Clinical trial NCT05454618: The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Official title: U-DECIDE: The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Aim 1:

* To describe the sociodemographic characteristics of patients treated through the Affiliate network, including those that are eligible for a therapeutic treatment study as well as those that are not. This aim will be accomplished using a survey based on previously validated tools measuring demographics, social determinants of health, and material hardship.

Following consent, the study team research assistant will verbally administer survey #1 to each participant or email the unique electronic link for each participant to complete. If necessary, survey #1 may be administered at a later date mutually agreed upon by the interviewer and the participant. Survey #1 contains questions on race, ethnicity, family structure, marital status, household income, and education level of parents, as well as previously validated instruments assessing cumulative hardship through assessments of housing, food accessibility, and utilities. Address information on both participants and non-participants will also be collected.

Aim 2:

* To examine the associations between social determinants, decision-making factors, trial-related attitudes, and additional individual preferences among parents/LARs of newly diagnosed pediatric oncology patients in the Affiliate network and the decision to enroll or not enroll on a therapeutic clinical trial. This aim will be accomplished through a convergent mixed-method design and include an additional exploratory qualitative sub-aim assessing potential differences in interviews conducted by parent versus non-parent interviewers.

Aim 2a:

* Quantitatively explore the relationship between social determinants and individual preferences among parents/LARs and the decision to enroll on a therapeutic clinical trial.

Parents/LARs who meet inclusion criteria for Aim 1, and are eligible for a clinical trial, will be included for potential participation. Data collected will include a subset of data collected for Aim 1, as well as data from a second survey (survey #2) focused on decision making and clinical trial attitudes. Additional items assessed with survey #2 relate to clinical trial attitudes and pediatric research participation including measures assessing access, risks of enrollment, attitudinal barriers, financial and social concerns, as well as trust/mistrust. Following consent, the study team research assistant will verbally or electronically administer survey #2 to each participant. If eligibility for clinical trial enrollment is known at the time of administration of survey #1, survey #2 may be administered at the same time to eligible parents/LARs. Otherwise, parents/LARs of children who are eligible for a clinical trial will be asked to complete survey #2 once this eligibility is confirmed and at a time mutually agreed upon by the participant and the research assistant.

In addition to the data collected from participants as described above, data from the affiliate log, including provider described reasons for non-enrollment on a clinical trial as applicable, will be collected.

Aim 2b:

* Qualitatively determine the relationship 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.

A subset of parents/LARs of children eligible for clinical trial enrollment will be approached to participate in a semi-structured interview. Participants for this qualitative sample will include a group of parents/LARs who decided to enroll, as well as a group of parents/LARs who chose not to enroll their child on a clinical trial.

Interviews will be conducted in either English or Spanish by bilingual interviewers using a semi-structured interview guide. These interviews will explore parents/LARS' general feelings about medical research including reasons they would or would not want their child to be enrolled in a research study, as well as more in-depth questions regarding their own experience talking to their child's oncologist about the clinical trial and their decision-making process around enrollment. Interviews will be conducted over the phone or a video-conferencing program platform by a trained qualitative interviewer and audio-recorded

Sub-aim 2b:

* Qualitatively explore differences between parent/LAR individual preferences as expressed to parent interviewers compared to non-parent interviewers.

Participants for this qualitative sample will be purposefully selected to mirror the qualitative sample included in aim 2b. Semi-structured interviews will be conducted in English or Spanish by bilingual parent interviewers. These interviews will be conducted over the phone or a video-conferencing program platform and audio-recorded. Parent interviewers will receive the same qualitative interview training as non-parent interviewers. The first portion of the interview guide will match the one used in investigator-led interviews. Additional questions will be added to the parent-interviewer guide including questions that address the participants comfort discussing clinical trial enrollment with parent interviewers.

Aim 3:

* To assess acceptability and feasibility of a parent navigator program within the Affiliate network.

All parents who choose to enroll their child in a clinical trial will be eligible for enrollment in the parent navigator program. The aim is to recruit and train 1-2 parent navigators at each affiliate site. Parent navigators will be recruited and trained based on the established process for the parent mentor program at St. Jude. Recruitment and training will begin in year 1 and continue through year 3 of the study.

Newly diagnosed parents/LARs whose children are eligible for enrollment on a therapeutic clinical trial will be offered enrollment in the pilot intervention. Once enrolled, parent navigators will initiate contact with parents of newly diagnosed patients first through a phone call or text message. Newly diagnosed parents/LARs will be paired with navigators for 6 weeks. Two interactions are proposed: one within weeks 1-3 of diagnosis/enrollment and the second during weeks 4-6, however, the navigator will be available for additional interactions as necessary and will contact the newly diagnosed parent/LAR approximately every 10 days. During this period, interactions between parents and navigators will be focused on initial decision-making around clinical trial enrollment, concerns regarding the clinical trial, confusion around elements of the clinical trial, and referrals to aid in information exchange.

After initiating contact with a newly diagnosed parent/LAR, parent navigators will complete an encounter form including a baseline questionnaire of parent and patient data as well as potential barriers to clinical trial enrollment. Following completion of the six weeks of engagement, both the parent- navigator and the parent/LAR will be asked to complete a final questionnaire. The parent questionnaire will include items related to satisfaction with the program and and adapted to focus on clinical trial enrollment, as well as a brief instrument previously validated to assess acceptability and navigators will complete a questionnaire assessing acceptability and feasibility of the program.

Eligibility criteria: 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.

Primary outcomes:
measure: Sociodemographic characteristics of patients treated through the Affiliate network
timeFrame: Day 1, or during a future contact (approximately 1 month)
measure: The correlation between social determinants and individual preferences among parents/LARs and the decision to enroll on a therapeutic clinical trial.
timeFrame: Day 1, or during a future contact (approximately 2 months)
measure: 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.
timeFrame: Approximately 3 months after enrollment
measure: Differences between parent/LAR individual preferences as expressed to parent interviewers compared to non-parent interviewers
timeFrame: Approximately 3 months after enrollment
measure: Acceptability of a parent navigator program in the Affiliate network
timeFrame: After initiation of the Parent Navigator Program approximately 3 years after start of study
measure: Feasibility of a parent navigator program in the Affiliate network
timeFrame: After initiation of the Parent Navigator Program approximately 3 years after start of study
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Dylan Graetz, MD
role: PRINCIPAL_INVESTIGATOR
References: