Trial Title:
Palliative Care and Oncology Survey on Terminology
NCT ID:
NCT05871996
Condition:
Cancer
Conditions: Keywords:
Cancer Survivors
Palliative Care
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
Palliative Care and Oncology Survey on Terminology (POST)
Description:
Each group receives a survey to complete. The only difference between the two is the
inclusion criteria; the surveys are the same.
Arm group label:
Group 1
Arm group label:
Group 2
Summary:
The term '"cancer survivors" is widely used but has different definitions. One definition
describes "cancer survivors" as individuals from the time of diagnosis throughout their
lives, which includes people living with cancer and people free of cancer. The views of
some groups included in this definition of "cancer survivors" have rarely been assessed,
including those with cancer on anticancer treatment and those known to palliative care.
How they view these terms could have important implications for how they receive care
services.
This is an international multi-centre observational study. It aims to recruit 3830
patients internationally across Australia, Canada, Ireland, the United Kingdom, and the
United States of America. Participants known to cancer and/or palliative care hospital or
hospice services as inpatients, outpatients or community patients will be asked to
complete a survey during a one-off visit which should last under 30 minutes. The survey
asks a series of questions to determine the perceptions of patients know to cancer and
palliative care services about the terminologies used to describe them.
Detailed description:
Despite widespread use of the term "cancer survivor", its meaning is not standardised or
universally understood. The most widely used definition incorporates individuals from the
time of diagnosis throughout their lives, which includes people living with cancer and
people free of cancer. The National Cancer Institute (NCI) (2022) subscribes to this
description, and divides survivorship into three phases: individuals with early-stage
cancer where the goal is curative intent, individuals with advanced or metastatic cancer
where the goal is to prolong life, and individuals with end-stage cancer where the goal
is end-of-life care. It presents these as a continuum. It has been suggested that the
term, "cancer survivor," is not designed to be a label, but rather to describe a
population of people who have a history of cancer (NCI, 2022), recognising that the
heterogeneous group encompassed by this term may not all subscribe to it. The perception
of patients towards "cancer survivor" in their context has been sought for a variety of
groups, generally including patients without progressive disease who have completed
treatment, or those undergoing treatment. These individuals have various attitudes
towards their inclusion in the term, with some considering it inappropriate, and others
finding the group too diverse to be acceptable. One group may be patients known to
palliative care services. Palliative care aims to provide holistic care for individuals
with health-related suffering due to severe illness to improve the quality of life of
patients, their families and caregivers, particularly at the end of life. These patients
also fit the definition of 'cancer survivors' using the NCI's definition. There is a
particular paucity of evidence on their opinion on survivorship terminology, which may
have important implications for patients' receipt of care and the adoption and
understanding of this terminology within palliative care services.
The aim of this study is to determine the perceptions of heterogeneous groups of patients
known to oncology and palliative care services regarding the terminologies used to
describe them, and in particular the term "cancer survivor." This is an international,
multicentre, observational study. The study will seek participants known to oncology and
palliative care services in 2 target groups in Australia, Canada, Ireland, the United
Kingdom (UK), and the United States of America (USA). The overall lead investigator of
the study will be based in Our Lady's Hospice & Care Services, Dublin, Ireland. Each
country will have a national site lead who will obtain ethical approval and manage
patient recruitment within their country. The overall Principal Investigator (PI) and his
research team will lead recruitment in Ireland and overall governance for the study.
Established researchers will be identified to lead the project in Australia, Canada, the
UK and the USA. They will be required to identify local sites, obtain local ethical /
research approval, and provide local support to the overall PI and research team. The
study will recruit 383 individuals in Groups 1 and 2 in each area i.e., 1915 individuals
for each Group, and 3830 individuals overall.
The study involves a single assessment, which should take 15-30 minutes (and involves
completion of a study-specific English-language questionnaire). Case Record Forms (CRFs)
will be amended for each country relating to local specifications for education and
ethnicity. There will be 2 sections - a researcher section and a participant section,
consisting of 3 parts, to complete. Data will be recorded on paper CRFs and transferred
onto a secure online platform.
The study will conform to the General Data Protection Regulations (GDPR) (2018) and
equivalent legislation in the different countries. All data will be treated as
confidential, and data will be pseudonymised to protect the participants' identities.
Descriptive statistics will be used to describe individual country data. Quantitative
data analysis will be carried out using SPSS software and appropriate statistical tests.
The study will be conducted in accordance with the Declaration of Helsinki, and the
International Conference on Harmonisation guidance on Good Clinical Practice.
Investigators are responsible for ensuring that appropriate ethical (and other necessary)
approvals are in place before the study commences at their study site. The study is
considered low risk, and not burdensome for participants.
Criteria for eligibility:
Study pop:
Patients known to hospice inpatient units, community palliative care services, hospital
palliative care teams and/or oncology services at specified hospices and cancer centres
internationally will be invited to participate. Participants may be inpatients,
outpatients or community patients associated with the study sites. Participants must meet
all of the inclusion criteria for the study, and none of the exclusion criteria for the
study. Convenience sampling will be undertaken. Potential participants will be identified
by the clinical team. The clinical team will ask them if they would be interested in
taking part in a study. If they agree, the research team will arrange to meet with the
patient.
Sampling method:
Non-Probability Sample
Criteria:
Group 1: Individuals with a diagnosis of cancer known to palliative care services
Inclusion criteria:
- Diagnosis of cancer
- Under the care of palliative care services as an inpatient, outpatient or community
patient
- Age ≥18 years
- Able to speak / read English (enough to complete questionnaire)
Exclusion criteria:
- Unable to provide consent
- Unable to complete questionnaire
Group 2: Individuals with a diagnosis of cancer receiving anti-cancer treatment known to
oncology services
Inclusion criteria:
- Diagnosis of cancer
- Under the care of oncology services and currently receiving an anticancer treatment
regimen of any kind
- Age ≥18 years
- Able to speak / read English (enough to complete questionnaire)
Exclusion criteria:
- Unable to provide consent
- Unable to complete questionnaire
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St Vincent's University Hospital
Address:
City:
Dublin
Zip:
D04 T6F4
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Amy Taylor, MBChB
Phone:
+35314986243
Phone ext:
6243
Email:
ataylor@olh.ie
Facility:
Name:
Our Lady's Hospice & Care Services
Address:
City:
Dublin
Zip:
D6W RY72
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Amy GS Taylor, MBChB
Phone:
4986243
Phone ext:
0035301
Email:
ataylor@olh.ie
Facility:
Name:
Royal Surrey County Hospital
Address:
City:
Guildford
Zip:
GU2 7XX
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Charlotte Leach
Email:
charlotte.leach@nhs.net
Start date:
October 3, 2023
Completion date:
October 2024
Lead sponsor:
Agency:
Our Lady's Hospice and Care Services
Agency class:
Other
Collaborator:
Agency:
Royal Surrey County Hospital NHS Foundation Trust
Agency class:
Other
Source:
Our Lady's Hospice and Care Services
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05871996
http://cancercontrol.cancer.gov/ocs/definitions
