Informational Meetings for Planning and Coordinating Treatment, The IMPACT Trial

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor Brain Tumor Liver Cancer / Hepatoblastoma Sarcoma Solid Tumor	NCT ID:	NCT04330833
Trial Phases:		Protocol IDs:	IUSCC-0705 (primary) NCI-2021-01462
Eligibility:	1 Months and older, Male and Female	Study Type:	Supportive care
Study Sponsor:	Indiana University/Melvin and Bren Simon Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT04330833

Summary

This clinical trial investigates parental responses about their information needs, emotions, support resources, appraisal of their child’s symptom management, and their child’s emotions and symptom management. Information from this study may help researchers better understand how to assist parents in coordinating cancer treatment.

Objectives

PRIMARY OBJECTIVE:
I. Determine the efficacy of Communication Plan: Early through End of Life (COMPLETE) versus usual care to foster hospice enrollment percentage (%).

SECONDARY OBJECTIVES:
I. Determine the efficacy of COMPLETE on child outcomes: pain and emotional suffering; and use of high intensity medical interventions at end of life (EOL).
II. Determine the efficacy of COMPLETE on parent outcomes: emotional distress, uncertainty and hope, and satisfaction with healthcare.

EXPLORATORY OBJECTIVE:
I. Examine the extent to which the effects of COMPLETE on child and parent outcomes are mediated through therapeutic alliance and goals-of-care alignment.

OUTLINE: Participants are assigned to Arm A or B based on the arm their pediatric oncology practice has been randomized.

ARM A (Enhanced usual care control): Parents participate in educational group sessions with the registered nurse every 1-4 months for up to 3 sessions where parents choose 2-3 topics to review. Parents and children complete questionnaires over 25-40 minutes every 3-4 months for up to 10 times.

ARM B (COMPLETE intervention): Parents participate in educational group sessions with the registered nurse and physician every 1-4 months for up to 3 sessions with the purpose of improving parental comprehension of the options for goals of treatment, along with the benefits and burdens of each option. Parents and children complete questionnaires over 25-40 minutes every 1-4 months for up to 10 times.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.