- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07695116
Cancer in the Small Developing Island States of the Eastern Caribbean (CaSIDEC)
Overseas Care and Cancer Survivorship in Small Island Developing States of the Eastern Caribbean
Caribbean studies examining overseas cancer care were lacking patient-level data. Investigators will collect data from patients by establishing a cohort of survivors across six small island developing states (SIDS) (Antigua, Dominica, Grenada, Saint Kitts, Saint Lucia and Saint Vincent). This proposal is novel for the Caribbean, and it is the first step in identifying the critical performance gaps and leverage points in the process of overseas referral for cancer care. Investigators will compare for the first time, the characteristics and experiences of Caribbean cancer survivors in SIDS who seek care overseas to those who received care on-island.
My overarching goal is to investigate the effects of overseas travel for care on patient-centered outcomes in Caribbean SIDS, and to build a research resource to study cancer survival, as I develop my career as an independent mixed-method investigator.
Our primary aims are to (P1): Map patterns of overseas travel for cancer care among cancer survivors of six member states of the OECS and (P2): Explore the lived experience of cancer survivors and caregivers and how overseas travel for care affects their social support systems.
Investigators anticipate that (H1) a substantial proportion of cancer survivors travel outside of their resident country for cancer. We expect certain destinations to be more frequented among cancer survivors by individual characteristics (cancer site, stage and country of residence). We also expect that (H2) overseas care may be associated with both challenges and adaptations in social support systems, as explored qualitatively through survivor and caregiver accounts.
Přehled studie
Detailní popis
CaSIDEC is an acronym for "Cancer in SIDS of the Eastern Caribbean". Our overarching ambition is to explore how overseas travel for care may affect key domains of cancer survivorship. Survivorship will be our long-term focus and goes beyond survival as commonly measured in clinical trials (i.e. time to death from diagnosis) and will include measures on how individuals experience life with cancer. In this study, overseas care will be considered as any travel across international country borders (including the Caribbean) regardless of the payment mechanism (e.g. out of pocket or government subsidized).
As a first step, investigators wish to contribute towards building research capacity in SIDS. The CaSIDEC study aims to generate foundational evidence on transnational cancer care pathways and survivorship in SIDS of the Eastern Caribbean. Given the limited availability of standardized epidemiological data in this region, investigators wish to establish data resources, measurement approaches, and analytic frameworks necessary to support future hypothesis-driven and causal research on this topic.
In terms of impact, the data from the current study will guide decisions at the patient, provider and policy level. It will inform notably decisions on how overseas referral pathways should be organized across the OECS subregion.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
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St John's, Antigua a Barbuda
- Breast Friends Women in Touch
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Roseau, Dominika
- Dominica Cancer Society
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Saint George's, Grenada
- St.George's University
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Castries, Svatá Lucie
- VALIRI
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Basseterre, Svatý Kryštof a Nevis
- Essence of hope breast cancer foundation
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Kingstown, Svatý Vincent a Grenadiny
- SCORCH cancer support foundation
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Primary aim 1 (P1): We will include cancer survivors 18 years of age or older, able to communicate in English or local dialect (without cognitive impairment), with an invasive cancer diagnosis (any cancer site, histology, and year of diagnosis), and having accessed health services in their island of residence (i.e. Antigua, Dominica, Grenada, Saint Kitts, Saint Lucia and Saint Vincent ) due to their cancer. Participation will include written authorization to access each patient's data from medical records in health care institutions and centers
- Primary aim 2 (P2): For the qualitative segment of this proposal, field investigators across the 6 islands will purposefully identify cancer survivors and caregivers of survivors who (1) are receiving or already finished their initial active treatment at the time of the study, (2) received a treatment requiring the intervention of a medical professional (e.g. surgery, chemotherapy, radiotherapy), and (3) are willing to provide written consent for one-on-one interviews and/or focus group discussions.
Exclusion Criteria:
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Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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Informal caregivers
Informal caregivers of cancer survivors diagnosed in the Eastern Caribbean
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Cancer survivors who travel overseas travel for care (observation)
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Destination country for cancer treatment
Časové okno: At inclusion (0 days)
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We will map and characterize patterns of overseas care.We will compute the proportion or cancer survivors who travelledtraveled overseas for diagnosis and treatment among the entire sample.
The proportion of overseas travel will be computed as well by cancer site, OECS country, period of diagnosis, and type of diagnostics and treatment accessed.
Where possible we will characterize overseas travel by region (Caribbean, North America, South America, Europe, and other) and by destination country.
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At inclusion (0 days)
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Social support system
Časové okno: At inclusion (0 days)
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Qualitative interviews for social support will be initiated by an introductory question "describe the support you received during the cancer journey", then guided by questions and prompts "who", "what was the relationship to you? such as a family, friend, neighbours" and "when".
Participants will be encouraged to focus on aspects of the day-to-day logistics and travel arrangements, experience living overseas.
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At inclusion (0 days)
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Aviane Auguste, PhD, Vaughan A. Lewis Institute for Research and Innovation
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 relevantní podmínky MeSH
Další identifikační čísla studie
- A10-M79-24A
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
Informace o lécích a zařízeních, studijní dokumenty
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