Informational Meetings for Planning and Coordinating Treatment

NCT04330833 | Completed DMC

• 2 other identifiers: 1904351083R01CA235632-01A1
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

End of Life; Communication; Cancer Metastatic

Keywords

interventions; pediatric palliative care

Outcome Measures

Primary Outcomes (1)

• Impact of Novel Communication Intervention on number of days enrolled in hospice in children with cancer and estimated 5-year survival < 25%

  We will compare days enrolled in hospice between the Novel Communication Intervention vs Enhanced Usual Care Parent Education groups using a Wilcoxon Rank Sum Test for clustered data.

  Within 12 months of death

Secondary Outcomes (5)

• Impact of the Novel Communication Intervention on the number and types of high-intensity medical interventions at end of life in children with cancer.

  Within 30 days of death

• Impact of Novel Communication Intervention on quality of life in children with cancer and estimated 5-year survival < 25%

  Enrollment, then every 4 months until death or maximum of 4 years

• Impact of the Novel Communication Intervention on parental hope.

  Enrollment, and then every 4 months until death or maximum of 4 years

• Impact of Novel Communication Intervention on parental adjustment to caring for a child with cancer.

  Enrollment, and then every 4 months until death or maximum of 4 years

• Impact of Novel Communication Intervention on parental satisfaction with healthcare

  Enrollment, and then every 4 months until death or maximum of 4 years

Study Arms (2)

Enhanced Usual Care Parent Education

ACTIVE COMPARATOR

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

Other: Enhanced Usual Care Parent Education

Novel Communication Intervention

EXPERIMENTAL

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

Other: Novel Communication Intervention

Interventions

Novel Communication Intervention OTHER

The intervention is a series of 3 guided discussions (using visual aids) between the child's primary oncology physician/nurse team and the child's parent(s) with the purpose of improving parental comprehension of the options for goals of treatment, along with the benefits and burdens of each option.

Novel Communication Intervention

Enhanced Usual Care Parent Education OTHER

The Enhanced Usual Care Parent Education is a series of 3 discussions between the child's primary oncology nurse and the child's parent(s) designed to control for time and attention. These discussions are focused on answering parents' questions and reviewing routine disease and treatment related information. Parents will receive a 1-hour face-to-face session every 3-4 months for a total of 3 sessions. At each session, parents choose 2-3 topics to review with the nurse.

Enhanced Usual Care Parent Education

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child 1 month to \< 18 years
• Child newly diagnosed, i.e., within 16 weeks (112 days) from time of diagnosis of cancer not including the day of diagnosis, OR
• Child with relapsed cancer, defined as within 16 weeks (112 days) of first-time relapse/evidence of progression of disease as noted by scan or biopsy after previous diagnosis of cancer.
• Child provide assent if age ≥ 7 years
• Poor prognosis, i.e., approximate \< 25 % estimated overall survival or at the discretion of the attending AND/OR:
• Falls into one of the following diagnosis categories, including but not limited to:
• Atypical teratoid rhabdoid tumor
• Glioblastoma multiforme
• Diffuse intrinsic brainstem glioma
• Embryonal tumors with multilayered rosettes
• Other high-grade glioma
• Gliomatosis cerebri
• Metastatic osteosarcoma
• Metastatic Ewing sarcoma
• Metastatic rhabdomyosarcoma

You may not qualify if:

• The parent has neurological/cognitive impairments likely to interfere with study participation;
• The child ≥ 7 years of age does not provide assent
• Parent refuses to be audio recorded during sessions.

Sponsors & Collaborators

• Indiana University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Nemours Children's Health

Wilmington, Delaware, 19803, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

Location

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

MD Anderson Children's Cancer Center

Houston, Texas, 77030, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (12)

• Robb SL, Burns DS, Docherty SL, Haase JE. Ensuring treatment fidelity in a multi-site behavioral intervention study: implementing NIH Behavior Change Consortium recommendations in the SMART trial. Psychooncology. 2011 Nov;20(11):1193-201. doi: 10.1002/pon.1845.

  PMID: 22012943 BACKGROUND

• Martin JS, Ummenhofer W, Manser T, Spirig R. Interprofessional collaboration among nurses and physicians: making a difference in patient outcome. Swiss Med Wkly. 2010 Sep 1;140:w13062. doi: 10.4414/smw.2010.13062. eCollection 2010.

  PMID: 20458647 BACKGROUND

• Landier W, Ahern J, Barakat LP, Bhatia S, Bingen KM, Bondurant PG, Cohn SL, Dobrozsi SK, Haugen M, Herring RA, Hooke MC, Martin M, Murphy K, Newman AR, Rodgers CC, Ruccione KS, Sullivan J, Weiss M, Withycombe J, Yasui L, Hockenberry M. Patient/Family Education for Newly Diagnosed Pediatric Oncology Patients. J Pediatr Oncol Nurs. 2016 Nov/Dec;33(6):422-431. doi: 10.1177/1043454216655983. Epub 2016 Jul 9.

  PMID: 27385664 BACKGROUND

• Horner S, Rew L, Torres R. Enhancing intervention fidelity: a means of strengthening study impact. J Spec Pediatr Nurs. 2006 Apr;11(2):80-9. doi: 10.1111/j.1744-6155.2006.00050.x.

  PMID: 16635187 BACKGROUND

• Foster Akard T, Gerhardt CA, Hendricks-Ferguson V, Given B, Friedman DL, Hinds PS, Gilmer MJ. Facebook Advertising To Recruit Pediatric Populations. J Palliat Med. 2016 Jul;19(7):692-3. doi: 10.1089/jpm.2016.0128. Epub 2016 May 3. No abstract available.

  PMID: 27139113 BACKGROUND

• Sawin KJ, Montgomery KE, Dupree CY, Haase JE, Phillips CR, Hendricks-Ferguson VL. Oncology Nurse Managers' Perceptions of Palliative Care and End-of-Life Communication. J Pediatr Oncol Nurs. 2019 May/Jun;36(3):178-190. doi: 10.1177/1043454219835448. Epub 2019 Apr 3.

  PMID: 30939966 BACKGROUND

• Hendricks-Ferguson VL, Cherven BO, Burns DS, Docherty SL, Phillips-Salimi CR, Roll L, Stegenga KA, Donovan Stickler M, Haase JE. Recruitment strategies and rates of a multi-site behavioral intervention for adolescents and young adults with cancer. J Pediatr Health Care. 2013 Nov-Dec;27(6):434-42. doi: 10.1016/j.pedhc.2012.04.010. Epub 2012 Jun 2.

  PMID: 22658379 BACKGROUND

• Hendricks-Ferguson VL, Haase JE. Parent Perspectives of Receiving Early Information About Palliative and End-of-Life Care Options From Their Child's Pediatric Providers. Cancer Nurs. 2019 Jul/Aug;42(4):E22-E30. doi: 10.1097/NCC.0000000000000589.

  PMID: 29620556 BACKGROUND

• Hendricks-Ferguson VL, Ruebling I, Sargeant DM, Kienstra K, Eliot KA, Howell TG, Sebelski CA, Moore KS, Armstrong K. Undergraduate students' perspectives of healthcare professionals' use of shared decision-making skills. J Interprof Care. 2018 Jul;32(4):481-489. doi: 10.1080/13561820.2018.1443912. Epub 2018 Mar 7.

  PMID: 29513119 BACKGROUND

• Hendricks-Ferguson VL, Pradhan K, Shih CS, Gauvain KM, Kane JR, Liu J, Haase JE. Pilot Evaluation of a Palliative and End-of-Life Communication Intervention for Parents of Children With a Brain Tumor. J Pediatr Oncol Nurs. 2017 May/Jun;34(3):203-213. doi: 10.1177/1043454216676836.

  PMID: 27920233 BACKGROUND

• Hendricks-Ferguson V. Physical symptoms of children receiving pediatric hospice care at home during the last week of life. Oncol Nurs Forum. 2008 Nov;35(6):E108-15. doi: 10.1188/08.onf.e108-e115.

  PMID: 18980914 BACKGROUND

• Hendricks-Ferguson VL, Kane JR, Pradhan KR, Shih CS, Gauvain KM, Baker JN, Haase JE. Evaluation of Physician and Nurse Dyad Training Procedures to Deliver a Palliative and End-of-Life Communication Intervention to Parents of Children with a Brain Tumor. J Pediatr Oncol Nurs. 2015 Sep-Oct;32(5):337-47. doi: 10.1177/1043454214563410. Epub 2015 Jan 26.

  PMID: 25623029 BACKGROUND

Related Links

• National Cancer Institute Resource: Children with cancer: A parents' guide.

MeSH Terms

Conditions

Death; Communication; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Neoplastic Processes; Neoplasms

Study Officials

• Susan M Perkins, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A trained blinded evaluator will meet with participants to complete baseline and subsequent follow-up measures, including end-of-study chart review data. Physician-nurse dyads for each arm are trained differently and naive to alternate study arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biostatistics and Health Data Science

Model Details: This is a multi-site, 2-group, cluster-randomized controlled trial, with clusters randomized by pediatric oncology physician-nurse dyads.

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: April 2, 2020
• Study Start: December 8, 2020
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)