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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To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12619000805178

Ethics application status

Approved

Date submitted

27/05/2019

Date registered

3/06/2019

Date last updated

10/12/2019

Date data sharing statement initially provided

3/06/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Does timely care matter to lung cancer patients? A sub-study of the Continuous Improvement in Care – Cancer (CIC-Cancer) Project.

Scientific title

Does timely care matter to lung cancer patients? A sub-study of the Continuous Improvement in Care – Cancer (CIC-Cancer) Project.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1234-1724

Trial acronym

Linked study record

The Continuous Improvement in Care - Cancer (CIC - Cancer) Project.
Principle Investigator: Professor Christobel Saunders, University of Western Australia.

Health condition

Health condition(s) or problem(s) studied:

Lung cancer

Condition category

Condition code

Cancer

Lung - Non small cell

Cancer

Lung - Small cell

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

A cohort of lung cancer patients will be observed from initial abnormal CT scan all the way through until commencing treatment. Various time intervals, including referral - review and referral - treatment will be measured for each patient. At the time of treatment commencement, a patient satisfaction survey will be administered.
Patients will only be followed up until the time of their first treatment.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Patient satisfaction, as measured by the Patient Satisfaction with Cancer Care survey. This is an 18 point survey that was developed and validated in an 891 American cancer patient cohort in 2011 and covers several domains of patient satisfaction, including access to and co-ordination of care and relationships and communication with health professionals.

Reference: Jean-Pierre P, Fiscella K, Freund K et al. Structural and reliability analysis of a patient satisfaction with cancer-related care measure: A multi-site patient navigation research program study. Cancer. 2011; 117(4):854-861.

Timepoint [1]

Measured within one week before or after cancer treatment commencement.

Secondary outcome [1]

Patient perception of the timeliness of their cancer care.
Patients will be asked: “Do you feel the time from your initial referral to starting treatment has been 1 = Much too quick, 2 = A bit too quick, 3 = Just right, 4 = A bit too slow, 5 = Much too slow.”

Timepoint [1]

Measured within one week before or after cancer treatment commencement.

Eligibility

Key inclusion criteria

1) Diagnosis of primary lung cancer
2) Receiving active antineoplastic therapy
3) Reviewed by the Respiratory Service at participating hospitals during the study period

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1) Patients unable to answer survey questions
2) Patients with mesothelioma.

Study design

Purpose

Psychosocial

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Data will be summarised using means (standard deviations) or medians (interquartile ranges) for continuous variables (as appropriate for the distribution) and frequency (percentages) for categorical variables. The relationship between the PSCC and timeliness of care will be considered using appropriate generalised linear models. These relationships will be estimated in isolation and following adjustment for potential confounding factors, including age, medical co-morbidities and performance status.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

15/06/2019

Actual

11/10/2019

Date of last participant enrolment

Anticipated

15/06/2021

Actual

Date of last data collection

Anticipated

1/07/2021

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Royal Perth Hospital - Perth

Recruitment hospital [2]

St John of God Midland Public Hospital - Midland

Recruitment postcode(s) [1]

6000 - Perth

Recruitment postcode(s) [2]

6056 - Midland

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Perth Hospital

Address [1]

197 Wellington Street
Perth WA 6000

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

St John of God Healthcare Midland Campus

Address [2]

1 Clayton Street
Midland WA 6056

Country [2]

Australia

Primary sponsor type

Hospital

Name

Respiratory Department, St John of God Healthcare

Address

St John of God Healthcare Midland Campus
1 Clayton Street
Midland WA 6056

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Metropolitan Health Service HREC

Ethics committee address [1]

Fiona Stanley Hospital 
11 Robin Warren Drive 
Murdoch WA 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/05/2019

Approval date [1]

21/05/2019

Ethics approval number [1]

Ethics committee name [2]

St John of God Health Care Human Research Ethics Committee

Ethics committee address [2]

St John of God Health Care Midland Campus
1 Clayton Street
Midland WA 6056

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

21/07/2019

Approval date [2]

02/09/2019

Ethics approval number [2]

1578

Summary

Brief summary

Lung cancer is the leading cause of cancer-related mortality and morbidity in Australia, with more than 8000 Australians predicted to die in 2018 alone. Due to the poor outcomes experiences by many lung cancer patients, clinicians attempt to provide rapid review, diagnosis and treatment and adhere to the timeframes suggested in the Cancer Council’s Optimal Care Pathway. Whilst scientific end points, such as survival are important, patient reported outcomes, such as quality of life and satisfaction with care are also vital. This move towards more patient-centric care is being championed in Western Australia by the Continuous Improvement in Care – Cancer (CIC-Cancer) Project. 


Are you eligible to take part in this study? 

This study aims to establish if providing guideline-driven care, in terms of timeliness, improves patient satisfaction amongst people with lung cancer. You may be eligible to take part if you have primary lung cancer and are undergoing treatment and have consented to have your clinical information collected by the CIC-Cancer database. 


What does the study involve? 

Patients will be asked to complete an 18 question survey at the time that they start treatment for lung cancer. The survey will assess different areas of patient satisfaction with care, including access to appointments and communication with their doctor. Patients will not be obliged to any other follow up. 


How will involvement in this study help patients with lung cancer? 

This study will help us to validate the Cancer Council Optimal Care Pathway and ensure that striving to achieve rapid review and treatment really is making patients more satisfied with their care.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Phoebe Brownell

Address

St John of God Healthcare Midland Campus
1 Clayton Street
Midland WA 6056

Country

Australia

Phone

+61 411618742

Fax

phoebe.brownell@health.wa.gov.au

Contact person for public queries

Name

Phoebe Brownell

Address

St John of God Healthcare Midland Campus
1 Clayton Street
Midland WA 6056

Country

Australia

Phone

+61 411618742

Fax

phoebe.brownell@health.wa.gov.au

Contact person for scientific queries

Name

Phoebe Brownell

Address

St John of God Healthcare Midland Campus
1 Clayton Street
Midland WA 6056

Country

Australia

Phone

+61 411618742

Fax

phoebe.brownell@health.wa.gov.au

Data sharing statement

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

Yes

What data in particular will be shared?

Only responses to the PSCC survey will be shared.
All other patient information is at the discretion of the CIC-Cancer database.

When will data be available (start and end dates)?

Starting at the end of data collection.
Data will be available for 7 years.

Available to whom?

Anyone who wishes to access.

Available for what types of analyses?

Any type of analysis.

How or where can data be obtained?

By approval from the Principle Investigator.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2198	Study protocol					377667-(Uploaded-27-05-2019-22-54-39)-Study-related document.docx

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.

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