Multisite Implementation of COMPRENDO
- Conditions
- Pediatric Cancer
- Interventions
- Other: COMPRENDO Peer Navigation Intervention
- Registration Number
- NCT06055296
- Lead Sponsor
- University of California, San Diego
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
Clinicians and parents of children with cancer who have participated in IC discussion for a cancer therapeutic clinical trial.
Stakeholder
Clinicians and parents of children with cancer who have not participated in IC discussion for a cancer therapeutic clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description COMPRENDO Intervention COMPRENDO Peer Navigation Intervention Parent participants randomized to the intervention group will receive the COMPRENDO intervention that includes 2-4 visits led by a peer navigator across a 4-week period. Navigator visits will last about 16 - 60 minutes depending upon the needs and desires of the parent. Navigator sessions will be conducted in the parents' preferred language (either English or Spanish). Peer navigators will: * Discuss general concepts related to informed consent and treatment options, including standard of care and clinical trials. The navigator will not discuss specific medications with parents. * Attend the informed consent discussion parents have with their child's oncologist. * Help parents come up with questions when the oncologist talks about cancer treatment options. * Go over the consent forms. Answer questions parents may have to the best of their ability. * Meet with parents over 4 weeks. During these meetings, the navigator will facilitate decision-making.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Trial Locations
- Locations (4)
Children's of Alabama/University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Dana Farber Cancer Institute/Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
University of California San Francisco Benioff Children's Hospitals
🇺🇸San Francisco, California, United States
Rady Children's Hospital San Diego/University of California San Diego Moores Cancer Center
🇺🇸San Diego, California, United States