- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Lokalizacje studiów
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St John's, Antigua i 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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Basseterre, Saint Kitts i Nevis
- Essence of hope breast cancer foundation
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Kingstown, Saint Vincent i Grenadyny
- SCORCH cancer support foundation
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Castries, Święta Lucia
- VALIRI
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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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Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Destination country for cancer treatment
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Śledczy
- Główny śledczy: Aviane Auguste, PhD, Vaughan A. Lewis Institute for Research and Innovation
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- A10-M79-24A
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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