Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001259831
Ethics application status
Approved
Date submitted
28/11/2012
Date registered
30/11/2012
Date last updated
22/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of a promotional DVD on bowel screening uptake for
Maori and Pacific within the Bowel Screening Pilot
Scientific title
Maori and Pacific bowel screening invitees receiving a promotional DVD compared to usual care reminder processes; impact on screening uptake.
Secondary ID [1] 281597 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Participation in a bowel screening pilot 287880 0
Condition category
Condition code
Public Health 288246 288246 0 0
Health promotion/education
Oral and Gastrointestinal 288260 288260 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A six minute promotional DVD is currently being introduced in the Waitemata DHB bowel screening pilot. The DVD is being offered in addition to usual care. ). Usual care is a standard reminder letter, and for priority groups (Maori, Pacific and Asian), also a phone call follow-up from a culturally appropriate outreach co-ordinator located in the bowel screening pilot. The Data Manager estimates that approximately 50% of priority group participants are able to be reached with 3x phone follow up attempts. There will be no change to usual care for any participant group.

The DVD shows a well known local Maori couple (kaumatua Pio and whaea Chrissy Jacobs) telling the story of whaea Chrissy’s recent experience of bowel screening, and being screened positive (having a positive test followed by a colonoscopy). The DVD is narrated by ex-All Black Frano Botica, and includes a small amount of educational commentary on how to participate in bowel screening, and how to return the test kit (for example labelling and postage details). The DVD is intended to be watched in participant's own home, in their own time, when it is convenient for them, on their own DVD playing equipment.

The DVD was designed by the Community Awareness Raising team in the bowel screening pilot to be a culturally appropriate for Maori. The DVD was developed with the intention to promote bowel screening and to motivate invitees to participate by returning their test kits.

The study will run for approximately a year (calculated on the number of Maori and Pacific people to be invited in the remainder of the current screening round), in order to reach the numbers suggested by the power calculation (4600 - 2600 Maori and 2000 Pacific).
Intervention code [1] 286125 0
Early detection / Screening
Intervention code [2] 286137 0
Prevention
Comparator / control treatment
Those screening invitees who do not respond to the initial invitation are offered usual care. Usual care is to be sent a reminder letter at four weeks, and for priority groups (including Maori and Pacific), a telephone follow-up is also attempted in usual care (approximately 50% of these groups are also reached by phone as noted previously).

The study will run for approximately a year.
Control group
Active

Outcomes
Primary outcome [1] 288433 0
Difference in uptake between those who receive the DVD and those who do not.

The bowel screening pilot involves self-testing faecal matter in the participants own home with the supplied test kit, sealing the kit as instructed, labelling it (including barcode), signing the consent form and returning the kit in the supplied sealed bag in the post direct to the laboratory.

Uptake as an outcome in this study refers to participation in the bowel screening pilot by return of the test kit. The purpose of the reminder letter (and the DVD as an intervention at this point) is to encourage people to participate in bowel screening.

Uptake (or participation) is routinely measured in the bowel screening pilot, when a kit is received by the laboratory. It is measured at 4 weeks post invitation in order to generate a list of those who have not responded to be followed-up (as part of usual care) with a reminder letter and phone calls (for priority groups). Uptake is then measured continuously after that; no further reminders are sent by participants are able to send their test kit in to be analysed at any time after their reminder letter.

For the purposes of this study the Data Manager has been asked to provide the researchers the proportion of test kits returned (the uptake) at 6 weeks post reminder.
Timepoint [1] 288433 0
At 4 weeks post initial invitation a reminder letter is sent out by the bowel screening pilot. The DVD will be included with this mail-out.

Uptake of screening will be assessed at 6 weeks post reminder letter/DVD mail-out.

The trial will recruit for approximately one year.
Secondary outcome [1] 300148 0
Difference in the rate of spoiled kits returned between those who receive the DVD and those who do not. Spoiled kits are those with labelling or collection issues affecting the ability for the laboratory to process the sample.
Timepoint [1] 300148 0
One year.

Eligibility
Key inclusion criteria
1. Bowel screening pilot invitees (male or female Waitemata DHB residents aged 50-69 year old, who are eligible for publically funded healthcare).
2. Non responders to the initial invitation at four weeks
3. Maori or Pacific
Minimum age
50 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All other ethnic groups.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
For the remainder of the first screening round of the bowel screening pilot (approximately a year) all Maori and Pacific invitees who are sent a reminder letter will be randomised into receiving the DVD or not receiving the DVD.

Allocation is not concealed from the bowel screening pilot (who need to manually separate reminder letters by ethnicity in order to add the DVD to the mail-out). Allocation is concealed from the researchers who will not have any identifiable data on the participants, and so will not know who is allocated to the groups).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by week of reminder letter generation, ie DVDs will be included for all those Maori and Pacific people receiving reminder letters in one week, and no DVDs included the following week.

This form of randomisation (quasi-randomisation) appears to be the only practical way to allocate groups (and for the bowel screening pilot to match the group with the uptake) within the pilot. Discussions were held within the research team and with the Data Manager about the possibility of using randomisation software at the point where reminder letters are separated manually by ethnicity however this will add a whole series of manual steps for the bowel screening pilot for which we would have to justify extra resources (this study is funded within baseline funding allocation for the pilot).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The impact on Maori and Pacific will be examined in parallel.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2013
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
31/12/2013
Date of last data collection
Anticipated
Actual
31/07/2014
Sample size
Target
4600
Accrual to date
Final
5277
Recruitment outside Australia
Country [1] 4695 0
New Zealand
State/province [1] 4695 0

Funding & Sponsors
Funding source category [1] 286403 0
Other
Name [1] 286403 0
Bowel screening pilot - Waitemata DHB
Country [1] 286403 0
New Zealand
Primary sponsor type
Individual
Name
Dr Debbie Holdsworth
Address
Chief Planning Officer and Chair of the Bowel Screening Pilot Steering Committee
Waitemata DHB, Planning and Funding
Level 2, 15 Shea Terrace
Private Bag 93-503
Takapuna 0740
Auckland
Country
New Zealand
Secondary sponsor category [1] 285195 0
None
Name [1] 285195 0
Address [1] 285195 0
Country [1] 285195 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288470 0
Health and Disability Ethics Committee
Ethics committee address [1] 288470 0
Ethics committee country [1] 288470 0
New Zealand
Date submitted for ethics approval [1] 288470 0
30/11/2012
Approval date [1] 288470 0
15/12/2012
Ethics approval number [1] 288470 0

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

Contacts
Principal investigator
Name 34991 0
Dr Peter Sandiford
Address 34991 0
Private Bag 93-503 Takapuna Auckland
Country 34991 0
New Zealand
Phone 34991 0
+64 9 4868920
Fax 34991 0
Email 34991 0
[email protected]
Contact person for public queries
Name 18238 0
Dr Peter Sandiford
Address 18238 0
Planning and Funding
Waitemata DHB
Level 1, 15 Shea Terrace
Private Bay 93-503
Takapuna 0740
Auckland
Country 18238 0
New Zealand
Phone 18238 0
+64 9 486 8920 x2923
Fax 18238 0
Email 18238 0
[email protected]
Contact person for scientific queries
Name 9166 0
Dr Peter Sandiford
Address 9166 0
Planning and Funding
Waitemata DHB
Level 1, 15 Shea Terrace
Private Bay 93-503
Takapuna 0740
Auckland
Country 9166 0
New Zealand
Phone 9166 0
+64 9 486 8920 x2923
Fax 9166 0
Email 9166 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.