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Trial registered on ANZCTR


Registration number
ACTRN12614000702617
Ethics application status
Approved
Date submitted
20/06/2014
Date registered
3/07/2014
Date last updated
19/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving quality of patient centred care in cancer
Scientific title
Improving cancer treatment systems: effect of a consumer action model for cancer patients receiving chemotherapy on unmet supportive care needs and quality of life
Secondary ID [1] 283725 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 290690 0
Condition category
Condition code
Cancer 291061 291061 0 0
Any cancer
Public Health 292657 292657 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hospitals involved in this study will participate in a quality improvement intervention, based on the Breakthrough Series. The Breakthrough Series is a collaborative model of learning developed by the Institute for Healthcare Improvement (IHI). This model focuses on health care systems improving the quality of their health care through sharing and learning from each other’s experiences and resources. It typically involves a number of hospitals working towards improving a similar, pre-determined area/s of care, over a set amount of time. Representatives from each hospital will meet and discuss their experiences, the strategies they used and share resources related to their efforts in improving the pre-determined area of care. The Breakthrough Series Approach has not been previously adapted such that consumers play a central role in guiding the process of change. This study will adapt the current Breakthrough Series Model to incorporate consumer involvement in identifying priority quality of care concerns, developing solutions and monitoring the success of those solutions. The theoretical underpinnings of the original Breakthrough Series Model will provide the basis of this intervention.

A modified Breakthrough Series approach will be used to deliver a multi­faceted consumer driven intervention aimed at improving patient­-centred care. This iterative and collaborative process will involve multi­disciplinary teams led by a Cancer Council New South Wales (CCNSW) consumer advocate. The teams will identify and work towards achieving hospital set goals, based on key patient priorities identified in the baseline data (Consumer Preferences Survey). The intervention will be carried out in a collaborative manner using the expertise and support of the multidisciplinary teams, the CCNSW, and change champions’. The intervention will occur as follows: 1) Selection of influential consumer advocates to lead change in each experimental hospital. 2) Pre-intervention workshop. 3) Hospital data and goal setting. A collaborative sub-committee will be established to provide support and higher-level advocacy to each hospital and monitor adherence to the intervention via monthly teleconferences.

The intervention will be conducted as a stepped wedge cluster randomised controlled trial with 6 sites. The 6 sites will be paired based on approximate size and location (rural/urban) of the hospital. All 6 units will start in the control condition. One site from each of the pairs (i.e. 3 of the 6 sites) will be randomly selected to switch to the intervention condition at 2 months after the commencement of baseline data collection, and will remain in the intervention condition for the remainder of the study intervention period (i.e. 10 month intervention). The remaining three chemotherapy units will switch to the intervention condition at 8 months after the commencement of baseline data collection, and will remain in the intervention condition for the remainder of the study intervention period (i.e. 4 month intervention). In total there will be 6 measurement periods.
Intervention code [1] 288419 0
Treatment: Other
Comparator / control treatment
A stepped wedge cluster randomised controlled trial will be used. In a stepped wedge cluster randomised controlled trial the intervention is introduced at different points in time and a functional relationship is demonstrated if the behavior changes only when the intervention is introduced.

An active comparator group will be used, where outcome data collected from patients after the introduction of the intervention will be compared to baseline data collected from patients prior to the implementation of the intervention.
Control group
Active

Outcomes
Primary outcome [1] 291055 0
Supportive care needs survey short form (SCNS-SF34) will be the primary outcome measure. The SCNS-SF34 is a 34 item measure, which assesses the perceived needs of people diagnosed with cancer.
Timepoint [1] 291055 0
Baseline and evaluation data from the SCNS-SF34 will be collected from patients at 3 collection time points consisting of 6 measurement periods in total. Baseline data collection will be made up of two measurement periods of which each will consist of data being collected during two weeks of the month. The first evaluation data collection point will be made up of two measurement periods, the first of which will occur 6 months post study commencement, and the second 7 months post study commencement. The second evaluation data collection point will be made up of two measurement periods, the first of which will occur 12 months post study commencement, and the second 13 months post study commencement.
Primary outcome [2] 291057 0
Quality of life will be measured using the Functional Assessment of Cancer Therapy – FACT-G. This is a 27-item questionnaire developed to assess QOL in people with cancer.
Timepoint [2] 291057 0
Baseline and evaluation data from the FACT-G will be collected from patients at 6 measurement periods. Baseline data collection will be made up of two measurement periods of which each will consist of data being collected during two weeks of the month. The first evaluation data collection point will be made up of two measurement periods, the first of which will occur 6 months post study commencement, and the second 7 months post study commencement. The second evaluation data collection point will be made up of two measurement periods, the first of which will occur 12 months post study commencement, and the second 13 months post study commencement.
Secondary outcome [1] 305901 0
The Consumer Preferences Survey contains three interactive exercises, which respondents are asked to complete:
i. Selecting general service initiatives: Participants select general service initiatives that they perceive would greatly improve their personal experience within the outpatient clinic.
ii. Selecting specific service initiatives: If a general initiative is selected, the survey displays a subsequent list of specific health service initiatives.
iii. Prioritizing general service initiatives: Participants who select at least two general service initiatives are directed to a modified relative prioritization exercise, where they are asked to prioritize those general service initiatives they had previously selected as being perceived as being able to greatly improve their personal experience within the outpatient clinic

The Consumer Preferences Survey provides a highly detailed list of potential health service initiatives. Data from the Consumer Preference Survey will be used by the consumer action group to identify and prioritize the areas of care that patients would like to be improved, and to develop and implement strategies to improve these identified areas of care.
Timepoint [1] 305901 0
Baseline and evaluation data from the Consumer Preference Survey will be collected from patients at 6 measurement periods. Baseline data collection will be made up of two measurement periods of which each will consist of data being collected during two weeks of the month. The first evaluation data collection point will be made up of two measurement periods, the first of which will occur 6 months post study commencement, and the second 7 months post study commencement. The second evaluation data collection point will be made up of two measurement periods, the first of which will occur 12 months post study commencement, and the second 13 months post study commencement.

As part of the intervention, data will be collected on an ongoing basis using the Consumer Preference Survey and fed back to the Consumer Action Group to guide them in making changes to patient care based on patient feedback. This data collected as part of the intervention strategy will be collected on a monthly basis.

Eligibility
Key inclusion criteria
Eligible hospitals will be New South Wales based chemotherapy units.

Patients will be eligible if they are 18 years or over; receiving chemotherapy for a current cancer diagnosis as an outpatient; have attended the hospital on at least one previous occasion for cancer treatment; can read and write English and provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they: Are attending the clinic for the first time; Are judged by clinic staff to be too unwell to complete the survey; have an intellectual or mental impairment; or are under the age of 18 years.

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)
A stepped wedge cluster randomised controlled trial with six medical oncology treatment centres will be used to examine the effectiveness of the intervention. The 6 sites will be paired based on approximate size and location (rural/urban) of the hospital. All 6 units will start in the control condition. One site from each of the pairs (i.e. 3 of the 6 sites) will be randomly selected via a computer-generated sequence to switch to the intervention condition at 2 months after the commencement of baseline data collection. The remaining three chemotherapy units will switch to the intervention condition at 8 months after the commencement of baseline data collection. In total there will be 6 measurement periods. The intervention is introduced at different points in time and a functional relationship is demonstrated if the behavior changes only when the intervention is introduced. All hospitals taking part in this study will receive the intervention. Allocation is not concealed.

Upon checking in for their appointment, a trained Cancer Council NSW volunteer will approach patients in the outpatient clinic or treatment area and introduce themselves, determine eligibility, provide a verbal summary of the study aims (in accordance with the study information statement), and provide the patient with a copy of a written information statement. Recruitment may occur within the out-patient clinic waiting rooms or within the open-area treatment spaces where patients may be receiving intravenous treatment. The volunteer will advise potential participants that participation is voluntary and that their decision to participate will not affect their medical care in any way. They will also be informed that they can pause or end the survey at any time without providing a reason. Study information, including risks and benefits of voluntary participation, will be readily available within the clinics. This includes the Participant Brochure that will be available in the clinic, and a one-page Information Poster displayed prominently within clinic waiting rooms and treatment areas.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Chemotherapy units will be matched on approximate size (number of patients seen each year) and location (urban/rural). One unit from each pair will be randomly allocated to the experimental group and one to the control group using a computer generated procedure.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The assignment of the cluster units used in this study would be classified as stepped wedge. This is where all units begin in the control condition and finish in the intervention condition and the intervention is introduced to different units at different times.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Assuming an intra-cluster correlation coefficient (ICC) of 0.2, 27 subjects per cluster per measurement period will provide the study with 80% power to detect a difference between treatment groups of 0.4 standard deviations at the 2.5% significance level. This corresponds to a 10.1 unit difference on the SCNS-SF34 and a 6 unit difference in the FACT-G total score. Additional data will be collected from up to 300 participants per site to feedback to the consumer action group to allow them to monitor the progress of their intervention strategies. This sample size was determined using the method of Hussey and Hughes, assuming an intraclass correlation of 0.03, and corresponds to approximately 27 subjects per-site per measurement period.

A linear regression model will be used to assess the effect of the intervention. The two primary outcome variables will be unmet needs and quality of life. A fixed effect for treatment centre will be included, which accounts for differences in the average level of the outcome across centres and the association between before/after and centre induced by the stepped-wedge design. The main predictor of interest will be a before/after intervention variable, which would be at a different time point for each centre and will measure the intervention effect, which after adjusting for centre is a weighted average of the effect within each centre. Time (from baseline in months) will be included in the model as a continuous measure to account for any secular trends.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1899 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 1900 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [3] 1901 0
Armidale Rural Referral Hospital - Armidale
Recruitment hospital [4] 2056 0
Gosford Hospital - Gosford
Recruitment postcode(s) [1] 7672 0
2298 - Waratah
Recruitment postcode(s) [2] 7673 0
2350 - Armidale
Recruitment postcode(s) [3] 7676 0
2340 - North Tamworth
Recruitment postcode(s) [4] 7746 0
2250 - Gosford

Funding & Sponsors
Funding source category [1] 288406 0
Government body
Name [1] 288406 0
Australian Research Council
Address [1] 288406 0
Level 2, 11 Lancaster Place
Majura Park ACT 2609
AUSTRALIA
Country [1] 288406 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University of Newcastle
University Drive
Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 287105 0
Charities/Societies/Foundations
Name [1] 287105 0
Cancer Council New South Wales
Address [1] 287105 0
PO BOX 572
Kings Cross, NSW 2011
Country [1] 287105 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290284 0
Hunter New England HREC
Ethics committee address [1] 290284 0
Research Ethics and Governance Unit
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 290284 0
Australia
Date submitted for ethics approval [1] 290284 0
Approval date [1] 290284 0
21/11/2013
Ethics approval number [1] 290284 0
13/08/21/4.07

Summary
Brief summary
The aim of the study is to assess the effectiveness of a consumer driven breakthrough action model in improving aspects of cancer treatment systems.

Who is it for?
You may be eligible to join this study if you are aged 18 years or more and are receiving chemotherapy for a current cancer diagnosis as an outpatient at one of the participating NSW based hospitals.

Study details
This study is trialling a consumer action model which aims to improve aspects of cancer treatment systems which have been identified as priorities by chemotherapy cancer patients. Hospitals involved in this study will participate in a quality improvement intervention, based on the Breakthrough Series. The Breakthrough Series is a collaborative model of learning developed by the Institute for Healthcare Improvement (IHI). This model focuses on health care systems improving the quality of their health care through sharing and learning from each other’s experiences and resources. This study will adapt the current Breakthrough Series Model to incorporate consumer involvement in identifying priority quality of care concerns, developing solutions and monitoring the success of those solutions. Participants will be asked to complete questionnaires throughout the study in order to evaluate the degree of unmet supportive care needs and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44782 0
Prof Rob Sanson-Fisher
Address 44782 0
Public Health /HBRG
W4, HMRI Building
University of Newcastle
University Drive
Callaghan NSW 2308
Country 44782 0
Australia
Phone 44782 0
+61 2 4042 0713
Fax 44782 0
Email 44782 0
Rob.Sanson-Fisher@newcastle.edu.au
Contact person for public queries
Name 44783 0
Miss Alix Hall
Address 44783 0
Public Health /HBRG
W4, HMRI Building
University of Newcastle
University Drive
Callaghan NSW 2308
Country 44783 0
Australia
Phone 44783 0
+61 2 4042 0641
Fax 44783 0
Email 44783 0
Alix.Hall@newcastle.edu.au
Contact person for scientific queries
Name 44784 0
Miss Alix Hall
Address 44784 0
Public Health /HBRG
W4, HMRI Building
University of Newcastle
University Drive
Callaghan NSW 2308
Country 44784 0
Australia
Phone 44784 0
+61 2 4042 0641
Fax 44784 0
Email 44784 0
Alix.Hall@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary