Peer Navigation for Pediatric Cancer

(COMPRENDO Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by M.Paula Aristizabal, MD, MAS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Diego

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

No Placebo Group

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}

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;

Trial 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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dana Farber Cancer Institute/Boston Children's Hospital Boston, MA

Children's of Alabama Birmingham, AL

UCSD Benioff Children's Hospitals San Francisco, CA

Boston Children's Hospital Boston, MA

More Trial Locations

Who Is Running the Clinical Trial?

University of California, San Diego Lead Sponsor

Harvard University Collaborator

Dana-Farber Cancer Institute Collaborator

University of California, San Francisco Collaborator

University of Alabama at Birmingham Collaborator

National Cancer Institute (NCI) Collaborator

References

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

Adherence in the Cancer Care Setting: a Systematic Review of Patient Navigation to Traverse Barriers. [2022] Patient navigation is an evidence-based intervention involving trained healthcare workers who assist patients in assessing and mitigating personal and environmental factors to promote healthy behaviors. The purpose of this research is to systematically assess the efficacy of patient navigation and similar programs to improve diagnosis and treatment of diseases affecting medically underserved populations. A systematic review was performed by searching PubMed, MEDLINE, PsychINFO, and CINAHL to identify potential studies. Eligible studies were those containing original peer-reviewed research reports in English on patient navigation, community health workers, vulnerable and underserved populations, and healthcare disparity. Specific outcomes regarding patient navigator including the effect of the intervention on definitive diagnosis and effect on initiation of treatment were extracted from each study. The search produced 1428 articles, and 16 were included for review. All studies involved patient navigation in the field of oncology in underserved populations. Timing of initial contact with a patient navigator after diagnostic or screening testing is correlated to the effectiveness of the navigator intervention. The majority of the studies reported significantly shorter time intervals to diagnosis and to treatment with patient navigation. Patient navigation expedites oncologic diagnosis and treatment of patients in underserved populations. This intervention is more efficacious when utilized shortly after screening or diagnostic testing.

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] This study assessed the feasibility, acceptability and potential effects of True North Peer Navigation (PN)—a web-based peer navigation program for men with prostate cancer (PC) and their family caregivers. A one-arm, pre-post pilot feasibility study was conducted at two cancer centres in Canada. Participants were matched through a web-app with a specially trained peer navigator who assessed needs and barriers to care, provided support and encouraged a proactive approach to health for 3 months. Descriptive statistics were calculated, along with paired t-tests. True North PN was feasible, with 57.9% (84/145) recruitment, 84.5% (71/84) pre-questionnaire, 77.5% (55/71) app registration, 92.7% (51/55) match and 66.7% (34/51) post-questionnaire completion rates. Mean satisfaction with Peer Navigators was 8.4/10 (SD 2.15), mean program satisfaction was 6.8/10 (SD 2.9) and mean app usability was 60/100 (SD 14.8). At 3 months, mean ± SE patient/caregiver activation had improved by 11.5 ± 3.4 points (p = 0.002), patient quality of life by 1.1 ± 0.2 points (p

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] Patient navigation (PN) to improve cancer screening in low-income and racial/ethnic minority populations usually focuses on navigating for single cancers in community health center settings.

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

Effects of Peer-Led Interventions for Patients With Cancer: A Meta-Analysis [2019] To evaluate the effects of peer-led supportive interventions for patients with cancer. .

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

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. [2022] Patient navigation (PN) programs can improve cancer screening in underserved populations. PN may advance quality and equity of care by supporting individuals at increased risk of not receiving recommended care.

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] Cancer navigation improves access to support and reduces barriers to care; however, appropriate training of navigators is essential. We developed the TrueNTH Peer Navigation Training Program (PNTP), a competency-based, blended online/in-person course. In this study, we evaluate the feasibility, acceptability, and effectiveness of the PNTP among prostate cancer (PC) survivors (patients, caregivers).

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

Preliminary lessons learned from the "Native Navigators and the Cancer Continuum" (NNACC). [2021] This community-based participatory research (CBPR) study was based on patient navigation (Navigator) among three original sites: Colorado, Michigan, and South Dakota. During 2010, the study added two sites: the Comanche Nation and the Muscogee (Creek) Nation (Oklahoma). The intervention includes 24-h of a Navigator-implemented cancer education program that addresses the full continuum of cancer care. The partners include agreements with up to two local Native American organizations each year, called Memorandum Native Organizations, who have strong relationships with local American Indians. Family fun events are used to initiate the series of workshops and to collect baseline data and also to wrap up and evaluate the series 3 months following the completion of the workshop series. Evaluation data are collected using an audience response system (ARS) and stored using an online evaluation program. Among the lessons learned to date are: the Institutional Review Board processes required both regional and national approvals and took more than 9 months. All of the workshop slides were missing some components and needed refinements. The specifics for the Memorandum Native Organization deliverables needed more details. The ARS required additional training sessions, but once learned the Navigator use the ARS well. Use of the NACR website for a password-protected page to store all NNACC workshop and training materials was easier to manage than use of other online storage programs. The community interest in taking part in the workshops was greater than what was anticipated. All of the Navigators' skills are improving and all are enjoying working with the community.

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] Latino cancer survivors have lower survival rates for most cancers relative to non-Latino whites, including, colorectal, prostate, and breast. In addition, Latinos experience health disparities in both access to care and quality of care. Experts recommend providing psychosocial services as an integral part of quality cancer care; however, there continues to be a paucity of information on the efficacy of Patient Navigators (PNs) in linking Latino cancer survivors to appropriate psychosocial services. Redes En Acción: The National Latino Cancer Research Network partnered with LIVESTRONG Cancer Navigation Services Patient Navigation program (PN-LCNS) to provide an intervention to improve wellness and increase access to psychosocial services among non-metastatic Latino cancer survivors from Texas and Chicago using trained bilingual, bicultural PNs. The study design involved a mixed-methods approach in two phases. Phase I used a Community-Based Participatory Research (CBPR) approach wherein PNs engaged community partners who provide services to breast, colorectal and prostate Latino cancer survivors. Phase II was a randomized controlled trial (RCT) that evaluated the efficacy of combining PN-facilitated interventions with the culturally tailored and CBPR-informed PN-LCNS in 300 breast, prostate and colorectal Latino cancer survivors. Outcomes investigated were improvements in: 1) quality of life (QOL), both general and disease-specific, and; 2) treatment follow-up compliance. While limited work has addressed the psychosocial needs of Latino cancer survivors, culturally-competent interventions using PNs have potential to address these needs and significantly improve Latino cancer survivorship.

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] This study examines efficacy of a lay patient navigation (PN) program aimed to reduce time between a cancer abnormality and definitive diagnosis among racially/ethnically diverse and medically underserved populations of Tampa Bay, Florida.

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] Adolescents and young adults (AYA) with cancer desire peer support and require support programs that address their unique needs. This study investigated the need for, and barriers to, peer support and preferences for digital peer navigation among AYA. A cross-sectional survey was administered to AYA, diagnosed with cancer between the ages of 15-39, at a cancer center and through social media. Descriptive summary statistics were calculated. Participants (n = 436) were on average 31.2 years (SD = 6.3), 3.3 years since-diagnosis (SD = 3.8), and 65% (n = 218) were women. Over three-quaters (n = 291, 76.6%) desired peer support from cancer peers, but 41.4% (n = 157) had not accessed peer support. Main access barriers were: Inconvenience of in-person support groups (n = 284, 76.1%), finding AYA with whom they could relate (n = 268, 72.4%), and finding AYA-specific support programs (n = 261, 70.4%). Eighty-two percent (n = 310) desired support from a peer navigator through a digital app, and 63% (n = 231) were interested in being a peer navigator. Participants indicated a greater need for emotional (n = 329, 90.1%) and informational support (n = 326, 89.1%) than companionship (n = 284, 78.0%) or practical support (n = 269, 73.6%) from a peer navigator. Foremost peer matching characteristics were cancer-type (n = 329, 88.4%), specific concerns (n = 317, 86.1%), and age-at-diagnosis (n = 316, 86.1%). A digital peer navigation program was desired by over 80% of a large Canadian sample of AYA and could potentially overcome the barriers AYA experience in accessing peer support. The design of a peer navigation program for AYA should consider the matching characteristics and multidimensional support needs of AYA.