ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

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

Condition category

Condition code

Cancer

Cervical (cervix)

Cancer

Ovarian and primary peritoneal

Cancer

Womb (Uterine or endometrial cancer)

Cancer

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Cumulative data will be assessed 3 months after the final participant has been enrolled.

Primary outcome [2]

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]

Cumulative data will be assessed 3 months after the final participant has been enrolled.

Primary outcome [3]

Identify patterns and themes in the responses to semi-structured interviews of 20-30 study participants.

Timepoint [3]

Interviews will be undertaken as soon as possible after (and within 6 months of) clinical data being collected

Secondary outcome [1]

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]

Cumulative data will be assessed 3 months after the final participant has been enrolled.

Secondary outcome [2]

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]

Cumulative data will be assessed 3 months after the final participant has been enrolled.

Secondary outcome [3]

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]

Cumulative data will be assessed 3 months after the final participant has been enrolled.

Secondary outcome [4]

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]

Cumulative data will be assessed 3 months after the final participant has been enrolled.

Secondary outcome [5]

Proportion of participants, who meet referral criteria, who are not discussed at an MDM meeting within 14 days of referral.

Timepoint [5]

Cumulative data will be assessed 3 months after the final participant has been enrolled.

Secondary outcome [6]

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]

Cumulative data will be assessed 3 months after the final participant has been enrolled.

Secondary outcome [7]

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]

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?

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

Health Research Council of New Zealand, Level 1 South Tower, 110 Symonds Street, Grafton, Auckland 1010

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Northern B Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health Health and Disability Ethics Committees PO Box 5013 Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/03/2024

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Compared with non-Maori, Maori and Pasifika wahine have a higher incidence and mortality from gynaecological cancer in Aotearoa NZ. Of particular concern, the incidence of endometrial cancer in young women in Aotearoa NZ is increasing faster than anywhere else in the world and the greatest burden of this lies in Maori and Pasifika wahine. Inequities can occur at any stage along the pathway from health to gynaecological cancer and also between different ethnicities and geographical regions. This research study will identify the cultural, geographical, and timeline inequities in the journey from health to gynaecological cancer across all of Aotearoa NZ. Through investigation of health data and interviews with wahine newly-diagnosed with gynaecological cancer, we will document the ethnicity, timetable, and geographical location, of presentations to health care services, clinical investigations, stage and disease burden at diagnosis, and consider barriers to accessing health care or investigations.

Trial website

Trial related presentations / publications

Public notes

Timely access to services as specified in the New Zealand Faster Cancer Treatment (FCT) targets and proposed in the Standards of service provision for gynaecological cancer patients in New Zealand (Standards 1, 2, 6, 12, 15:(references 1-4)
Standard 1
•	Women referred urgently with a high suspicion of gynaecological cancer have their first specialist assessment (FSA) within 14 days.
•	Women with a confirmed diagnosis of gynaecological cancer receive their first treatment within 31 days of the decision to treat.
•	Women referred urgently with a high suspicion of gynaecological cancer receive their first cancer treatment within 62 days.
•	Women needing radiotherapy or systemic therapy receive their first treatment within four weeks of the decision to treat.
Standard 2
•	Women with postmenopausal bleeding or clinical suspicion of a pelvic mass are offered an appointment for a pelvic ultrasound that falls within two weeks of the date of receipt of that referral.
Standard 6
•	Women with a new diagnosis of gynaecological malignancy are offered an appointment for radiological investigations required for treatment planning that falls within two weeks of the date of receipt of that referral.
Standard 12
•	The MDM discussion takes place within 14 days of referral (provided referral criteria are met).
Standard 15
•	Women with a diagnosis of gynaecological cancer 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.
Pathology Review Good Practice Point 3.3
•	Provisional or final pathology reports are communicated with the lead clinician within 10 working days of the specimen being taken.

REFERENCES
1.	Askew C, Gangji A. Gynaecological cancer pathway for faster cancer treatment: a clinical audit. N Z Med J. 2016;129:79-89.
2.	Ha M, Gangji A. Faster Cancer Treatment pathway in gynaecological malignancy: a repeat clinical audit. N Z Med J. 2018;131:45-55.
3.	Cherry RJ, Gangji A. Gynaecological cancer pathway for faster cancer treatment: a repeat clinical audit. N Z Med J. 2022;135:74-85.
4.	Standards of Service Provision for Gynaecological Cancer Patients in New Zealand - Provisional. 2013. Wellington: Ministry of Health.  ^https://cancerhub.net/wp-content/uploads/2018/02/standards-of-service-provision-gynaecological-cancer-patients-jan14.doc

Contacts

Principal investigator

Name

Dr Carrie Innes

Address

Department of Obstetrics and Gynaecology, University of Otago, Christchurch, 2 Riccarton Ave, PO Box 4345, Christchurch 8140, New Zealand

Country

New Zealand

Phone

+64 3 364 4625

Fax

carrie.innes@otago.ac.nz

Contact person for public queries

Name

Carrie Innes

Address

Department of Obstetrics and Gynaecology, University of Otago, Christchurch, 2 Riccarton Ave, PO Box 4345, Christchurch 8140, New Zealand

Country

New Zealand

Phone

+64 3 364 4625

Fax

carrie.innes@otago.ac.nz

Contact person for scientific queries

Name

Carrie Innes

Address

Department of Obstetrics and Gynaecology, University of Otago, Christchurch, 2 Riccarton Ave, PO Box 4345, Christchurch 8140, New Zealand

Country

New Zealand

Phone

+64 3 364 4625

Fax

carrie.innes@otago.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details
21332	Study protocol	Carrie.innes@otago.ac.nz
21334	Informed consent form	Carrie.innes@otago.ac.nz
21335	Ethical approval	Carrie.innes@otago.ac.nz
21336	Clinical study report	carrie.innes@otago.ac.nz
21337	Other	carrie.innes@otago.ac.nz	Participant Information Sheet, Data management pla... [More Details]

Results publications and other study-related documents

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