutic clinical trial.
Time frame: Day 1, or during a future contact (approximately 2 months)
Data collected from survey #1 for this subgroup of patients will be used to statistically describe the sociodemographic information for patients who are eligible to enroll on a clinical trial and comparative analysis will be conducted to examine differences and potential associations between the group of parents/LARs who do enroll their child on a clinical trial, and those who do not. Responses from survey #2 will be analyzed descriptively to provide an overall understanding of decision-making preferences and roles, as well as clinical trial attitudes amongst parents/LARs whose children are eligible for a clinical trial. Comparative analysis will be used to determine if there are differences in these individual preference items between the group of parents/LARs whose children do enroll on a clinical trial, and those who do not.
The correlation between social determinants, decision-making factors, trial related attitudes among parents/LARs and the decision to enroll or not enroll on a therapeutic clinical trial.
Time frame: Approximately 3 months after enrollment
Qualitative data from semi-structured interviews will be transcribed and formally analyzed using thematic content analysis.
Differences between parent/LAR individual preferences as expressed to parent interviewers compared to non-parent interviewers
Time frame: Approximately 3 months after enrollment
Qualitative data will be formally analyzed using thematic content analysis comparing data collected by parent interviewers to data collected by non-parent interviewers.
Acceptability of a parent navigator program in the Affiliate network
Time frame: After initiation of the Parent Navigator Program approximately 4 years after start of study
Acceptability: we will determine that the navigator program is acceptable if the median score on the acceptability scale is \> 3. Likert scale 1-5 will be used (1=Completely disagree, 2=Disagree, 3=Neither, 4=Agree, 5=Completely agree)
Feasibility of a parent navigator program in the Affiliate network
Time frame: After initiation of the Parent Navigator Program approximately 4 years after start of study
Feasibility: we will determine that the navigator program is feasible if the median score on the feasibility scale is \> 3. Likert scale 1-5 will be used (1=Completely disagree, 2=Disagree, 3=Neither, 4=Agree, 5=Completely agree)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- All English or Spanish speaking parents/LARs of patients 0-18 years of age with newly diagnosed cancer in the Affiliate network.
Exclusion criteria
- Parents of children with relapsed or recurrent disease, or those with benign neoplasms.
Where
- Memphis, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 20, 2026 · Source of record for eligibility and locations