Informational Meetings for Planning and Coordinating Treatment (NCT04330833) | Clinical Trial Compass
CompletedNot Applicable
Informational Meetings for Planning and Coordinating Treatment
United States111 participantsStarted 2020-12-08
Plain-language 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.
Who can participate
Age range
1 Month – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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.
Exclusion Criteria:
* The parent has neurological/cognitive impairments likely to interfere with study participation;
* The child ≥ 7 years of…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Impact of Novel Communication Intervention on number of days enrolled in hospice in children with cancer and estimated 5-year survival < 25%