Pediatric Cancer
Conditions
Keywords
Research Literacy, Cancer Disparities, Minority Clinical Trial Accrual, Patient Navigation
Brief summary
COMPRENDO (ChildhOod Malignancy Peer Research NavigatiOn) is a multi-site randomized clinical trial (RCT) that uses a Hybrid Type 1 design, to test the effects of a clinical intervention on patient-level outcomes, while exploring multilevel implementation factors that can inform real-world setting implementation. This study will test the impact of COMPRENDO, a peer-navigation intervention, vs. usual care on accrual to childhood cancer therapeutic clinical trials and parental informed consent outcomes. COMPRENDO will be delivered by trained peer navigators in 4 visits. A mixed methods (surveys, individual interviews) implementation evaluation will examine implementation factors that can inform the use of peer navigation in clinical practice, integrating data from clinicians, navigators, administrators, and parents pre and post the RCT.
Detailed description
Aim 1: Test the effectiveness of COMPRENDO vs. usual care to increase clinical trial accrual in a multisite RCT. Aim 2: Determine the impact of COMPRENDO vs. usual care on parental outcomes (informed consent, comprehension, voluntariness, decision-making self-efficacy, satisfaction with informed consent and decisional regret). Aim 3: Evaluate multisite implementation of COMPRENDO, focusing on acceptability, feasibility, and fidelity. We will use mixed methods with a minimum of 50 stakeholders: 22 clinicians, (17 oncologists, 3 psychologists, 2 social workers), 4 navigators, 4 administrators and 20 parents to identify implementation factors. Within each site, eligible participants will be randomized 1:1 to the intervention vs. usual care (informed consent discussion with the oncologist only), resulting in ≈200 participants randomized to each arm.
Interventions
OTHERCOMPRENDO Peer Navigation Intervention
Parents randomized to the intervention, COMPRENDO, will receive culture, language, and health literacy-concordant pre-accrual, accrual, and post-accrual activities in person led by a peer navigator for up to 4 weeks. Visit 1 (V1) will provide anticipatory guidance and education on a) general concepts of pediatric cancer research (standard of care, clinical trials, randomization); b) informed consent/assent, research affiliations (e.g., Children's Oncology Group); c) clinical trial types (therapeutic, non-therapeutic); d) voluntariness; and e) "frequently asked questions", resources. Navigators will follow a script supported by culture, language and health-literacy concordant handouts and graphic materials, decision aids, and short video-clips. Navigators also provide support with decision-making and answer parents' questions. Three follow-up peer navigator visits (V2, V3, V4) over 4 weeks are tailored to the parents' needs.
Sponsors
University of California, San Diego
Dana-Farber Cancer Institute
University of California, San Francisco
University of Alabama at Birmingham
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
We will use a Hybrid 1 design that combines a randomized effectiveness trial and a mixed methods observational implementation evaluation. Hybrid designs assess both clinical effectiveness and implementation, thus bridging the gap between two research areas.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Non-Stakeholder/Stakeholder Parent Eligibility criteria: A parent/legal guardian who has a Hispanic child aged 0 to 17y with a new diagnosis of cancer, has a child who is eligible for a therapeutic cancer clinical trial, will participate in an informed consent discussion for the therapeutic clinical trial, understands written and spoken English or Spanish, and has signed the consent form for the proposed COMPRENDO study. Participants will not be eligible if their child has second malignancy/relapse, was diagnosed at an outside institution, has potential transfer of care, was previously on a clinical trial Stakeholder Clinician/Navigator/Administrator Clinicians, navigators and administrators who work at each site, are involved in treating pediatric patients and who are involved in the informed consent conference for clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accrual | 12 weeks | Measured by a higher proportion of children enrolled in therapeutic trials whose parents are randomized to COMPRENDO vs. the proportion of children enrolled in therapeutic trials whose parents are randomized to usual care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Informed Consent Comprehension | 12 weeks | Informed Consent Comprehension will be assessed using the Quality of Informed Consent (QuIC), a valid 20-item instrument that assesses objective understanding of the basic elements of Informed Consent. The summary score potentially ranges from 0 to 100. The highest the summary score, the highest the comprehension. |
| Voluntariness | 12 weeks | Voluntariness will be assessed using the Decision-making Control Instrument (DMCI), a 9-item, Likert-format scale, which is used in parents who make decisions about research, including cancer. The instrument score range from 9-54, the higher score equals to higher perception of voluntariness. |
| Decision-Making Self-Efficacy | 12 weeks | Decision-Making Self Efficacy will be assessed with the 11-item Decision Self-Efficacy Scale (DSE), a 5-point scale which measures self-confidence in decision making (shared decision making, decision conflict, feeling informed and supported). Score range from 0 \[not at all confident\] to 100 \[very confident\]. A score of 0 means extremely low self efficacy and a score of 100 means extremely high self efficacy. |
| Decisional Regret | 12 weeks | The 5-item Decisional Regret Scale will measure regret after health-care decisions. Score range is from 0 to 100. A score of 0 means no regret; a score of 100 means high regret. |
| Satisfaction with informed consent | 12 weeks | Satisfaction with informed consent will be measured with a 24-item satisfaction questionnaire to evaluate parents' perceptions of overall satisfaction with the IC discussion (satisfaction with ICs explanation, quantity of information, utility of the IC, affective responses).The score ranges from 7-21. A score of 7 meaning least satisfied; a score of 21 most satisfied. |
| Trust in Research | 12 Weeks | Assesses individual's views on research studies. |
Countries
United States
Contacts
CONTACTM.Paula Aristizabal, MD, MAS
PRINCIPAL_INVESTIGATORM.Paula Aristizabal, MD, MAS
University of California, San Diego
Outcome results
None listed