Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001467820
Ethics application status
Approved
Date submitted
28/09/2021
Date registered
27/10/2021
Date last updated
8/11/2022
Date data sharing statement initially provided
27/10/2021
Date results information initially provided
27/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
CANcer patients’ perspectives on coronavirus VACCination Survey (CANVACCS) research project
Scientific title
Australian adult cancer, diabetes and multiple sclerosis patients' perspectives on SARS-CoV-2 COVID-19 vaccination
Secondary ID [1] 305421 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CANVACCS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer
 323790 0
COVID-19 vaccination
 323792 0
Diabetes 323793 0
Multiple Sclerosis 323794 0
Condition category
Condition code
Cancer 321302 321302 0 0
Any cancer
Metabolic and Endocrine 321303 321303 0 0
Diabetes
Neurological 321304 321304 0 0
Multiple sclerosis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
At nine different health services across Australia, patients diagnosed with any cancer are invited to take part in an anonymous online survey on a single occasion. The 15-minute survey explores patient perspectives on the coronavirus vaccination. Patients are asked how likely they are to accept a COVID-19 vaccine and their views on the benefits and risks of vaccination. It will also collect limited details about patient demographics and cancer diagnosis.

To compare perspectives between different chronic illnesses, the online survey was also conducted with patients diagnosed with the following chronic illnesses: 1) diabetes and; 2) multiple sclerosis. These were conducted at four and two participating health services, respectively.

Upon completion of the survey, patients are invited to register their interest to be randomly selected for a single occasion one-on-one semi-structured interview. The interview will be conducted by a member of the research team and it explores patient views and experiences on COVID-19 vaccination and chronic illness in more detail. A total of 35 patients will be randomly selected for the interview: 25 cancer patients, five diabetes patients, and five MS patients. Each interview will take approximately 30 to 60 minutes and will be conducted either over the telephone or with a Zoom online videocall (cameras turned off) during business hours.
Intervention code [1] 321823 0
Not applicable
Comparator / control treatment
Patients diagnosed with diabetes will be surveyed and potentially interviewed, in an identical manner to the cancer and multiple sclerosis groups.
Control group
Active

Outcomes
Primary outcome [1] 329083 0
Assess expressed intent to accept a COVID-19 vaccine using an Oxford COVID-19 vaccine-specific scale (Freeman et al, 2020).
Timepoint [1] 329083 0
At survey completion.
Primary outcome [2] 329089 0
Assess expressed COVID-19 vaccine complacency and confidence beliefs using an Oxford COVID-19 vaccine-specific scale (Freeman et al. 2020).
Timepoint [2] 329089 0
At survey completion.
Primary outcome [3] 329267 0
Assess chronic disease impact on attitudes towards COVID-19 vaccination using a self-developed six-item scale.
Timepoint [3] 329267 0
At survey completion.
Secondary outcome [1] 401963 0
Nil
Timepoint [1] 401963 0
Nil

Eligibility
Key inclusion criteria
Cancer patient cohort
• Aged 18 years or over
• Diagnosed with cancer and receiving oncology care or services from one of the participating health services.

Diabetes patient cohort
• Aged 18 years or over
• Diagnosed with diabetes and receiving diabetes care or services from one of the participating health services.

Multiple sclerosis (MS) patient cohort
• Aged 18 years or over
• Diagnosed with MS and receiving MS care or services from one of the participating health services.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to complete the survey due to limited English skills.
Patients with limited English skills can be included if a family member or carer can assist them with completing the survey.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Three cohorts:
• Patients diagnosed with cancer
• Patients diagnosed with diabetes
• Patients diagnosed with multiple sclerosis

As this is an exploratory study on a rapidly evolving topic, no statistical power calculation was used.

Between-group statistical tests will be used to analyse different survey items between the three patient cohorts. Within-group and association statistical tests will be used to analyse different survey items within each cohort.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/06/2021
Date of last participant enrolment
Anticipated
Actual
5/10/2021
Date of last data collection
Anticipated
30/11/2021
Actual
4/11/2021
Sample size
Target
5000
Accrual to date
Final
4683
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 20615 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 20616 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [3] 20617 0
Dandenong Hospital - Dandenong
Recruitment hospital [4] 20618 0
Casey Hospital - Berwick
Recruitment hospital [5] 20619 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [6] 20620 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [7] 20621 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [8] 20623 0
Nambour General Hospital - Nambour
Recruitment hospital [9] 20624 0
Gympie Hospital - Gympie
Recruitment hospital [10] 20625 0
Caloundra Hospital - Caloundra
Recruitment hospital [11] 20626 0
Icon Cancer Centre Hobart - Hobart
Recruitment hospital [12] 20627 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [13] 20628 0
Border Medical Oncology - Albury
Recruitment hospital [14] 20630 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 35406 0
3168 - Clayton
Recruitment postcode(s) [2] 35407 0
3165 - East Bentleigh
Recruitment postcode(s) [3] 35408 0
3175 - Dandenong
Recruitment postcode(s) [4] 35409 0
3806 - Berwick
Recruitment postcode(s) [5] 35410 0
3550 - Bendigo
Recruitment postcode(s) [6] 35411 0
3844 - Traralgon
Recruitment postcode(s) [7] 35412 0
4575 - Birtinya
Recruitment postcode(s) [8] 35414 0
4560 - Nambour
Recruitment postcode(s) [9] 35415 0
4570 - Gympie
Recruitment postcode(s) [10] 35416 0
4551 - Caloundra
Recruitment postcode(s) [11] 35417 0
7000 - Hobart
Recruitment postcode(s) [12] 35418 0
2010 - Darlinghurst
Recruitment postcode(s) [13] 35419 0
2640 - Albury
Recruitment postcode(s) [14] 35421 0
2560 - Campbelltown
Recruitment postcode(s) [15] 35590 0
2250 - North Gosford
Recruitment postcode(s) [16] 35591 0
2165 - Fairfield

Funding & Sponsors
Funding source category [1] 309780 0
Hospital
Name [1] 309780 0
Monash Health
Country [1] 309780 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 310811 0
None
Name [1] 310811 0
Address [1] 310811 0
Country [1] 310811 0
Other collaborator category [1] 281996 0
Hospital
Name [1] 281996 0
Bendigo Health
Address [1] 281996 0
100 Barnard Street,
Bendigo VIC 3550
Country [1] 281996 0
Australia
Other collaborator category [2] 281997 0
Hospital
Name [2] 281997 0
Latrobe Regional Hospital
Address [2] 281997 0
10 Village Ave
Traralgon VIC 3844
Country [2] 281997 0
Australia
Other collaborator category [3] 281998 0
Hospital
Name [3] 281998 0
Sunshine Coast Hospital and Health Service
Address [3] 281998 0
6 Doherty Street
Birtinya QLD 4575
Country [3] 281998 0
Australia
Other collaborator category [4] 281999 0
Other
Name [4] 281999 0
Central Coast Haematology
Address [4] 281999 0
Jarrett Street Specialist Centre
Suite 5/14-18 Jarrett Street
North Gosford NSW 2250
Country [4] 281999 0
Australia
Other collaborator category [5] 282000 0
Hospital
Name [5] 282000 0
Integrated Clinical Oncology Network Pty Ltd (Icon) - Icon Cancer Centre Hobart
Address [5] 282000 0
Icon Cancer Centre Hobart
2 Melville Street, Hobart
TAS 2250
Country [5] 282000 0
Australia
Other collaborator category [6] 282001 0
Hospital
Name [6] 282001 0
St Vincent's Hospital Sydney Limited
Address [6] 282001 0
390 Victoria Street
Darlinghurst NSW 2010
Country [6] 282001 0
Australia
Other collaborator category [7] 282002 0
Other
Name [7] 282002 0
Border Medical Oncology Research Unit Pty Ltd
Address [7] 282002 0
Level 1, Albury-Wodonga Research Cancer Centre,
201-239 Borella Road, Albury, NSW, 2640
Country [7] 282002 0
Australia
Other collaborator category [8] 282003 0
Hospital
Name [8] 282003 0
South Western Sydney Local Health District - Campbelltown Hospital
Address [8] 282003 0
Macarthur Cancer Therapy Centre, Campbelltown Hospital via Parkside Crescent
Campbelltown NSW 2560
Country [8] 282003 0
Australia
Other collaborator category [9] 282024 0
Individual
Name [9] 282024 0
Dr David Hoffman
Address [9] 282024 0
Dr David Hoffman Endocrinology Clinic
5/14-16 Court Road
Fairfield, NSW 2165
Country [9] 282024 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309533 0
Monash Human Research & Ethics Committee
Ethics committee address [1] 309533 0
Research Support Services
Monash Health
Level 2, i Block
Monash Medical Centre
Clayton VIC 3168
Ethics committee country [1] 309533 0
Australia
Date submitted for ethics approval [1] 309533 0
02/06/2021
Approval date [1] 309533 0
23/06/2021
Ethics approval number [1] 309533 0
RES-21-0000-364L – 76466

Summary
Brief summary
This study will explore the perspectives of patients with a chronic disease on the COVID-19 vaccination.


Who is this study for?
You may be eligible to take part if you meet all of the following criteria:
• Aged 18 and above
• Diagnosed with any of the following chronic diseases: a) cancer; b) diabetes and; c) multiple sclerosis
• Receiving care or services for the chronic disease from one of the participating health services.

Note: Some health services are only conducting the survey for one of the chronic diseases, please speak with your healthcare team for more information.


Study details
Participants in this study will be invited to complete a short anonymous online survey. The survey asks participants about their views towards the COVID-19 vaccination and how their chronic illness diagnosis may be affect these views. Participants will also be asked about basic non-identifiable information such as age, gender and chronic disease diagnosis. Upon survey completion, participants can register their interest to be randomly selected for a one-on-one interview. The interview will explore the views towards the COVID-19 vaccination in more detail, including where participants have received information about the COVID-19 vaccination.

The data collected from the surveys and interview will provide knowledge of COVID-19 vaccine perspectives in Australian patients diagnosed with a chronic disease. The findings can help health services better understand how to support patients better with various COVID-19 vaccination needs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114486 0
Prof Eva Segelov
Address 114486 0
Monash University,
Wellington Road
Clayton VIC 3800
Country 114486 0
Australia
Phone 114486 0
+61410947444
Fax 114486 0
Email 114486 0
[email protected]
Contact person for public queries
Name 114487 0
Mr Alastair Kwok
Address 114487 0
Monash Health
246 Clayton Rd
Clayton VIC 3168
Country 114487 0
Australia
Phone 114487 0
+613 8572 2584
Fax 114487 0
Email 114487 0
[email protected]
Contact person for scientific queries
Name 114488 0
Prof Eva Segelov
Address 114488 0
Monash University,
Wellington Road
Clayton VIC 3800
Country 114488 0
Australia
Phone 114488 0
+613 8572 2584
Fax 114488 0
Email 114488 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13384Ethical approval  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Disease Influenced Vaccine Acceptance Scale-Six (DIVAS-6): Validation of a Measure to Assess Disease-Related COVID-19 Vaccine Attitudes and Concerns.2023https://dx.doi.org/10.1080/08964289.2022.2082358
EmbaseFactors Influencing COVID-19 Vaccine Hesitancy among Patients with Serious Chronic Illnesses during the Initial Australian Vaccine Rollout: A Multi-Centre Qualitative Analysis Using the Health Belief Model.2023https://dx.doi.org/10.3390/vaccines11020239
EmbaseCOVID-19 Vaccine Status, Intent, Hesitancy, and Disease-Related Beliefs in People with Multiple Sclerosis.2023https://dx.doi.org/10.3390/vaccines11020410
N.B. These documents automatically identified may not have been verified by the study sponsor.