Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000217505p
Ethics application status
Submitted, not yet approved
Date submitted
8/01/2024
Date registered
5/03/2024
Date last updated
5/03/2024
Date data sharing statement initially provided
5/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
JOURNEYS - Where are the inequities in the journey from health to gynaecological cancer in Aotearoa New Zealand?
Scientific title
JOURNEYS - Health care system barriers leading to inequities in the journey from health to gynaecological cancer in Aotearoa New Zealand for people diagnosed in 2024 - 2025
Secondary ID [1] 311433 0
None
Universal Trial Number (UTN)
U1111-1299-2338
Trial acronym
JOURNEYS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gynaecological cancer 332513 0
Condition category
Condition code
Cancer 329197 329197 0 0
Cervical (cervix)
Cancer 329198 329198 0 0
Ovarian and primary peritoneal
Cancer 329199 329199 0 0
Womb (Uterine or endometrial cancer)
Cancer 329200 329200 0 0
Other cancer types

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study will use a descriptive mixed-methods analysis to document the journey of a cohort of people with a newly-diagnosed ovarian, cervical, endometrial, or vulval cancer including their location, timeline of health touch points, and individual stories, told in their own language in a cultural context.

All eligible tangata will be approached by a trained research nurse at the time of their diagnosis (in person, if possible, or by other method such as phone or virtual meeting, if not possible), to obtain consent to access clinical data and separate consent to potentially take part in a future interview.

525 people will be recruited over 12 months including 85 Maori, 85 Pasifika, and 85 rural people. A real-time audit of clinical notes (from primary, secondary, and tertiary care) will be undertaken by a researcher or research nurse. Clinical notes will be used to create a timeline and description of clinical appointments related to their cancer investigation, diagnosis, and treatment.

After completion of study recruitment and analysis of quantitative clinical data, purposive maximum variation sampling will be used to identify 20–30 study participants to undertake a one-off, one-to-one, semi-structured interview of up to 60 minutes duration. The group to be interviewed will include at least 6 Maori, 6 Pacific, and 6 people with remote or low urban accessibility, and selection will be guided by the findings of the quantitative clinical data. People will only be approached (by a trained culturally appropriate researcher or research nurse) if, at time of recruitment, they had provided separate consent to take part in a future interview. A trained culturally appropriate researcher or research nurse will undertake the semi-structured interviews.
Intervention code [1] 327726 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337036 0
Proportion of participants who do not have treatment beginning within 31 days of a decision being made that they will have that treatment (New Zealand Faster Cancer Treatment target 1)
Timepoint [1] 337036 0
Cumulative data will be assessed 3 months after the final participant has been enrolled.
Primary outcome [2] 337037 0
Proportion of participants referred urgently with a high suspicion of gynaecological cancer who do not receive their first cancer treatment within 62 days (New Zealand Faster Cancer Treatment target 2)
Timepoint [2] 337037 0
Cumulative data will be assessed 3 months after the final participant has been enrolled.
Primary outcome [3] 337039 0
Identify patterns and themes in the responses to semi-structured interviews of 20-30 study participants.
Timepoint [3] 337039 0
Interviews will be undertaken as soon as possible after (and within 6 months of) clinical data being collected
Secondary outcome [1] 430441 0
Proportion of participants referred urgently with a high suspicion of gynaecological cancer who do not have their first specialist assessment within 14 days.
Timepoint [1] 430441 0
Cumulative data will be assessed 3 months after the final participant has been enrolled.
Secondary outcome [2] 430442 0
Proportion of participants needing radiotherapy or systemic therapy who do not receive their first treatment within four weeks of the decision to treat.
Timepoint [2] 430442 0
Cumulative data will be assessed 3 months after the final participant has been enrolled.
Secondary outcome [3] 430443 0
Proportion of participants with postmenopausal bleeding or clinical suspicion of a pelvic mass who are not offered an appointment for a pelvic ultrasound that falls within two weeks of the date of receipt of that referral.
Timepoint [3] 430443 0
Cumulative data will be assessed 3 months after the final participant has been enrolled.
Secondary outcome [4] 430444 0
Proportion of participants with a new diagnosis of gynaecological malignancy who are not offered an appointment for radiological investigations required for treatment planning that falls within two weeks of the date of receipt of that referral.
Timepoint [4] 430444 0
Cumulative data will be assessed 3 months after the final participant has been enrolled.
Secondary outcome [5] 430450 0
Proportion of participants, who meet referral criteria, who are not discussed at an MDM meeting within 14 days of referral.
Timepoint [5] 430450 0
Cumulative data will be assessed 3 months after the final participant has been enrolled.
Secondary outcome [6] 430451 0
Proportion of participants with a diagnosis of gynaecological cancer who do not have contact with their gynaecological cancer clinical nurse specialist or other health professional who will help coordinate her care within seven days of receipt of their diagnosis.
Timepoint [6] 430451 0
Cumulative data will be assessed 3 months after the final participant has been enrolled.
Secondary outcome [7] 431835 0
Proportion of participants who do not have their provisional or final pathology reports communicated with the lead clinician within 10 working days of the specimen being taken.
Timepoint [7] 431835 0
Cumulative data will be assessed 3 months after the final participant has been enrolled.

Eligibility
Key inclusion criteria
A new diagnosis of ovarian, cervical, vulval, or endometrial cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwilling or unable to provide informed consent (e.g., due to being too unwell to provide informed consent).

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
The study populations will be described by age, prioritised ethnicity, co-morbidities,[1, 2] NZ socioeconomic deprivation index, urban accessibility [8], cancer type, and stage of cancer at diagnosis. Associations between groups and demographic and clinical characteristics will be tested statistically using chi-square or linear-by-linear tests for categorical or ordinal variables, respectively. Risk ratios versus reference levels will be calculated with 95% confidence intervals for each independent variable using generalised linear regression models. The time from first relevant health contact to diagnosis, will be presented graphically using cumulative distribution plots and summarised in tables by key characteristic variables.

The proportion of people exceeding Aotearoa NZ Faster Cancer treatment targets and current model of practice for diagnosis and treatment of gynaecological cancer timelines will be determined for the whole group and stratified by ethnicity, NZ socioeconomic deprivation index, and urban accessibility. Timeline analyses will be used to identify points of inequity at primary, secondary, and tertiary care levels.

We have based our recruitment ethnicity estimations on 2019 National Cancer registrations [3] which reported 1197 ovarian, cervical, endometrial, or vulval cancer diagnoses. Of these, 15% were Maori and 85% were non-Maori tangata. In addition, our recruitment estimations to assess geographical differences have been informed by Environmental Health Intelligence New Zealand (EHINZ) [4] which indicates that approximately 16% of the total NZ population (and 18% of Maori) live in rural areas. However, study estimates also take into account evidence that incidence of cancer overall is lower among those living in rural areas.[5] Indeed, in our most recent national review of cervical cancer occurrences (2013-2017),[6] we reported that 13% of tangata diagnosed with cervical cancer had a rural home address.

A power analysis was undertaken to determine recruitment targets based on data from our recent national cervical cancer audit.[6] Of 1009 women with a high-grade cytology prior to their diagnosis, 86% of European were diagnosed within 6 months of their high-grade cytology result. In contrast, Maori and Pasifika tangata were nearly twice as likely to have a delay from high-grade cytology to diagnosis of more than 6 months. We used these results as a basis for our sample-size power calculations for a cohort study using OpenEPI.[7] The sample size estimate recommended a reference group sample of 323 tangata and a comparison group sample of 85 tangata (2-sided significance level 95%; 80% power; ratio of sample size 3.83; risk/prevalence ratio of 2, Fleiss with continuity correction). The study will be powered for separate Maori and Pasifika primary outcomes, thus, based on our power analysis, the overall recruitment target will be 525 tangata over a 12-month period and include at least 85 Maori, 85 Pasifika, 85 tangata with a home address indicating low urban accessibility or a more remote classification (as defined by Stats NZ Tatauranga Aotearoa),[8] and 325 non-Maori non-Pasifika tangata.

1. Charlson ME, Carrozzino D, Guidi J, Patierno C. Charlson Comorbidity Index: A Critical Review of Clinimetric Properties. Psychother Psychosom. 2022;91:8-35.
2. Charlson ME, Pompei P, Ales KL, Mackenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40:373-83.
3. Cancer: New registrations and deaths 2019. 2021. Wellington, New Zealand: Ministry of Health. ^https://www.health.govt.nz/publication/new-cancer-registrations-2019
4. Urban–rural profile. EHINZ: Environmental Health Intelligence New Zealand; Access date: 6/11/2022, 2022. Available from:^https://www.ehinz.ac.nz/indicators/population-vulnerability/urbanrural-profile/
5. Robson B, Purdie G, Cormack D. Unequal Impact II: Maori and Non-Maori Cancer Statistics 2002-2006. 2010. Wellington: Ministry of Health.
6. Sykes P, Williman J, Innes C, Hider P. Review of Cervical Cancer Occurrences in relation to Screening History in New Zealand for the years 2013-2017. 2020. Wellington, New Zealand: Ministry of Health. ^https://www.nsu.govt.nz/system/files/resources/cancer-case-review-2013-2017-final-report-29-august-2019.pdf
7. Dean AG, Sullivan KM, Soe MM. OpenEpi: Open Source Epidemiologic Statistics for Public Health, 2013.
8. Urban accessibility – methodology and classification. Wellington, New Zealand: Stats NZ Tatauranga Aotearoa; Access date: 28 October, 2021. Available from:^https://www.stats.govt.nz/methods/urban-accessibility-methodology-and-classification


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
525
Accrual to date
Final
Recruitment outside Australia
Country [1] 26063 0
New Zealand
State/province [1] 26063 0

Funding & Sponsors
Funding source category [1] 315530 0
Government body
Name [1] 315530 0
Health Research Council of New Zealand
Country [1] 315530 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street, Dunedin North, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 317615 0
None
Name [1] 317615 0
Address [1] 317615 0
Country [1] 317615 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314430 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 314430 0
Ethics committee country [1] 314430 0
New Zealand
Date submitted for ethics approval [1] 314430 0
01/03/2024
Approval date [1] 314430 0
Ethics approval number [1] 314430 0

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

Contacts
Principal investigator
Name 131554 0
Dr Carrie Innes
Address 131554 0
Department of Obstetrics and Gynaecology, University of Otago, Christchurch, 2 Riccarton Ave, PO Box 4345, Christchurch 8140, New Zealand
Country 131554 0
New Zealand
Phone 131554 0
+64 3 364 4625
Fax 131554 0
Email 131554 0
[email protected]
Contact person for public queries
Name 131555 0
Carrie Innes
Address 131555 0
Department of Obstetrics and Gynaecology, University of Otago, Christchurch, 2 Riccarton Ave, PO Box 4345, Christchurch 8140, New Zealand
Country 131555 0
New Zealand
Phone 131555 0
+64 3 364 4625
Fax 131555 0
Email 131555 0
[email protected]
Contact person for scientific queries
Name 131556 0
Carrie Innes
Address 131556 0
Department of Obstetrics and Gynaecology, University of Otago, Christchurch, 2 Riccarton Ave, PO Box 4345, Christchurch 8140, New Zealand
Country 131556 0
New Zealand
Phone 131556 0
+64 3 364 4625
Fax 131556 0
Email 131556 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
21332Study protocol  [email protected]
21334Informed consent form  [email protected]
21335Ethical approval  [email protected]
21336Clinical study report  [email protected]
21337Other  [email protected] Participant Information Sheet, Data management pla... [More Details]



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.