Multisite Implementation of COMPRENDO
ConditionPediatric Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
COMPRENDO Peer Navigation Intervention
Other interventionParents 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.
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: COMPRENDO InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Accrual
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksOther outcomes
1
Acceptability (parents)
Acceptability of COMPRENDO will be assessed in parents the 9-item Patient Satisfaction with Navigator (PSN-I). The score ranges from 9-45. A higher score on the PSN-I indicates higher satisfaction with their interpersonal relationship with the patient navigator. Our acceptability goal is \>80%
Time frame
Year 1-Year 52
Acceptability (clinicians)
Acceptability of COMPRENDO will be assessed in clinicians with the 6-item Intervention Credibility Scale. The score ranges from 4-20. Higher scores indicate greater acceptability. Our acceptability goal is \>80%
Time frame
Year 1-Year 53
Feasibility
Feasibility will be assessed by 4-item Feasibility of Intervention measure. The score ranges from 4-20. Higher scores indicate greater feasibility. Our feasibility goal is \>80%.
Time frame
Year 1-Year 54
Fidelity
Fidelity will be assessed by measuring adherence to the fidelity navigator checklist. Our fidelity goal is \>90%.
Time frame
Year 1-Year 5Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Diego
Lead sponsor
Dana-Farber Cancer Institute
Collaborator
University of California, San Francisco
Collaborator
University of Alabama at Birmingham
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov