Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000565347
Ethics application status
Approved
Date submitted
18/04/2017
Date registered
24/04/2017
Date last updated
24/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Targeting support service information for rural men affected by cancer
Scientific title
Targeting support service information for rural people affected by cancer: does making information rural- and gender-specific improve the perceived accessibility of psychosocial services?
Secondary ID [1] 291520 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 302713 0
Psychosocial service use 302714 0
Condition category
Condition code
Cancer 302234 302234 0 0
Any cancer
Public Health 302408 302408 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1
Rural-targeted

The 12-page targeted brochure detailed 13 specific services (i.e., Cancer Council 13 11 20; supportive accommodation; transport; Country Cancer Support website; phone, letter, email, website and in-person information; counselling; online and in-person peer support; telephone or internet, and in-person, support groups; financial assistance; financial planning referral, and; legal referral) for rural people affected by cancer and included a telephone helpline fridge magnet. The appropriate contact details, availability, and a brief description were provided for each service. The targeting modifications were made using strategies for cultural appropriateness for population subgroups, with additional input provided by a panel of experienced social workers that worked with the target population. Following the panel’s recommendation, language used was informal, and referred to ‘country’ rather than “rural” needs. The brochure was delivered in a sealed, opaque envelope along with pre- and immediate-post questionnaires by supportive accommodation or research staff, or via post; participants were asked to read the brochure carefully after completing Time 1 measures (baseline, prior to intervention material exposure).

Arm 2
Rural- and male-targeted

As above, a 12-page targeted brochure detailed 13 specific services (i.e., Cancer Council 13 11 20; supportive accommodation; transport; Country Cancer Support website; phone, letter, email, website and in-person information; counselling; online and in-person peer support; telephone or internet, and in-person, support groups; financial assistance; financial planning referral, and; legal referral) for rural men affected by cancer and included a telephone helpline fridge magnet. The appropriate contact details, availability, and a brief description were provided for each service. The targeting modifications were made using strategies for cultural appropriateness for population subgroups, with additional input provided by a panel of experienced social workers that worked with the target population. Consistent with previous description in the literature, coping was further emphasised as an active, solution-focused process in the targeted rural male brochure. The brochure was delivered in a sealed, opaque envelope along with pre- and immediate-post questionnaires by supportive accommodation or research staff, or via post; participants were asked to read the brochure carefully after completing Time 1 measures (baseline, prior to intervention material exposure).
Intervention code [1] 297670 0
Behaviour
Comparator / control treatment
Arm 3

The 12-page existing "Cancer? We can help" (CWCH) control brochure, developed by Cancer Council SA, detailed 13 specific services as in the intervention arms (i.e., Cancer Council 13 11 20; supportive accommodation; transport; Country Cancer Support website; phone, letter, email, website and in-person information; counselling; online and in-person peer support; telephone or internet, and in-person, support groups; financial assistance; financial planning referral, and; legal referral) for people affected by cancer generally (i.e., it was not further targeted) and included a telephone helpline fridge magnet. The appropriate contact details, availability, and a brief description were provided for each service. All brochures were comparable in length, format and readability. The brochure was delivered in a sealed, opaque envelope along with pre- and immediate-post questionnaires by supportive accommodation or research staff, or via post; participants were asked to read the brochure carefully after completing Time 1 measures (baseline, prior to control material exposure), even if they thought they had seen it before.
Control group
Active

Outcomes
Primary outcome [1] 301712 0
Change in attitudes to seeking help after cancer (as measured by the positive attitudes subscale of the Attitudes to Seeking Help After Cancer questionnaire; Steginga et al., 2008).
Timepoint [1] 301712 0
Baseline: prior to exposure of materials.
Follow-up (second post-test): approximately 24 hours following exposure to materials.
Secondary outcome [1] 333883 0
Change in attitudes to seeking help after cancer (as measured by the behavioural intention and negative attitudes subscales of the Attitudes to Seeking Help After Cancer questionnaire; Steginga et al., 2008).
Timepoint [1] 333883 0
Baseline: prior to exposure of materials.
Follow-up (second post-test): approximately 24 hours following exposure to materials.
Secondary outcome [2] 333884 0
Change in mean perceived isolation scores (original measure, designed specifically for this study).
Timepoint [2] 333884 0
Baseline: prior to exposure of materials.
Follow-up (second post-test): approximately 24 hours following exposure to materials.
Secondary outcome [3] 333955 0
Mean perceived information relevance, as measured using the adapted questionnaire of Muylle, Moenaert and Despontin (2004).
Timepoint [3] 333955 0
Immediate post-test: immediately after exposure of materials.

Eligibility
Key inclusion criteria
Living outside of metropolitan Adelaide, South Australia, when not seeking medical treatment; a guest (or recent guest) at one of Cancer Council SA’s supportive accommodation lodges while receiving treatment for a diagnosis of cancer (i.e., a person with a diagnosis of cancer), or while supporting a person diagnosed with cancer (i.e., a support person; e.g., partner, family member, close friend); able to read and write in English; able to give informed consent to participate in the research.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participant feels psychologically or physically incapable of participating in the research.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Between-group, complete case and intent-to-treat analyses were used at the bivariate and multivariate level to examine the effect of brochure condition.

Power analysis was conducted prior to the study in order to estimate the required sample size. The initial sample size calculation suggested at least 159 participants (n = 53 per group) would be required for the study, assuming statistical power of .8 and an alpha level of .05, to be able to detect effects of a medium size (Faul, Erdfelder, Lang, & Buchner, 2007).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/06/2015
Date of last participant enrolment
Anticipated
Actual
29/09/2015
Date of last data collection
Anticipated
Actual
30/09/2015
Sample size
Target
159
Accrual to date
Final
114
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 296010 0
Other Collaborative groups
Name [1] 296010 0
Freemasons Foundation Centre for Men's Health
Country [1] 296010 0
Australia
Funding source category [2] 296159 0
University
Name [2] 296159 0
University of Adelaide
Country [2] 296159 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
School of Psychology
Faculty of Health Sciences
University of Adelaide
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 295061 0
None
Name [1] 295061 0
Address [1] 295061 0
Country [1] 295061 0
Other collaborator category [1] 279523 0
Charities/Societies/Foundations
Name [1] 279523 0
Cancer C0uncil SA
Address [1] 279523 0
202 Greenhill Road
Eastwood SA 5063
Country [1] 279523 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297271 0
University of Adelaide School of Psychology Human Research Ethics Subcommittee
Ethics committee address [1] 297271 0
Ethics committee country [1] 297271 0
Australia
Date submitted for ethics approval [1] 297271 0
10/04/2015
Approval date [1] 297271 0
22/04/2015
Ethics approval number [1] 297271 0
15/56

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

Contacts
Principal investigator
Name 73534 0
Mr Nathan Harrison
Address 73534 0
Flinders Centre for Innovation in Cancer
GPO Box 2100
Adelaide SA 5001
Country 73534 0
Australia
Phone 73534 0
+61 4 1348 4751
Fax 73534 0
Email 73534 0
[email protected]
Contact person for public queries
Name 73535 0
Nathan Harrison
Address 73535 0
Flinders Centre for Innovation in Cancer
GPO Box 2100
Adelaide SA 5001
Country 73535 0
Australia
Phone 73535 0
+61 4 1348 4751
Fax 73535 0
Email 73535 0
[email protected]
Contact person for scientific queries
Name 73536 0
Nathan Harrison
Address 73536 0
Flinders Centre for Innovation in Cancer
GPO Box 2100
Adelaide SA 5001
Country 73536 0
Australia
Phone 73536 0
+61 4 1348 4751
Fax 73536 0
Email 73536 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.