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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
450
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.
Children's of Alabama/University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGRady Children's Hospital San Diego/University of California San Diego Moores Cancer Center
San Diego, California, United States
RECRUITINGUniversity of California San Francisco Benioff Children's Hospitals
San Francisco, California, United States
RECRUITINGDana Farber Cancer Institute/Boston Children's Hospital
Boston, Massachusetts, United States
RECRUITINGAccrual
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.
Time frame: 12 weeks
Informed Consent Comprehension
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.
Time frame: 12 weeks
Voluntariness
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.
Time frame: 12 weeks
Decision-Making Self-Efficacy
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.
Time frame: 12 weeks
Decisional Regret
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.
Time frame: 12 weeks
Satisfaction with informed consent
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.
Time frame: 12 weeks
Trust in Research
Assesses individual's views on research studies.
Time frame: 12 Weeks
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