Multisite Implementation of COMPRENDO

Pediatric Cancer Clinical Trial

— COMPRENDO  

Official title:

Multisite Implementation of COMPRENDO (ChildhOod Malignancy Peer REsearch NavigatiOn) to Improve Participation of Hispanic Children in Cancer Clinical Trials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06055296
• Other study ID #: 808092
• Secondary ID: 1R01CA279945-01
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: M.Paula Aristizabal, MD, MAS
• Phone: 858-966-5811
• Email: paristizabal[@]rchsd.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 30, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Participants (n˜400) will be parents of Hispanic children (0-17 years) with newly diagnosed cancer or cancer-like disease (histiocytic disorders or myelodysplastic syndromes) and eligible for a therapeutic clinical trial who meet the following inclusion criteria:

• are a Hispanic parent/primary legal guardian;

• has a child aged 0 to 17 y with a new diagnosis of cancer or cancer-like disease (histiocytic disorders or myelodysplastic syndromes);

• has a child who is eligible for a therapeutic cancer clinical trial;

• will participate in an informed consent discussion for the therapeutic clinical trial;

• has an understanding of written and spoken English or Spanish;

• has signed the consent form for the proposed COMPRENDO study.

Parent Exclusion Criteria:

• second malignancy/relapse;

• diagnosed at an outside institution;

• potential transfer of care to another institution within the next 4 months;

• previously on a clinical trial;

• does not understand written and spoken English or Spanish;

• not Hispanic.

Stakeholder Inclusion Criteria:

Clinicians and parents of children with cancer who have participated in IC discussion for a cancer therapeutic clinical trial.

Stakeholder Exclusion Criteria:

Clinicians and parents of children with cancer who have not participated in IC discussion for a cancer therapeutic clinical trial.

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Other:
• COMPRENDO 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.

Locations

Country	Name	City	State
United States	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	Rady Children's Hospital San Diego/University of California San Diego Moores Cancer Center	San Diego	California
United States	University of California San Francisco Benioff Children's Hospitals	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Diego	Dana-Farber Cancer Institute, National Cancer Institute (NCI), University of Alabama at Birmingham, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (4)

Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. — View Citation

Freeman HP. Patient navigation: a community based strategy to reduce cancer disparities. J Urban Health. 2006 Mar;83(2):139-41. doi: 10.1007/s11524-006-9030-0. No abstract available. — View Citation

Moullin JC, Dickson KS, Stadnick NA, Rabin B, Aarons GA. Systematic review of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. Implement Sci. 2019 Jan 5;14(1):1. doi: 10.1186/s13012-018-0842-6. — View Citation

Palinkas LA, Mendon SJ, Hamilton AB. Innovations in Mixed Methods Evaluations. Annu Rev Public Health. 2019 Apr 1;40:423-442. doi: 10.1146/annurev-publhealth-040218-044215. Epub 2019 Jan 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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%	Year 1-Year 5
Other	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%	Year 1-Year 5
Other	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%.	Year 1-Year 5
Other	Fidelity	Fidelity will be assessed by measuring adherence to the fidelity navigator checklist. Our fidelity goal is >90%.	Year 1-Year 5
Primary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks