Peer Navigation for Pediatric Cancer

(COMPRENDO Trial)

Recruiting at 7 trial locations

Overseen By M.Paula Aristizabal, MD, MAS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Second malignancy, Relapse, Non-Hispanic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

450 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It seems to focus on the role of peer navigation in clinical trials rather than medication changes.

What data supports the effectiveness of the COMPRENDO Peer Navigation Intervention treatment for pediatric cancer?

Research shows that peer navigation programs, like the COMPRENDO Peer Navigation Intervention, can help improve cancer care by reducing the time to diagnosis and treatment, especially in underserved populations. Peer-led interventions have been effective in providing support and improving the quality of life for cancer patients. ^{1 2 3 4 5}

Is the Peer Navigation intervention safe for use in humans?

The studies on peer navigation interventions, such as True North Peer Navigation for prostate cancer patients, indicate that these programs are generally well-received and feasible, with no specific safety concerns reported. However, these studies primarily focus on feasibility and satisfaction rather than detailed safety data. ^{2 6 7 8 9}

How is the COMPRENDO Peer Navigation Intervention treatment different from other treatments for pediatric cancer?

The COMPRENDO Peer Navigation Intervention is unique because it focuses on providing peer support and navigation for children with cancer, helping them and their families overcome barriers to care and access necessary support, unlike traditional medical treatments that focus solely on the physical aspects of cancer. ^{1 2 4 6 10}

Research Team

M.Paula Aristizabal, MD, MAS

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for Hispanic parents or guardians with children aged 0-17 who have a new diagnosis of cancer or similar disease and are eligible for a therapeutic clinical trial. Participants must understand English or Spanish, agree to discuss informed consent, and not be planning to transfer care soon.

Inclusion Criteria

- are a Hispanic parent/primary legal guardian;

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:

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

Exclusion Criteria

- not Hispanic.

Stakeholder Exclusion Criteria:

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

COMPRENDO Intervention

Parent participants receive the COMPRENDO intervention led by a peer navigator, including discussions on informed consent and treatment options over 2-4 visits.

4 weeks

2-4 visits (in-person)

Usual Care

Parents participate in an informed consent conference with the oncologist to discuss treatment options for the child.

4 weeks

Follow-up

Participants are monitored for satisfaction with informed consent and other outcomes.

12 weeks

Treatment Details

Interventions

• COMPRENDO Peer Navigation Intervention

Trial Overview COMPRENDO tests a peer-navigation intervention against usual care in pediatric cancer cases. It aims to improve the number of families participating in trials and enhance informed consent outcomes through four visits by trained navigators.

Participant Groups

Group I: COMPRENDO Intervention Experimental Treatment 1 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.

Group II: Usual Care Active Control 1 Intervention

Parents will participate in an informed consent conference with the oncologist to discuss treatment options for the child as per each institution's procedure.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Harvard University

Collaborator

Trials

237

Recruited

588,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Patient navigation significantly reduces the time it takes for patients in underserved populations to receive a diagnosis and start treatment for cancer, based on a systematic review of 16 studies.

The effectiveness of patient navigation is enhanced when initial contact occurs soon after diagnostic or screening tests, highlighting the importance of timely intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence in the Cancer Care Setting: a Systematic Review of Patient Navigation to Traverse Barriers. Bush, ML., Kaufman, MR., Shackleford, T.[2022]

The True North Peer Navigation program for men with prostate cancer and their caregivers demonstrated high feasibility and acceptability, with a recruitment rate of 57.9% and a post-questionnaire completion rate of 66.7%.

Participants showed significant improvements in activation, quality of life, and support needs after 3 months, indicating the program's potential effectiveness, which warrants further investigation in a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Peer Navigation for Men with Prostate Cancer and Their Family Caregivers: A Pilot Feasibility Study. Bender, JL., Flora, PK., Soheilipour, S., et al.[2023]

A randomized clinical trial involving 1612 patients showed that patient navigation (PN) significantly improved cancer screening rates for breast, cervical, and colorectal cancers, with completion rates of 10.2% in the PN group compared to 6.8% in the control group.

The PN intervention was particularly effective, leading to higher screening completion rates across all cancer types: breast (23.4% vs 16.6%), cervical (14.4% vs 8.6%), and colorectal (13.7% vs 7.0%), indicating that integrating PN into healthcare can enhance cancer screening in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigation for Comprehensive Cancer Screening in High-Risk Patients Using a Population-Based Health Information Technology System: A Randomized Clinical Trial. Percac-Lima, S., Ashburner, JM., Zai, AH., et al.[2022]

A systematic review of 18 studies, including 16 randomized controlled trials, evaluated the effects of peer-led supportive interventions for cancer patients, focusing on various outcomes like emotional health and quality of life.

The results indicate a need for more rigorous, theory-based evaluations to confirm the effectiveness of these peer-led interventions in cancer care, suggesting that while promising, further research is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Peer-Led Interventions for Patients With Cancer: A Meta-Analysis Lee, MK., Suh, SR.[2019]

In a study involving 222 patients, those who received patient navigation (PN) for cancer screening reported significantly higher satisfaction with their overall medical care compared to those who did not receive PN (71.0 vs 66.8).

The results suggest that PN programs can enhance patient satisfaction, particularly for individuals at high risk of not adhering to recommended cancer screening, indicating a potential benefit for improving care quality and equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. Hermann, EA., Ashburner, JM., Atlas, SJ., et al.[2022]

The TrueNTH Peer Navigation Training Program (PNTP) was found to be highly acceptable and effective for training prostate cancer survivors as peer navigators, with a satisfaction score of 9.4 out of 10 and a high usability rating of 84.5 out of 100.

Participants showed significant improvements in understanding learning objectives, self-efficacy, and eHealth literacy, indicating that the program effectively enhanced their knowledge and confidence in supporting others with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training prostate cancer survivors and caregivers to be peer navigators: a blended online/in-person competency-based training program. Bender, JL., Flora, PK., Milosevic, E., et al.[2021]

The community-based participatory research study successfully implemented a 24-hour cancer education program across multiple Native American sites, highlighting strong community interest and engagement in the workshops.

The study identified key logistical challenges, such as lengthy Institutional Review Board approval processes and the need for improved training and materials, which are essential for enhancing the effectiveness of future Navigator-led interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary lessons learned from the "Native Navigators and the Cancer Continuum" (NNACC). Burhansstipanov, L., Krebs, LU., Watanabe-Galloway, S., et al.[2021]

Latino cancer survivors face significant health disparities, including lower survival rates and access to care compared to non-Latino whites, highlighting the need for targeted interventions.

A study involving 300 Latino cancer survivors demonstrated that using trained bilingual and bicultural Patient Navigators can effectively improve quality of life and treatment follow-up compliance, suggesting that culturally-competent support is crucial for enhancing cancer survivorship in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving quality of life among latino cancer survivors: Design of a randomized trial of patient navigation. Ramirez, AG., Gallion, KJ., Perez, A., et al.[2021]

The lay patient navigation program did not significantly reduce the time to diagnostic resolution for cancer abnormalities among 1,267 participants, indicating that it may not be effective in expediting cancer diagnosis in diverse and underserved populations.

While a higher percentage of navigated patients achieved diagnostic resolution within 180 days (74.5% vs. 68.5% in the control group), this difference was not statistically significant, suggesting that further research is needed to evaluate the effectiveness of patient navigation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cluster randomized trial evaluating the efficacy of patient navigation in improving quality of diagnostic care for patients with breast or colorectal cancer abnormalities. Wells, KJ., Lee, JH., Calcano, ER., et al.[2023]

A survey of 436 adolescents and young adults (AYA) with cancer revealed that 76.6% desired peer support, but 41.4% had not accessed it due to barriers like inconvenience and difficulty finding relatable peers.

Over 80% of participants expressed interest in a digital peer navigation program, highlighting the need for emotional and informational support tailored to their specific cancer type and concerns, which could help overcome existing access barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer Support Needs and Preferences for Digital Peer Navigation among Adolescent and Young Adults with Cancer: A Canadian Cross-Sectional Survey. Bender, JL., Puri, N., Salih, S., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Adherence in the Cancer Care Setting: a Systematic Review of Patient Navigation to Traverse Barriers. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Web-Based Peer Navigation for Men with Prostate Cancer and Their Family Caregivers: A Pilot Feasibility Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Patient Navigation for Comprehensive Cancer Screening in High-Risk Patients Using a Population-Based Health Information Technology System: A Randomized Clinical Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Peer-Led Interventions for Patients With Cancer: A Meta-Analysis [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Training prostate cancer survivors and caregivers to be peer navigators: a blended online/in-person competency-based training program. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Preliminary lessons learned from the "Native Navigators and the Cancer Continuum" (NNACC). [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Improving quality of life among latino cancer survivors: Design of a randomized trial of patient navigation. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A cluster randomized trial evaluating the efficacy of patient navigation in improving quality of diagnostic care for patients with breast or colorectal cancer abnormalities. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Peer Support Needs and Preferences for Digital Peer Navigation among Adolescent and Young Adults with Cancer: A Canadian Cross-Sectional Survey. [2022]