Palliative Care Integration in Pediatric Oncology Phase 1 Clinical Trials
Although cure rates continue to rise, one in five children with cancer still die from their disease, so new therapies are urgently needed. Most advances in childhood cancer treatments have originated through clinical trial research and new therapies must be tested in early phase clinical trials. Phase 1 clinical trials are designed to focus mainly on determining whether a drug is safe, and less on how well it cures a disease. These trials may offer patients and families hope when no other options are available to treat their cancer. However, patients in these trials may also experience treatment-related side effects and earlier death. Patients and families enrolled in phase 1 clinical trials often experience increased levels of distress. This distress may result from physical effects of the disease or treatments, or from worry, sadness, or confusion when making difficult decisions related to care or end-of-life.
Pediatric palliative care (PPC) is a field that aims to ease physical, psychological, emotional, and spiritual suffering and may be beneficial to patients and families enrolling in phase 1 clinical trials. Over the past decade, PPC has been shown to improve quality of life, patient and family healthcare understanding and satisfaction, communication, shared-medical decision making, advanced care planning, and healthcare cost savings. Despite evidence showing the benefits of PPC, it is not used consistently in pediatric oncology care, particularly in the setting of early phase clinical trials. Including PPC experts is a proven way to improve access to specialty care for vulnerable populations. In this application, investigators propose a study to test the feasibility, acceptability, and potential impact of including PPC consultation for pediatric cancer patients and their families during their enrollment in phase 1 clinical trials.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
The proposed single-arm pilot study will use a prospective, longitudinal design conducted across three urban, tertiary care hospitals offering pediatric oncology phase 1 clinical trials (Phoenix Children's, St. Jude Children's Research Hospital, and the National Institutes of Health). These centers were chosen for their geographical diversity and variability in infrastructure and PPC resources to allow for generalizability of findings.
Aim 1: To assess the feasibility of integrating PPC consultation during eligibility screening for pediatric oncology patients enrolling in a phase 1 clinical trial.
Measures: Feasibility of the intervention (PPC consultation) will be assessed using the Feasibility of Intervention Measure (FIM), a high quality, 4-item implementation indicator, to be completed by caregivers of pediatric oncology patients (with or without patient, if patient aged ≥12 years) enrolling in phase 1 clinical trials and their respective oncologists. Additional measures will assess recruitment (total patients/caregivers screened, percent of patients/caregivers eligible to participate in the study, percent of patients/caregivers who assent/consent to study participation), and adherence (the proportion of study assessments completed, and the length of time required to complete study assessments).
Hypothesis: Integration of a PPC consultation at eligibility screening for pediatric oncology patients enrolling in a phase 1 clinical trial will be feasible, meeting the following targets: mean FIM score of ≥ 3 (coded 1-5) for > 50% of caregivers and oncology providers; enrollment: ≥ 70% of eligible patients/caregivers will assent/consent; adherence: ≥ 75% of enrolled participants will complete all PPC study assessments as planned. These target estimates are extrapolated from our preliminary work with this patient population.
Aim 2: To evaluate the acceptability of a PPC consultation with oncologists and caregivers of pediatric patients with cancer during phase 1 clinical trial enrollment.
Measures: Acceptability of the intervention, (PPC consultation) will be assessed using the Acceptability of Intervention Measure (AIM), a 4-item tool administered to caregivers of patients enrolled in phase 1 clinical trials (+/- patients if ≥ 12 years) and their respective oncologists. Additional measures will assess attrition (the proportion of enrolled patients lost to follow-up/withdrawal).
Hypothesis: Integration of a PPC consultation at eligibility screening for pediatric oncology patients enrolling in a phase 1 clinical trial will be acceptable, with a mean AIM score of ≥ 3 (coded 1-5) for > 70% of caregivers and oncology providers.
Aim 3: To assess patient/caregiver perceptions of the impact of a PPC consultation on quality of life and facilitators/barriers to PPC consultation integration into the standard of care for pediatric patients with cancer enrolling on phase 1 clinical trials. Methods: Investigators will conduct semi-structured qualitative interviews with caregivers (+/- patients if ≥ 12 years) enrolled in phase 1 clinical trials following the completion of a PPC consult by asking: What was the impact of a PPC consultation at the time of enrollment in a phase 1 clinical trial on the quality of life of the participant? These interviews will also explore barriers and facilitators to PPC consultation at this timepoint. Investigators will thematically analyze the audio-recorded interviews. Investigators will also administer the PROMIS-Pediatric Profile-2510, a validated tool for caregivers, children, and adolescents (≥ 8 years), to assess the potential impact of the intervention on health-related quality of life.
Typ studie
Zápis (Odhadovaný)
Fáze
- Raná fáze 1
Kontakty a umístění
Studijní místa
-
-
Arizona
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Phoenix, Arizona, Spojené státy, 85016
- Nábor
- Phoenix Children's Hospital
-
Kontakt:
- Mikaela Rollins, BS
- Telefonní číslo: 602-933-0715
- E-mail: mrollins@phoenixchildrens.com
-
-
Maryland
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Bethesda, Maryland, Spojené státy, 20814
- Zatím nenabíráme
- National Institutes of Health
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Kontakt:
- Brian Pennarola, MD
- Telefonní číslo: 240-760-7250
- E-mail: Brian.pennarola@nih.gov
-
-
Tennessee
-
Memphis, Tennessee, Spojené státy, 38105
- Zatím nenabíráme
- St. Jude Children's Research Hospital
-
Kontakt:
- Erica Kaye, MD, MPH
- Telefonní číslo: 901-595-8188
- E-mail: erica.kaye@stjude.org
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Patients (aged 0-25 years) diagnosed with cancer and undergoing evaluation for enrollment in a phase 1 trial, their caregivers, as well as their primary treating oncologist are eligible for study participation.
Exclusion Criteria:
- Previous palliative care exposure
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Pediatric Palliative Care Consultation
Formal PPC consultation will be completed by a subspeciality-trained PPC physician at each participating site for all study participants during the eligibility screening period for the phase 1 trial.
Subsequent standard of care PPC follow-up visits will occur every 2-4 weeks to allow for variations in phase 1 trial structure.
|
Formal PPC consultation will be completed by a subspeciality-trained PPC physician at each participating site for all study participants during the eligibility screening period for the phase 1 trial.
Subsequent standard of care PPC follow-up visits will occur every 2-4 weeks to allow for variations in phase 1 trial structure.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Feasibility
Časové okno: 2 years
|
Feasibility will be defined as a mean FIM score of ≥ 3 (coded 1-5) for > 50% of caregivers and oncology providers; enrollment: ≥ 70% of eligible patients/caregivers will assent/consent; adherence: ≥ 75% of enrolled participants will complete all PPC study assessments as planned.
Themes identified from qualitative findings, specifically from caregivers/patients' experiences with the PC team (either positive or negative) will be compared alongside quantitative data in a matrix to assess for overlap or variances in findings related to intervention feasibility, acceptability, and impact.
|
2 years
|
|
Acceptability
Časové okno: two years
|
Acceptability will be defined as a mean AIM score of ≥ 3 (coded 1-5) for > 70% of caregivers and oncology providers.
Themes identified from qualitative findings, specifically from caregivers/patients' experiences with the PC team (either positive or negative) will be compared alongside quantitative data in a matrix to assess for overlap or variances in findings related to intervention feasibility, acceptability, and impact.
|
two years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Barriers and Facilitators to Palliative Care Integration
Časové okno: two years
|
To assess participants' perceptions of how PPC integration at the time of phase 1 trial enrollment impacted quality of life and facilitators/barriers to PPC consultation, investigators will conduct a one-time, semi-structured interview with the caregiver/patient (> 12 years) within 1 week following the third PPC visit or phase 1 study completion.
|
two years
|
|
Impact on quality of life
Časové okno: two years
|
Investigators will administer the PROMIS-Pediatric Profile-25 survey (Patient-Reported Outcomes Measurement Information System) at baseline and within 1 week following the third PPC visit or phase 1 study completion. Patients' reported outcomes in the context of the PPC intervention will be assessed, including mobility, anxiety, depression, fatigue, peer relationships, and pain interference/intensity. This tool was validated for adolescents aged ≥ 8 years, translated into several languages for non-English-speaking participants, and requires 5-10 minutes for completion. PROMIS results are always reported on a T-score metric, which compares participants' results to a reference population (usually the U.S. general population). The greater the score, the more severe the symptoms (i.e. Less than 55: Normal or better-than-average; 55 - 60: Mild symptoms; 60 - 70: Moderate symptoms; Greater than 70: Severe symptoms). |
two years
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 26-101
- U54AG093230 (Grant/smlouva NIH USA)
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