Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001275550p
Ethics application status
Submitted, not yet approved
Date submitted
12/09/2024
Date registered
18/10/2024
Date last updated
18/10/2024
Date data sharing statement initially provided
18/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Survey of Patient Engagement and Attitudes towards Key research
priorities in Lung cancer - korero tahi
Scientific title
Survey of Patient Engagement and Attitudes towards Key research
priorities in Lung cancer - korero tahi
Secondary ID [1] 312951 0
none
Universal Trial Number (UTN)
Trial acronym
SPEAK - Lung
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 335124 0
Condition category
Condition code
Cancer 331623 331623 0 0
Lung - Non small cell
Cancer 331624 331624 0 0
Lung - Small cell

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patient Questionnaire This is a single arm observational study.

Participants attending an in-person medical assessment will be provided a Patient Information Sheet (PIS) when the check in with the receptionist. The PIS will be provided in the format of a printed leaflet which with information about participation in the study and a range of contact details to reach study investigators with questions and to access cultural support if required. The patient will retain the PIS for their own records. An investigator will be in attendance at all clinics to provide assistance to participants and answer questions.

Patients who indicate they wish to participate will be offered the survey in an electronic format on tablet computer. Where the survey is completed electronically, the consent form will also be completed electronically on the same device. Electronic consent will be stored securely as a .pdf document which will be archived and stored securely, separate to the results of the survey, in accordance with the data management plan. A paper consent form and survey, with identical text and content, will also be available and can be offered to any patients who are not able to complete the electronic version. Investigators will preferentially offer the electronic edition whenever possible in order to increase the efficiency and accuracy of data collection. In this survey, the PIS will be provided separately from the consent form, in order that the patient can retain patient information and contact details, whilst allowing for consent to be incorporated into the electronic survey.

The questionnaire contains a total of 8 questions, covering four topics. We anticipate the survey can be completed in 5-10minutes. It is designed to be completed by the participant themselves, or with assistance from whanau (family). We anticipate the PIC and questionnaire can be completed whilst in the clinic waiting room, without any impact on standard clinical care. Questions include responses recorded on a Likert scale. Questions which include the option for free text answers will be reviewed by the investigators in order to inform the content and design of future studies but will not be formally assessed with qualitative analysis.

The title of the study utilises the Te Reo Maori words 'korero tahi', which can be translated as 'taking together'. Te Reo Maori is an official language of Aotearoa/New Zealand, the jurisdiction in which the study will take place. Inclusion of the maori population is a priority for the investigators of this study. We have intentionally utilised Maori language in title of this study to forward the goal of inclusion and participation.
Intervention code [1] 329482 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339354 0
Ethnicity
1) Proportion of participants with self-identified ethnicity accurately recorded in existing records on the Regional Clinical Portal that is visible to the treating clinician.
Timepoint [1] 339354 0
Analysis after completion of data collection
Secondary outcome [1] 440313 0
Biobanking: Concern regarding privacy and data security if tissue samples were used for biobanking
Timepoint [1] 440313 0
Analysis after completion of data collection
Secondary outcome [2] 440314 0
Biobanking: Patient concern in regard to being informed of study results if tissue samples were used for biobanking
Timepoint [2] 440314 0
Analysis after completion of data collection
Secondary outcome [3] 440315 0
Biobanking: Patient concern regarding care and disposal of tissue if tissue samples were used for biobanking
Timepoint [3] 440315 0
Analysis after completion of data collection
Secondary outcome [4] 440316 0
Biobanking: Concern regarding cultural issues if tissue samples were used for biobanking
Timepoint [4] 440316 0
Analysis after completion of data collection
Secondary outcome [5] 440317 0
Biobanking: Patient concern regarding religious or faith based issues if tissue samples were used for biobanking
Timepoint [5] 440317 0
Analysis after completion of data collection
Secondary outcome [6] 440319 0
Clinical Database: Patient concern in regard to understand how data will be used if confidential health information was entered into a database
Timepoint [6] 440319 0
Analysis after completion of data collection
Secondary outcome [7] 440320 0
Clinical Database: Patient concern regarding the ability to opt out if confidential health information was entered into a database
Timepoint [7] 440320 0
Analysis after completion of data collection
Secondary outcome [8] 440321 0
Clinical Database: Patient concern regarding privacy and data security if confidential health information was entered into a database
Timepoint [8] 440321 0
Analysis after completion of data collection
Secondary outcome [9] 440322 0
Clinical Database: Patient concern access to data by other ground if confidential health information was entered into a database
Timepoint [9] 440322 0
Analysis after completion of data collection
Secondary outcome [10] 440324 0
Clinical Database: Acceptability of a clinical database designed for automatic enrolment without individual signed consent
Timepoint [10] 440324 0
Analysis after completion of data collection
Secondary outcome [11] 440326 0
Place of treatment: Patient preference to receive treatment in a tertiary public hospital
Timepoint [11] 440326 0
Analysis after completion of data collection
Secondary outcome [12] 440328 0
Place of treatment: Patient preference to receive treatment in their closest local hospital
Timepoint [12] 440328 0
Analysis after completion of data collection
Secondary outcome [13] 440329 0
Place of treatment: Patient preference to receive treatment in a local health center or GP Practice
Timepoint [13] 440329 0
Analysis after completion of data collection
Secondary outcome [14] 440331 0
Place of treatment: Patient preference to receive treatment in a community setting
Timepoint [14] 440331 0
Analysis after completion of data collection
Secondary outcome [15] 440333 0
Place of treatment: Patient preference to receive treatment in their own home
Timepoint [15] 440333 0
Analysis after completion of data collection

Eligibility
Key inclusion criteria
Patients attending an in-person Medical Oncology outpatient appointment in thoracic tumour
stream clinic with a diagnosis of Lung Cancer in the Auckland region of New Zealand
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinic attendee with Non-lung cancer diagnosis (eg. Mesothelioma and Thymoma)

2. Patients not attending clinic in-person, eg telephone or videoconference appointments

3. Unable to provide informed consent

4. Unable to participate due to poor performance status or medical instability

5. Children aged under 16 are not within the scope of this survey

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We estimate our current patient cohort to be around 500. The study specific questionnaire will be offered to all patients under the care of the Auckland Medical Oncology thoracic tumor streamed clinic, during the period of recruitment who meet the eligibility criteria. The design of the study aims to characterise the whole patient cohort.

1. Outcome 1 will generate a percentage breakdown of participants by self-identified ethnicity, and the percentage of records correctly documented in electronic medical records

2. Outcome 2 will report the percentage of patients who indicate willingness to participate in biobanking and will report the portion of participants who indicate concern to anticipated
domains on a Likert scale. Free text responses will be reviewed by investigators to guide future studies, but will not be subjected to formal qualitative analysis

3. Outcome 3 will report the percentage of patients who indicate that automatic enrolment in a database without individual consent and will report the portion of participants who indicate concern to anticipated domains on a Likert scale. Free text responses will be reviewed by investigators to guide future studies, but will not be subjected to formal qualitative analysis

4. Outcome 4 will report first preference responses for each of the possible settings for
treatment, this will be broken down by ethnicity and distance from hospital. We do not anticipate adequate numbers of participants in the study period to allow regression
analysis by ethnicity but will produce descriptive analysis to generate hypotheses for further investigation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/10/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 26557 0
New Zealand
State/province [1] 26557 0
Auckland

Funding & Sponsors
Funding source category [1] 317384 0
Charities/Societies/Foundations
Name [1] 317384 0
Maurice Wilkins Center
Country [1] 317384 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 319674 0
None
Name [1] 319674 0
Address [1] 319674 0
Country [1] 319674 0
Other collaborator category [1] 283187 0
Hospital
Name [1] 283187 0
Te Whatu Ora, Auckland City Hospital
Address [1] 283187 0
Country [1] 283187 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316113 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 316113 0
Ethics committee country [1] 316113 0
New Zealand
Date submitted for ethics approval [1] 316113 0
10/09/2024
Approval date [1] 316113 0
Ethics approval number [1] 316113 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136830 0
Dr Laird Cameron
Address 136830 0
Auckland City Hospital, 2 Park Road, Grafton, Auckland, 1023
Country 136830 0
New Zealand
Phone 136830 0
+64 220144204
Fax 136830 0
Email 136830 0
[email protected]
Contact person for public queries
Name 136831 0
Laird Cameron
Address 136831 0
Auckland City Hospital, 2 Park Road, Grafton, Auckland, 1023
Country 136831 0
New Zealand
Phone 136831 0
+64 220144204
Fax 136831 0
Email 136831 0
[email protected]
Contact person for scientific queries
Name 136832 0
Laird Cameron
Address 136832 0
Auckland City Hospital, 2 Park Road, Grafton, Auckland, 1023
Country 136832 0
New Zealand
Phone 136832 0
+64 220144204
Fax 136832 0
Email 136832 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not appropriate to share data publicly in this study.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.