End of LifeIMPACTNCT04330833
Informational Meetings for Planning and Coordinating Treatment
A study testing Novel Communication Intervention in people with End of Life and Communication, run by Indiana University at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- End of Life, Communication, Cancer Metastatic
- What is being tested?
- Novel Communication Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Dec 2020to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 23Show fewer
- 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
- Metastatic desmoplastic small round cell tumor (DSRCT)
- Other metastatic sarcoma/carcinoma-at discretion of attending
- Metastatic unknown primary- or rare pathology- at discretion of attending
- Parent(s) legal decision-maker(s) for child
- Parent(s) ≥18 years of age
- Parent (s) Informed of child's cancer diagnosis
- Parent(s) Able to read, speak and understand English
- Must be willing to be audio recorded during all study sessions.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
MD Anderson Children's Cancer Center
Houston, Texas, 77030
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
Nemours Children's Health
Wilmington, Delaware, 19803
About this study
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.
Read the detailed description
The overall objective of this study is to evaluate the efficacy of a novel communication intervention on quality of life outcomes in children with high-risk cancer. The intervention includes a series of tailored discussions delivered by the child's primary physician/nurse dyad that begins at diagnosis, and integrates visual aids to facilitate conversations with parents about prognosis, hopes, and goals-of-care across the cancer continuum. The central hypothesis is that the intervention will foster alignment of goals of care between providers and parents across the cancer continuum, leading to improved quality of life outcomes. Outcomes include: Enrollment in home hospice care, high-intensity medical interventions, child pain and emotional distress, parental hope, parental uncertainty and distress.
- Conditions
- End of Life, Communication, Cancer Metastatic
- Being tested
- Novel Communication Intervention, Enhanced Usual Care Parent Education
- Keywords
- interventions, pediatric palliative care
- Medical subject headings
- Death, Communication, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Communication InterventionOther
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.
Enhanced Usual Care Parent EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Novel Communication Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
High intensity medical interventions include: code status order to attempt cardiopulmonary resuscitation, intensive care unit admission within the last 30 days, IV chemotherapy within last 14 days, greater than 2 emergency department visits within last 30 days, more than 1 hospitalization within last 30 days, not on hospice, admitted to hospice less than 3 days prior to death, intubation or cardiac resuscitation within last 30 days, and death in an acute care setting.
The difference in the use of high-intensity medical interventions at end of life will be tested between the intervention and enhanced usual care groups with a generalized linear mixed model that accounts for subjects clustering within physician/nurse teams via a random effect.
Measured: Within 30 days of death
Impact of Novel Communication Intervention on quality of life in children with cancer and estimated 5-year survival < 25%
Quality of Life is measured with the Pediatric Quality of Life Inventory- General Module, emotional functioning sub-scale and the Pediatric Quality of Life Cancer Module. Scores range from 0-100, with higher scores indicating better health-related quality of life. Results will be modeled with linear mixed models and compared between the Novel Communication Intervention and Enhanced Usual Care Parent Education groups.
Measured: Enrollment, then every 4 months until death or maximum of 4 years
Impact of the Novel Communication Intervention on parental hope.
The Herth Hope Index score ranges from 12-48, with a higher score corresponding to higher levels of hope. Results from the Herth Hope Index are continuous and will be modeled with linear mixed models and compared between the intervention and enhanced usual care groups.
Measured: 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.
The Parent Experience of Childhood Illness Scale (PECI)-Short Form is used to assess parental adjustment in the primary caregiver of children with chronic illness. It consists of four sub-scales with scores ranging from 0-4. Higher scores indicate poorer coping except for emotional resources, which indicates a higher level of support.
Measured: Enrollment, and then every 4 months until death or maximum of 4 years
Impact of Novel Communication Intervention on parental satisfaction with healthcare
The Peds QL HCS (Satisfaction with Healthcare) survey is 24-item scale that measures parent satisfaction with care received from their child's oncology healthcare providers. Subscales assess parental satisfaction with:
- delivery of care;
- information received on child's diagnosis and treatments;
- inclusion of family;
- technical skills in managing their child's symptoms; and
- attention to their child's emotional needs.
Measured: Enrollment, and then every 4 months until death or maximum of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start8 Dec 2020
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for End of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-site, 2-group, cluster-randomized controlled trial, with clusters randomized by pediatric oncology physician-nurse dyads.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Susan M Perkins, Indiana University
- Investigators
- Susan M Perkins, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330833
- Sponsor's protocol ID
- 1904351083
- Other IDs
- R01CA235632-01A1
- Acronym
- IMPACT
- Status last verified
- May 2026
- First submitted
- 19 Feb 2020
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22012943Martin 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.
PubMed 20458647Landier 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.
PubMed 27385664Horner 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.
PubMed 16635187Foster 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.
PubMed 27139113Sawin 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.
PubMed 30939966Hendricks-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.
PubMed 22658379Hendricks-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.
PubMed 29620556Hendricks-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.
PubMed 29513119Hendricks-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.
PubMed 27920233Hendricks-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.
PubMed 18980914Hendricks-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.
PubMed 25623029
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informational Meetings for Planning and Coordinating Treatment
- ClinicalTrials.gov ID
- NCT04330833
- Acronym / sponsor ID
- IMPACT / 1904351083
- Conditions
- End of Life, Communication, Cancer Metastatic
- Keywords
- interventions, pediatric palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall objective of this study is to evaluate the efficacy of a novel communication intervention on quality of life outcomes in children with high-risk cancer. The intervention includes a series of tailored discussions delivered by the child's primary physician/nurse dyad that begins at diagnosis, and integrates visual aids to facilitate conversations with parents about prognosis, hopes, and goals-of-care across the cancer continuum. The central hypothesis is that the intervention will foster alignment of goals of care between providers and parents across the cancer continuum, leading to improved quality of life outcomes. Outcomes include: Enrollment in home hospice care, high-intensity medical interventions, child pain and emotional distress, parental hope, parental uncertainty and distress.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multi-site, 2-group, cluster-randomized controlled trial, with clusters randomized by pediatric oncology physician-nurse dyads.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care Parent Education | Active comparator | Other: Enhanced Usual Care Parent EducationParent(s) and patients receiving care from clinicians whose practice has been randomized to the enhanced usual care parent education group. |
| Novel Communication Intervention | Experimental | Other: Novel Communication InterventionParent(s) and patients receiving care from clinicians whose practice has been randomized to the novel communication intervention group. |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (23 listed)
- 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:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Communication InterventionThe 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. | Other | Novel Communication Intervention |
| Enhanced Usual Care Parent EducationThe 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. | Other | Enhanced Usual Care Parent Education |
Primary outcome
Impact of Novel Communication Intervention on number of days enrolled in hospice in children with cancer and estimated 5-year survival < 25%
Time frame: Within 12 months of death
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.
5 secondary outcomes
Impact of the Novel Communication Intervention on the number and types of high-intensity medical interventions at end of life in children with cancer.
Time frame: Within 30 days of death
Impact of Novel Communication Intervention on quality of life in children with cancer and estimated 5-year survival < 25%
Time frame: Enrollment, then every 4 months until death or maximum of 4 years
Impact of the Novel Communication Intervention on parental hope.
Time frame: 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.
Time frame: Enrollment, and then every 4 months until death or maximum of 4 years
Impact of Novel Communication Intervention on parental satisfaction with healthcare
Time frame: Enrollment, and then every 4 months until death or maximum of 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 22012943Robb 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.
- Background: PubMed 20458647Martin 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.
- Background: PubMed 27385664Landier 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.
- Background: PubMed 16635187Horner 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.
- Background: PubMed 27139113Foster 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.
- Background: PubMed 30939966Sawin 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.
- Background: PubMed 22658379Hendricks-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.
- Background: PubMed 29620556Hendricks-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.
- Background: PubMed 29513119Hendricks-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.
- Background: PubMed 27920233Hendricks-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.
- Background: PubMed 18980914Hendricks-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.
- Background: PubMed 25623029Hendricks-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.
- National Cancer Institute Resource: Children with cancer: A parents' guide.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan M Perkins, PhD principal investigator
Indiana University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Communication Intervention in people with End of Life and Communication, run by Indiana University at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Novel Communication Intervention on number of days enrolled in hospice in children with cancer and estimated 5-year survival < 25% (time frame: Within 12 months of death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04330833, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.