Needs Navigation for Caregivers of Young Adults with Cancer

(Cope-CAYAC Trial)

Overseen By Melissa Beauchemin, PhD, MSN,CPNP-PC, CPO

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Previous study participation, Hospice, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on helping caregivers of young adults with cancer manage their challenges. It aims to reduce health-related social issues and improve outcomes for adolescent and young adult (AYA) cancer survivors through a needs navigation program, a supportive intervention. Participants will receive connections to community resources, financial education, and vocational support over six months. The trial seeks caregivers of young adults aged 15-26 who have been diagnosed with cancer within the last year and are not in end-of-life care. As an unphased trial, this study provides caregivers with access to valuable resources and support tailored to their unique needs.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this needs navigation intervention is safe for caregivers of young adults with cancer?

Research has shown that programs assisting caregivers of teens and young adults with cancer are generally safe. One study found that programs addressing financial and health-related needs were helpful and well-received. Participants often find these programs useful for connecting to community resources and support services.

Reports of negative effects from these programs do not exist. Instead, they often help people better manage financial and social challenges, suggesting the programs are well-tolerated. No harmful events have been noted, making them a safe choice for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the needs navigation intervention for caregivers of young adults with cancer because it offers a comprehensive support system that isn't typically available in standard care. Unlike traditional treatments that focus solely on the patient, this intervention connects caregivers with community partners for financial education and provides vocational support tailored to their needs. It aims to reduce the stress and challenges caregivers face by offering easily accessible resources and ongoing consultation over six months, potentially improving their quality of life and their ability to support their loved ones.

What evidence suggests that the needs navigation intervention is effective for caregivers of young adults with cancer?

Research has shown that "needs navigation interventions" effectively support caregivers of young adults with cancer. In this trial, participants will receive the Needs Navigation Intervention, which reduces caregiver stress through education, emotional support, and resource connections. These interventions help patients and families access necessary care by overcoming obstacles. By providing caregivers with the right tools and support, these programs aim to improve care outcomes and reduce disparities in care quality. This approach is designed to enhance caregivers' confidence and support in managing their loved one's care needs. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for caregivers of adolescent and young adult (AYA) cancer survivors. It's designed to help them manage unmet health-related social needs. Specific eligibility details are not provided, but typically participants must be directly involved in the care of an AYA with cancer.

Inclusion Criteria

I am the caregiver or financially responsible for a young person with cancer.

I am aged 15-26, speak English or Spanish, and am within 1 year post-treatment without cancer returning.

Exclusion Criteria

Unable to complete financial survey questions or contraindicated (as outlined in Protection of Human Subjects)

Dyad with younger AYAs who are enrolled on hospice or receiving other end-of-life care

Dyad with caregiver or younger AYA that previously participated in study AAAU2405

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Needs Navigation Intervention

Participants receive connection to community partners with financial education and resources, and a vocational navigation and support consultation for caregivers

6 months

Regular consultations with community partners

Follow-up

Participants are monitored for financial wellness and intervention effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Needs navigation intervention

Trial Overview The study is testing a 'needs navigation intervention' which aims to support caregivers by addressing their specific challenges and reducing disparities in outcomes for AYAs with cancer. The intervention has been developed with experts and will now be tested in a real-world setting.

How Is the Trial Designed?

Group I: Needs Navigation Intervention Experimental Treatment 1 Intervention

Individuals who screen positive will all move forward to receive this intervention. This includes connection to community partners with financial education and easily accessible resources, and a vocational navigation and support consultation for caregivers for 6-months.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

The Oncology Interactive Navigator™ (OIN) was found to be a valuable resource for 151 individuals newly diagnosed with colorectal cancer or melanoma, helping them access important cancer information and support during the critical early stages of their diagnosis.

Qualitative interviews with 20 participants revealed that the OIN™ significantly enhanced their understanding of cancer, improved communication with healthcare providers, and helped them prepare for medical consultations, indicating its potential as an effective tool for psychosocial adjustment in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual navigation in colorectal cancer and melanoma: an exploration of patients' views. Loiselle, CG., Peters, O., Haase, KR., et al.[2021]

The patient navigation intervention (Una Mano Amiga) did not significantly reduce the time from cancer diagnosis to treatment initiation, with an average of 59.6 days for participants compared to 47.1 days in non-intervention data.

Despite the lack of a significant reduction in treatment initiation time, patients and family members reported high satisfaction with the intervention, indicating potential benefits that warrant further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Una Mano Amiga: Pilot Test of a Patient Navigator Program for Southwest New Mexico. Vilchis, H., Onstad, LE., Benavidez, R., et al.[2020]

A study of 282 caregivers of adolescents and young adults with cancer revealed that the most common unmet needs were related to worries about the future and the need for information, highlighting significant emotional stress among caregivers.

Approximately 40% of caregivers experienced moderate to severe anxiety and depression, indicating a critical need for healthcare services to address their personal, emotional, and financial needs to improve their overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unmet needs, anxiety, depression, and quality of life among caregivers of adolescents and young adults with cancer: A cross-sectional study. Cheng, Q., Ng, MSN., Choi, KC., et al.[2022]

A qualitative study involving 36 medically underserved cancer patients identified four key needs for effective patient navigation (PN) programs: improving access to quality care, addressing emotional and practical concerns, considering family issues, and supporting patients throughout their entire cancer journey from diagnosis to long-term survivorship.

Oncology social workers are positioned to play a crucial role in patient navigation, advocating for the inclusion of trained professionals to ensure that the specific needs of underserved cancer patients and their families are met.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social workers as patient navigators for breast cancer survivors: what do African-American medically underserved women think of this idea? Davis, C., Darby, K., Likes, W., et al.[2022]

A patient navigation intervention involving specially trained oncology nurses was offered to 1091 newly diagnosed breast cancer and melanoma patients, with 755 expressing willingness to participate, indicating a strong interest in supportive care.

Approximately 90% of patients who completed the intervention found the patient navigator valuable and accessible, and around 80% reported receiving adequate advice on various supportive care needs, highlighting the intervention's effectiveness in addressing unmet needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a professional patient navigation intervention in a supportive care setting. Berezowska, A., Passchier, E., Bleiker, E.[2021]

A modified Needs Assessment & Service Bridge (NA-SB) tool was developed through collaboration with a 10-member AYA Advisory Board and oncology clinicians to better address the unique supportive care needs of adolescents and young adults with cancer.

The final version of the modified NA-SB includes 58 items that reflect the specific needs of AYA cancer survivors, which may enhance communication between patients and care teams and help prioritize the development of new supportive care resources, potentially improving outcomes for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Midwest Stakeholder Evaluation of an Adolescent and Young Adult Cancer Survivor Needs Assessment Survey. Lee-Miller, C., Montgomery, KE., Evered, J., et al.[2023]

The eSNAP and Caregiver Navigator Intervention was developed to specifically support cancer family caregivers in accessing social support resources, highlighting the need for targeted interventions in cancer care.

Training for caregiver navigators was based on national competencies and adult learning theories, emphasizing the importance of a structured, evidence-based approach to ensure navigators are effective in their roles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training cancer caregiver navigators: experiences from implementing the eSNAP and caregiver navigator intervention. Reblin, M., D'Almeida, H., Barrios-Monroy, V., et al.[2022]

A new support intervention for caregivers of brain tumor patients was developed, utilizing a caregiver navigator to help them access social support and formal services, which is crucial given the unmet needs of these caregivers.

Preliminary data from the first 15 participants indicate high satisfaction and perceived helpfulness of the intervention, suggesting that caregiver navigation could be an effective model for future support programs in neuro-oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing a critical need for caregiver support in neuro-oncology: development of a caregiver navigation intervention using eSNAP social resource visualization. Reblin, M., Wells, KJ., Otto, A., et al.[2022]

There is a significant lack of focused research on the service needs of parent caregivers for adolescents and young adults (AYA) with incurable cancer, as only eight studies were identified that addressed this issue, highlighting a gap in understanding and support.

The scoping review indicates that while healthcare professionals recognize the importance of parental involvement in care, there is insufficient evidence to inform the specific services and support needed for these caregivers, suggesting a critical area for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Service Needs of Parent Caregivers of Adolescents and Young Adults with Incurable Cancer: A Scoping Review. Berger, I., Krishnasamy, M., Thompson, K., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12296515/

Pilot feasibility of a financial and health-related social needs ... This protocol assesses the feasibility of AYA-NAV, a hybrid needs navigation intervention for AYAs with cancer. Findings will inform future randomized studies ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11603903/

Implementation and evaluation of a navigation program for ... Cancer navigation programs aim to support, educate, and empower patients and families, addressing barriers to diagnostics, treatment, ...

3. researchgate.net researchgate.net/publication/393986019_Effectiveness_of_Cancer_Patient_Navigator_Program_to_Reduce_Caregiver_Burden_A_Systematic_Review

(PDF) Effectiveness of Cancer Patient Navigator Program ... The results also showed that patient navigator programs can significantly reduce caregiver burden through improved education, emotional support, ...

4. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21788

Patient navigation across the cancer care continuum: An ... Patient navigation is a strategy for overcoming barriers to reduce disparities and to improve access and outcomes. The aim of this umbrella ...

5. academic.oup.com academic.oup.com/nop/advance-article-abstract/doi/10.1093/nop/npaf048/8124509

CARING intervention for neuro-oncology family caregivers To address the unmet support needs of neuro-oncology family caregivers, our team developed an 8-week intervention, CARING.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11120301/

Need for Behavioral Interventions for Young Adults Living ... This commentary identifies unmet psychosocial needs and offers recommendations for targeted interventions to help improve overall quality of care.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/pon.5937

Financial burden for caregivers of adolescents and young ... Financial navigation interventions have primarily been patient-targeted, with minimal inclusion of the caregiver. Our results suggest a formal ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04960787

NCT04960787 | Financial Navigation Program to Improve ... This clinical trial examines a financial navigation program in helping patients (and their spouses or partner caregivers, if participating) understand and ...

9. medinform.jmir.org medinform.jmir.org/2024/1/e50307

Characteristics of Existing Online Patient Navigation ... Online PNIs have demonstrated excellent potential for improving patient knowledge, transition readiness, self-efficacy, and use of services.