Informational Meetings for Cancer Care Coordination

(IMPACT Trial)

Recruiting at 7 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

110 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Enhanced Usual Care Parent Education, Novel Communication Intervention for cancer care coordination?

Research shows that care coordination, which involves organizing patient care activities and sharing information among all participants concerned with a patient's care, can improve health management and quality of life for cancer patients. Studies highlight the benefits of communication tools and having a cancer care coordinator in enhancing care coordination and patient outcomes. ^{1 2 3 4 5}

How is the Novel Communication Intervention treatment different from other cancer care coordination treatments?

The Novel Communication Intervention is unique because it focuses on improving communication and coordination among healthcare providers and patients, potentially using innovative methods like online forums and multidisciplinary team meetings to enhance care coordination and patient engagement, unlike traditional treatments that may not emphasize these aspects. ^{2 6 7 8 9}

What is the purpose of this trial?

This prospective cluster-randomized trial examines the efficacy of a novel communication intervention delivered by trained physician and nurse dyads to parents of children with cancer within the clinicians' practice, to foster alignment of the goals of treatment. The investigators hypothesize that goal alignment will improve quality of life outcomes, in particular for those patients who reach end of life. Findings from the proposed research will provide essential information to promote communication practice standards that can be rapidly translated into practice to improve outcomes for children, particularly those who reach end of life, and parents.

Research Team

Susan M Perkins, PhD

Principal Investigator

Indiana University

Eligibility Criteria

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.

My child is 7 or older and agrees to participate.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Perceptions of care coordination in a population-based sample of diverse breast cancer patients. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Using social media to assess care coordination goals and plans for leukemia patients and survivors. [2018]

3. Germany 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. [2022]

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

The Challenge of Improving Breast Cancer Care Coordination in Safety-net Hospitals: Barriers, Facilitators, and Opportunities. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Implementation of a Web-Based Communication System for Primary Care Providers and Cancer Specialists. [2023]

6. Scotland pubmed.ncbi.nlm.nih.gov

Communication in and clinician satisfaction with multidisciplinary team meetings in neuro-oncology. [2010]

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

Physician and Practice Characteristics Influencing Tumor Board Attendance: Results From the Provider Survey of the Los Angeles Women's Health Study. [2021]

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

An Internet-Based Collaborative Cancer Conference for Rectal Cancer Influenced Surgeon Treatment Recommendations. [2015]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Care Coordination for Breast Cancer Survivors in Urban Underserved Communities: Will Treatment Summaries and Survivorship Care Plans Be Enough? [2021]