Educational and Informational Intervention for Advanced Cancer Parents

(EC-PC Trial)

No longer recruiting at 6 trial locations

Overseen By Ellen H Zahlis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Hospice, Non-consenting co-parent

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

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates two educational programs designed to help parents with advanced cancer strengthen relationships with their children and boost confidence in discussing their illness. One program involves a booklet and phone support, while the other includes a more in-depth, five-session series with a patient educator. The goal is to reduce anxiety and depression and improve well-being for both parents and their children. Ideal participants are parents with late-stage cancer and a child aged 5 to 17 living at home. As an unphased trial, this study offers a unique opportunity for parents to gain valuable support and resources tailored to their needs.

Do I need to stop my current medications to join the trial?

The trial does not specify whether you need to stop taking your current medications. All therapies are allowed, so you likely can continue your current treatment.

What prior data suggests that these educational programs are safe for parents with advanced cancer?

Previous studies have shown that educational programs like patient navigation are very safe. These programs support cancer patients by providing information and have successfully improved access to care and outcomes without known risks.

Research on the Enhancing Connections Program also shows it is well-tolerated. This program helps parents with cancer communicate better with their children. Studies have shown it can reduce stress and improve well-being, with no reports of harm or negative effects.

Overall, both educational programs and the Enhancing Connections Program are considered safe. They help parents manage the impact of cancer on their family without introducing new health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions because they offer new ways to support parents with advanced cancer in communicating with their children. Unlike standard psychological support, which often focuses on the patient's mental health, these programs specifically target family communication. The Educational Intervention provides parents with carefully curated materials and counselor support to improve conversations about cancer. Meanwhile, the Enhancing Connections Program offers a structured, five-session approach to equip parents with strategies to support their children emotionally. These interventions aim to strengthen family bonds during a challenging time, potentially leading to better emotional outcomes for both parents and children.

What evidence suggests that these educational programs are effective for parents with advanced cancer?

Research shows that educational programs can greatly assist parents with advanced cancer. In this trial, participants in Group II will receive educational materials, including a carefully selected booklet and a scripted phone call from a trained counselor, to help them discuss their cancer with their child. Studies have found that patient navigation programs, part of these educational efforts, reduce caregiver stress by providing better education and emotional support. As a result, parents may feel more confident in managing their illness and talking to their children.

Participants in Group I will receive the Enhancing Connections Program, which also shows promise. This program includes a 5-session bi-weekly intervention with a patient educator, helping parents improve their skills and confidence in discussing cancer with their children, which can strengthen their relationship. Additionally, these programs may lower anxiety and depression, enhancing the well-being and quality of life for both parents and their children. ^{1 2 3 6 7}

Who Is on the Research Team?

Frances M Lewis, RN, MN, PhD, FAAN

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for parents aged 23-68 with advanced, non-curable cancer who have a child between the ages of 5 and 17 living at home at least half the time. Participants must be able to read/write English, not be in hospice care, and have access to a phone. The non-ill co-parent must consent to participate.

Inclusion Criteria

Read and write English as one of their languages of choice

Ability to understand and the willingness to sign a written informed consent document. Read and write English as one of their languages of choice

I am a parent with late-stage cancer that cannot be cured.

Exclusion Criteria

Patient is in hospice at time of enrollment

Non-ill co-parent does not consent to join study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the 5-session EC-PC program bi-weekly or educational materials with a phone call

10 weeks

5 sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Long-term Follow-up

Effects of family environment and symptom burden on treatment outcomes are assessed

Up to 10 months

What Are the Treatments Tested in This Trial?

Interventions

• Control group
• Educational Intervention
• Enhancing Connections Program
• Informational Intervention
• Questionnaire Administration

Trial Overview The study tests two educational programs aimed at improving quality of life and parenting confidence for those with late-stage cancer. It focuses on enhancing parent-child relationships and managing the impact of cancer on children.

How Is the Trial Designed?

Group I: Group I (enhancing connections-palliative care program) Experimental Treatment 2 Interventions

Patients receive the 5-session EC-PC program bi-weekly with a patient educator about ways to help them talk to and support their child.

Group II: Group II (educational material) Active Control 2 Interventions

Patients receive carefully selected educational booklet that discuss ways to talk about their cancer with their child and a scripted phone call from a trained phone counselor on study.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

Parents of children with cancer actively participated in a study to identify risks associated with home oral chemotherapy, revealing high rates of potential errors, particularly due to miscommunication and unsafe handling of medications.

The study proposed innovative risk reduction strategies, including the use of technology to enhance communication and access to information, aimed at improving the safety of home chemotherapy administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multisite parent-centered risk assessment to reduce pediatric oral chemotherapy errors. Walsh, KE., Mazor, KM., Roblin, D., et al.[2022]

A survey of 1243 oncology certified nurses revealed that they frequently counsel patients on lifestyle topics during chemotherapy, such as hydration, infection monitoring, and exercise, despite the lack of standardized evidence-based guidelines.

Nurses' counseling practices are influenced by their institutions and colleagues, indicating a need for expert consensus guidelines to improve and standardize patient education on lifestyle issues during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy education: current practices of oncology nurses counseling patients. Rogers, B., Pesata, B., Lee, JH., et al.[2021]

A qualitative study involving 14 parents of children with cancer and 8 healthcare providers in Malaysia identified three key themes of information needs: interaction with the healthcare system, care for the child at home, and psychosocial support for parents.

Addressing these information needs is crucial for enhancing psychosocial care, as it empowers parents in their caregiving roles and highlights the necessity for tailored informational resources from healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information needs of Malaysian parents of children with cancer: A qualitative study. Tan, CE., Lau, SCD., Latiff, ZA., et al.[2022]

The iFOCUS program, developed as a web-based adaptation of the effective FOCUS program for advanced cancer patients and their caregivers, was found to be acceptable and usable based on feedback from 42 participants, including patient-caregiver dyads.

The development process utilized the agile Scrum methodology, which allowed for iterative improvements and efficient collaboration among diverse teams, highlighting the importance of user involvement in creating effective eHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A self-management psychoeducational eHealth program to support and empower people with advanced cancer and their family caregivers: Development using the scrum methodology. Van Goethem, V., Dierickx, S., Matthys, O., et al.[2023]

A study involving 24 parents of newly diagnosed children with cancer found that the average retention of pediatric oncology home care education was low, with a mean score of 4 out of 6.

Parents with only a high school education and those with limited cancer health literacy had the lowest retention scores, suggesting that future educational interventions should be tailored to address these sociodemographic disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of socioeconomic markers on parents' retention of pediatric oncology home care education: A pilot study. Hentea, C., Downs, SM., Tucker Edmonds, B., et al.[2023]

Individuals with advanced cancer often struggle to find reliable and useful information about their condition, highlighting a significant gap in informational resources.

Effective communication skills among healthcare professionals are crucial for addressing the informational needs of patients and their families, suggesting that improving these skills can enhance nursing practice and patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information and communication needs of individuals living with advanced cancer. Marcusen, C.[2013]

A structured education program for parents of children with cancer was developed and successfully pilot-tested, incorporating medical and psychosocial content to enhance existing support services.

Parents who participated in the program reported increased knowledge retention and emotional benefits, indicating that the diverse teaching methods used were effective and well-received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an education program for parents of children with cancer. Rudolph, LA., Pendergrass, TW., Clarke, J., et al.[2006]

Digital health interventions, such as mobile apps and electronic health records, can enhance patient safety for children and their parents by providing preventive measures and risk management strategies, as identified in a scoping review of 13 studies.

These interventions can improve the continuity of care from hospitalization to home, thereby increasing children's safety and quality of care through better engagement with healthcare providers after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health intervention on patient safety for children and parents: A scoping review. Park, J., Jeon, H., Choi, EK.[2023]

A systematic review of 15 studies highlighted that interventions aimed at engaging patients and their families in safety measures can improve safety perceptions, particularly those focused solely on providing information.

Interventions that combined both information and active involvement showed varied effectiveness, indicating a need for more comprehensive and rigorously designed studies to better understand how to engage patients and families in enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Engage Patients and Families in Patient Safety: A Systematic Review. Lee, M., Lee, NJ., Seo, HJ., et al.[2022]

The implementation of the COG Standardized Education Checklist for families of newly diagnosed children with cancer was feasible, with 81% of checklists completed, indicating that the tool is practical for use in clinical settings.

Feedback from parents and nurses showed that the checklist was well-received, with 92% of nurses finding it useful, suggesting that it effectively supports education for safe at-home care after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing and Evaluating a Standardized New Diagnosis Education Checklist: A Report From the Children's Oncology Group. Duffy, EA., Herriage, T., Ranney, L., et al.[2022]

The Structured Discharge Teaching Intervention (SDTI) significantly improved the process of discharge education for parents of children with cancer, leading to higher nurse involvement and satisfaction, but did not change parent readiness or coping scores after discharge.

Despite the improvements in discharge education, nearly 60% of patients experienced unplanned healthcare encounters within 30 days of discharge, indicating a need for further testing and refinement of the SDTI in various pediatric oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Structured Discharge Education Intervention for Parents of Newly Diagnosed Pediatric Oncology Patients. Landier, W., York, JM., Wadhwa, A., et al.[2023]

This systematic review aims to evaluate the outcomes of patient education for adults taking oral anticancer agents, addressing a gap in the literature regarding safety and efficacy concerns raised by patients.

The review will analyze various factors such as content, methodology, and healthcare professionals involved, which could lead to improved safety and patient satisfaction in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of patient education in adult oncologic patients receiving oral anticancer agents: a systematic review protocol. Fonda, F., Cedrone, S., Sartor, I., et al.[2023]

The My Child's Safety web-based education program significantly improved caregivers' awareness of patient safety for children with cancer, as shown by pre- and post-test results.

After using the program, caregivers felt more empowered to ask questions about procedures and treatments, indicating an increase in their understanding of their rights during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of My Child's Safety Web-Based Program for Caregivers of Children with Cancer in South Korea. Park, BK., Lee, E.[2021]

A survey of 201 Children's Oncology Group institutions revealed that patient and family education is primarily delivered by individual providers, with advanced practice nurses responsible for education in 32% of cases.

The most common mandatory education topic for newly diagnosed pediatric cancer patients was 'fever', and 77% of institutions utilized the 'teach-back' method to ensure understanding, highlighting the importance of effective communication in patient education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Survey of Institutional Patient/Family Educational Practices for Newly Diagnosed Pediatric Oncology Patients. Withycombe, JS., Andam-Mejia, R., Dwyer, A., et al.[2019]

A survey of 199 pediatric oncology nurses identified that the most important educational topic for parents of children with cancer is information about treatment, followed by bone marrow suppression, which nurses spend the most time teaching.

Teaching priorities vary throughout the treatment process, with end-of-life issues and alternative therapies ranked as low in importance, suggesting a need for focused educational programs tailored to different stages of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of pediatric oncology nurses' perceptions of parent educational needs. Kelly, KP., Porock, D.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05701085

Patient Navigator PRE-ACT Educational Intervention to ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11063100/

Patient Navigation in Cancer Treatment: A Systematic Review This systematic review provides compelling evidence supporting the value of patient navigation programs in cancer treatment.

3. 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 ...

4. 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, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11459495/

Impact of Virtual Navigation on the Education and Access ... This study explores a unique role that virtual navigation may play in helping accommodate healthcare for many cancer patients in underserved areas.

6. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08633-5

study protocol for the EU NAVIGATE International Pragmatic ... Cancer navigation programs aim to support, educate, and empower patients and families, addressing barriers to diagnostics, treatment, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6987734/

Enhancing Connections-Palliative Care: A Quasi ... In 2018, an estimated 381,777 children were impacted by a new diagnosis of cancer in a parent, and an estimated 20% of parents were diagnosed with advanced ...