Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular T… (NCT06689800) | Clinical Trial Compass
RecruitingNot Applicable
Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy
United States60 participantsStarted 2024-11-26
Plain-language summary
The investigators will conduct a pilot feasibility and efficacy trial of a newly developed family health communication tool (called Let's Get REAL) in increasing youth involvement in real-time stem cell transplant and cellular therapy decisions (SCTCT). The investigators will pilot the intervention among 24 youth and their parents, stratified by youth age (stratum 1, 8-12 years of age and stratum 2, 13-17 years of age).
Who can participate
Age range
8 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 Youth:
* Children or adolescents 8-17 years of age referred for SCTCT.
* Diagnosis of malignant or nonmalignant disorder.
* Referred for any type of SCTCT. Autologous and allogeneic stem cell and cellular therapies are eligible.
* Planning to meet with a provider to discuss SCTCT.
* Must have the ability to understand and willingness to consent to participate after reviewing an IRB approved informed assent document.
* Must speak English and be cognitively able to participate.
Inclusion Criteria Parents:
* Parent or guardian of a child 8-17 years of age with any diagnosis referred for any type of SCTCT. Diagnoses may include malignant and nonmalignant disorders. Autologous and allogeneic stem cell and cellular therapies are eligible. Parent or guardian is defined as an adult who usually cares for the youth and has authority to make medical decisions for them.
* Must have the ability to understand and willingness to consent to participate after reviewing an IRB approved informed consent document.
* Must speak English and be cognitively able to participate.
Exclusion Criteria Youth:
* Active medical problems severe enough to preclude study participation at the time of recruitment.
* Patients who are otherwise eligible, but whose primary transplant physician does not want them to participate in the study.
* Lacks cognitive capacity to complete study activities, as determined by consenting professional.
Exclusion Criteria Parents:
* Their youth referre…
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
Feasibility of intervention as measured by the Feasibility of Intervention questionnaire
Timeframe: Up to 4 weeks after SCTCT consultation (estimated to be week 8)
2
Acceptability of intervention as measured by the Acceptability of Intervention questionnaire
Timeframe: Up to 4 weeks after SCTCT consultation (estimated to be week 8)
3
Appropriateness of intervention as measured by the Intervention of Appropriateness questionnaire
Timeframe: Up to 4 weeks after SCTCT consultation (estimated to be week 8)
4
Feasibility of intervention as measured qualitatively
Timeframe: Up to 8 weeks after SCTCT consultation (estimated to be week 16)
5
Acceptability of intervention as measured qualitatively
Timeframe: Up to 8 weeks after SCTCT consultation (estimated to be week 16)
6
Appropriateness of intervention as measured qualitatively
Timeframe: Up to 8 weeks after SCTCT consultation (estimated to be week 16)