# Evaluation of the Communication Plan Early through End-of-Life (COMPLETE) Intervention

> **NIH NIH R01** · INDIANA UNIVERSITY INDIANAPOLIS · 2020 · $673,861

## Abstract

The majority of children with cancer (>60%) experience pain and emotional suffering at end of life (EOL) and
their parents experience distress. These children are not enrolled in hospice and have high rates of futile, high-
intensity medical interventions (e.g., ICU admission) at EOL. In contrast, most parents would prefer a home
death for their child. There is strong evidence in adults with cancer that hospice enrollment results in less pain
and emotional suffering, fewer high-intensity medical interventions, and reduced caregiver distress. In adults,
early EOL discussions facilitate longer hospice enrollment which is associated with better ratings of EOL care
and is congruent with patient preferences. Early EOL discussions with parents of children with cancer fosters
hope and emotional support and reduces uncertainty. However, no evidence-based interventions exist that
foster early hospice enrollment or reduce the pain and emotional suffering in children with terminal cancer. The
long-term goal is to identify effective interventions to improve child QOL at EOL and lessen parents’ distress.
The overall objective of this application is to evaluate the efficacy of COMPLETE (Communication Plan: Early
through End of Life), a series of tailored discussions delivered by the child’s primary MD/RN dyad, that begin at
diagnosis, and integrates visual aids, to empathically facilitate conversations with parents about prognosis,
hopes, and goals-of-care across the cancer continuum. The central hypothesis is that COMPLETE will foster
alignment of goals of care between providers and parents when cure is unrealistic, leading to earlier hospice
enrollment, reduced use of high-intensity medical interventions, and less pain and emotional suffering in
children at EOL and less distress in parents. The hypotheses are based on the applicants’ pilot studies
(NIHR21; NR011071-02): COMPLETE resulted in increased hospice enrollment (83% enrolled > 30 days vs
40% nationally), and lower use of high-intensity medical interventions (17% vs 60% nationally). Compared to
baseline, children had significantly less pain and emotional suffering, and parents had significantly lower
distress and uncertainty and more hope. The project rationale is that, if COMPLETE is efficacious, it can be
rapidly translated into clinical practice to support earlier hospice enrollment and improve outcomes of children
with cancer and their parents at EOL. In this multisite cluster-randomized controlled trial of children with cancer
prognosis of < 25% survival and their parents, we aim to determine the efficacy of COMPLETE vs. Attention
control to: 1. Foster earlier hospice enrollment (Primary Aim); 2. Decrease high- intensity medical interventions,
decrease pain and emotional suffering in children at EOL; and, 3. Reduce parental distress and uncertainty
and improve hope. The study innovations include using the oncology MD/RN team to engage parents from
diagnosis and ongoing conversations using visual ...

## Key facts

- **NIH application ID:** 9994856
- **Project number:** 5R01CA235632-02
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Verna L. Ferguson
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $673,861
- **Award type:** 5
- **Project period:** 2019-08-13 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9994856

## Citation

> US National Institutes of Health, RePORTER application 9994856, Evaluation of the Communication Plan Early through End-of-Life (COMPLETE) Intervention (5R01CA235632-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9994856. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*