The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network

NCT05454618 | Recruiting

• 2 other identifiers: U-DECIDENCI-2022-05119
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knowledge, Attitudes, Practice

Keywords

Parent; Pediatric Oncology Patients; Caregivers; Barriers to Enrollment on a Therapeutic Trial; Parent Navigator Program; Affiliate Network; Decision Making; Healthcare; Parent Engagement

Outcome Measures

Primary Outcomes (6)

• Sociodemographic characteristics of patients treated through the Affiliate network

  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.

  Day 1, or during a future contact (approximately 1 month)

• The correlation between social determinants and individual preferences among parents/LARs and the decision to enroll on a therapeutic clinical trial.

  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.

  Day 1, or during a future contact (approximately 2 months)

• 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.

  Qualitative data from semi-structured interviews will be transcribed and formally analyzed using thematic content analysis.

  Approximately 3 months after enrollment

• Differences between parent/LAR individual preferences as expressed to parent interviewers compared to non-parent interviewers

  Qualitative data will be formally analyzed using thematic content analysis comparing data collected by parent interviewers to data collected by non-parent interviewers.

  Approximately 3 months after enrollment

• Acceptability of a parent navigator program in the Affiliate network

  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)

  After initiation of the Parent Navigator Program approximately 4 years after start of study

• Feasibility of a parent navigator program in the Affiliate network

  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)

  After initiation of the Parent Navigator Program approximately 4 years after start of study

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All English or Spanish speaking parents/LARs of patients 0-18 years of age with newly diagnosed cancer in the Affiliate network.

You may qualify if:

• All English or Spanish speaking parents/LARs of patients 0-18 years of age with newly diagnosed cancer in the Affiliate network.

You may not qualify if:

• Parents of children with relapsed or recurrent disease, or those with benign neoplasms.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

• St. Jude Children's Research Hospital
• ClinicalTrials Open at St. Jude

MeSH Terms

Conditions

Behavior

Study Officials

• Dylan Graetz, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dylan Graetz, MD

CONTACT

866-278-5833; referralinfo@stjude.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: July 12, 2022
• Study Start: October 4, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)