Informational Meetings for Cancer Care Coordination

(IMPACT Trial)

No longer recruiting at 8 trial locations

Overseen By Susan M Perkins, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Joan E. Haase

Disqualifiers: Neurological impairments, Child no assent, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new communication approach to help parents of children with cancer better align their treatment goals with their healthcare team. The aim is to determine if this improved communication can enhance the quality of life, especially for children facing tough prognoses. The trial will compare two groups: one receiving standard care education (Enhanced Usual Care Parent Education) and the other experiencing this novel communication intervention. Children who have been newly diagnosed or have relapsed cancer, along with parents who are informed about the diagnosis and can speak English, might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative communication strategies that could significantly improve patient and family experiences.

Will I have to stop taking my current medications?

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

What prior data suggests that this communication intervention is safe for use in cancer care coordination?

Studies have shown that coordinating care can enhance patient safety by improving communication among doctors, nurses, and patients. Research indicates that these efforts are generally well-received, as they help everyone understand the treatment goals.

No reports of serious side effects have emerged from this type of communication improvement. Since this trial does not involve testing a new drug or medical device, the safety risks remain very low. The focus is on fostering better conversations and ensuring everyone understands the care plan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance communication between clinicians and families dealing with cancer. Unlike traditional care, which often relies on standard information-sharing practices, the novel communication intervention focuses on improving the way information is exchanged to better support patients and their parents. By personalizing and enhancing communication, this approach has the potential to improve understanding, reduce stress, and ultimately lead to better coordination of cancer care.

What evidence suggests that this trial's communication interventions could be effective for improving cancer care coordination?

This trial will compare two approaches to improving communication in cancer care: Enhanced Usual Care Parent Education and a Novel Communication Intervention. Research has shown that new communication methods can help doctors better understand and incorporate patient preferences into treatment plans. One study found that real-time coaching for doctors improved their ability to grasp what patients value in their care. Additional research suggests that using a mix of communication methods can enhance the quality of conversations between patients and doctors in cancer care. Good communication strengthens relationships between patients and healthcare providers, which is crucial for improving patient outcomes, especially in challenging situations like end-of-life care. These findings support the idea that better communication can positively impact the quality of life for children with cancer and their families. ^{2 4 6 7 8}

Who Is on the Research Team?

Susan M Perkins, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for parents of children (1 month to <18 years) with cancer and a poor prognosis. The child must provide assent if ≥7 years old. It includes various diagnoses like high-grade gliomas and metastatic sarcomas, among others. Parents must be legal decision-makers, informed about the diagnosis, speak English, and agree to audio recordings during study sessions.

Inclusion Criteria

My child was diagnosed or had a relapse of cancer less than 16 weeks ago.

Poor prognosis with estimated overall survival of less than 25% or at the discretion of the attending physician

My child is 7 or older and agrees to participate.

Exclusion Criteria

My parent has brain or thinking problems that may affect their ability to participate in the study.

I do not consent to audio recordings during sessions.

My child, who is 7 or older, has not agreed to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

A novel communication intervention is delivered by trained physician and nurse dyads to parents of children with cancer to foster alignment of the goals of treatment.

Ongoing throughout treatment

Regular visits as per treatment schedule

Follow-up

Participants are monitored for quality of life outcomes and parental satisfaction with healthcare.

Every 4 months until death or maximum of 4 years

Regular assessments every 4 months

End-of-life care

Assessment of high-intensity medical interventions and hospice enrollment at end of life.

Within 30 days of death

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care Parent Education
• Novel Communication Intervention

Trial Overview The trial tests a new communication strategy by physician-nurse teams aimed at aligning treatment goals with parental expectations to potentially improve quality of life for children facing end-of-life situations due to cancer.

How Is the Trial Designed?

Group I: Novel Communication Intervention Experimental Treatment 1 Intervention

Parent(s) and patients receiving care from clinicians whose practice has been randomized to the novel communication intervention group.

Group II: Enhanced Usual Care Parent Education Active Control 1 Intervention

Parent(s) and patients receiving care from clinicians whose practice has been randomized to the enhanced usual care parent education group.

Who Is Running the Clinical Trial?

Joan E. Haase

Lead Sponsor

Trials

1

Recruited

110+

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 368 cancer survivors, having a cancer care coordinator (CCC) significantly improved physical health-related quality of life (HRQoL) for patients with low health literacy, indicating that CCCs can help vulnerable patients navigate healthcare challenges more effectively.

While overall physical HRQoL was not significantly associated with having a CCC for all patients, the positive impact on those with low health literacy suggests that targeted support may enhance recovery and well-being in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships between health literacy, having a cancer care coordinator, and long-term health-related quality of life among cancer survivors. Del Vecchio, NJ., McDowell, BD., Carter, KD., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8147509/

Impact of a Novel Goals-of-Care Communication Skills ... Conclusion: Our real-time communication skills coaching INT resulted in a significant increase in oncologists' ability to elicit patient values during GoC ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6257019/

Cancer care coordination: opportunities for healthcare ... In this commentary, we discuss opportunities to explore issues related to care coordination at three points on the cancer care continuum.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pon.70108

Communication Interventions Targeting Both Patients and ... Results indicate that combined communication interventions in oncology may improve patient-clinician communication outcomes in oncology settings ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO-24-01243

Delivering High-Quality Cancer Care: Charting a New ... In this manuscript, we review the goals and recommendations made in 2013 NASEM report and describe progress made to date despite the challenges noted in the ...

5. cancercontrol.cancer.gov cancercontrol.cancer.gov/sites/default/files/2020-06/pcc_monograph.pdf

Patient-Centered Communication in Cancer Care Table 1.3 Outcomes of Effective Communication. Communication outcomes. • Strong patient/family clinician relationships (trust, rapport, respect, involvement.

6. formative.jmir.org formative.jmir.org/2021/5/e16156

A Novel Digital Patient-Reported Outcome Platform (Noona ... Electronic patient-reported outcome (ePRO) measures increase the safety of cancer treatments and may have an impact on treatment outcome as well ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05323409

Improving Comprehensive Care of Cancer Patients | ... This study evaluates a novel shared care model for cancer survivors with chronic comorbidities, called OPTIMISE (Oncology-Primary Care Partnership to Improve ...

8. nature.com nature.com/articles/s44401-025-00020-9

Care coordination and patient safety outcome: a graph- ... This study highlights how care coordination can be modeled at scale using EHRs and can affect patient care safety outcomes.