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Trial registered on ANZCTR


Registration number
ACTRN12618000243213
Ethics application status
Approved
Date submitted
22/01/2018
Date registered
14/02/2018
Date last updated
7/01/2020
Date data sharing statement initially provided
11/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Identifying prevalence and nature of physical and psychosocial symptoms in breast cancer survivors seen at a tertiary referral breast cancer centre
Scientific title
Identifying prevalence and nature of physical and psychosocial symptoms in breast cancer survivors seen at a tertiary referral breast cancer centre
Secondary ID [1] 293825 0
BCRC114
Universal Trial Number (UTN)
Trial acronym
Early Breast Cancer Socioeconomic and Psychological Impact (ESPI) study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosocial needs 306249 0
Physical needs 306250 0
Breast cancer 306401 0
Condition category
Condition code
Cancer 305349 305349 0 0
Breast
Public Health 305350 305350 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this study, any participant aged 18 years and above who has been diagnosed with early breast cancer, undergone breast surgery and completed their adjuvant treatment under the care of clinicians at Breast Cancer Research Centre-WA will be asked to complete a questionnaire of 192 questions. It will assess the prevalence and magnitude of physical and psychosocial issues in breast cancer survivors.

All participants will complete the following questionnaires/surveys to evaluate:
a. Demographics and socioeconomic information via a modified survey based on the Australia Bureau of Statistic Forms of Employment survey
b. Mood disturbances: PHQ-9 & GAD-7
c. Quality of life based on prior adjuvant treatment received: Fact-B
d. Cognitive functioning: Fact-Cog
e. Impact of spirituality: Facit-Sp-12
f. Financial impact: Cost – FACIT
g. Fatigue: Facit-F
In addition, participants who have received taxane based chemotherapy, endocrine therapy or both will also complete the following quality of life questionnaires, as relevant:
h. Taxane based chemotherapy: FACT-Taxane
i. Endocrine treatment: FACT-ES

Participants sign a consent form to confirm in writing they agree to take part in the study. Upon return of signed PIC, delegated BCRC-WA staff will review eligibility and confirm final eligibility with the PI. Study staff will then obtain demographic information about the participant.

Then participants will be asked to complete the questionnaires at home within 42 days of signing consent. It is anticipated that this will take them 15-30 minutes overall. Participants will be emailed their unique survey code ID with a link to the SurveyMonkey questionnaires.
Intervention code [1] 300082 0
Not applicable
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304500 0
To assess the prevalence of physical issues (fatigue) in breast cancer survivors occurring at five time points in a group of patients with early breast cancer treated by a multidisciplinary breast cancer team in Western Australia. This will be assessed using a questionnaire designed specifically for this study.
Timepoint [1] 304500 0
The timepoint at which the above study outcome will be assessed is once the overall target number of participants have completed the questionnaires.

The study considers a "timepoint" to be the number of years post which the participant completed treatment for breast cancer. Participants who completed treatment one year prior will be considered to be at "timepoint 1". Participants who completed treatment two years prior will be considered to be at "timepoint 2", etc up to "timepoint 5" or 5 years post treatment.
Each recruited study participant will only complete questionnaires on one occasion.
Primary outcome [2] 304636 0
To assess the magnitude of physical issues (fatigue) in breast cancer survivors occurring at five time points in a group of patients with early breast cancer treated by a multidisciplinary breast cancer team in Western Australia. This will be assessed using a questionnaire designed specifically for this study.
Timepoint [2] 304636 0
The timepoint at which the above study outcome will be assessed is once the overall target number of participants have completed the questionnaires.

The study considers a "timepoint" to be the number of years post which the participant completed treatment for breast cancer. Participants who completed treatment one year prior will be considered to be at "timepoint 1". Participants who completed treatment two years prior will be considered to be at "timepoint 2", etc up to "timepoint 5" or 5 years post treatment.
Each recruited study participant will only complete questionnaires on one occasion.
Primary outcome [3] 304637 0
To assess the prevalence and magnitude of psychosocial issues in breast cancer survivors (cognitive functioning, employment & financial status, mood disturbance and social needs) occurring at five time points in a group of patients with early breast cancer treated by a multidisciplinary breast cancer team in Western Australia. This will be assessed using a questionnaire designed specifically for this study.
Timepoint [3] 304637 0
The timepoint at which the above study outcome will be assessed is once the overall target number of participants have completed the questionnaires.

The study considers a "timepoint" to be the number of years post which the participant completed treatment for breast cancer. Participants who completed treatment one year prior will be considered to be at "timepoint 1". Participants who completed treatment two years prior will be considered to be at "timepoint 2", etc up to "timepoint 5" or 5 years post treatment.
Each recruited study participant will only complete questionnaires on one occasion.
Secondary outcome [1] 342160 0
To assess which patient characteristics (demographics, socioeconomic and pre-morbid health issues) may be more likely to be associated with the occurrence of specific survivorship problems (fatigue and physical function, pain, sexual function, cognitive function, employment, finance and return to work, emotional distress, depression, anxiety and social needs). This will be assessed using a questionnaire designed specifically for this study.
Timepoint [1] 342160 0
At completion of the questionnaire.
Secondary outcome [2] 342163 0
To assess which psychosocial demographics may be more likely to be associated with the occurrence of specific survivorship problems (fatigue and physical function, pain, sexual function, cognitive function, employment, finance and return to work, emotional distress, depression, anxiety and social needs). Psychosocial demographics includes those who report symptoms of mood disturbance on PHQ-9 and GAD-7, and social demographics captured on the ABSFE such as lives alone, employment or financial difficulties. This will be assessed using a questionnaire designed specifically for this study.
Timepoint [2] 342163 0
At completion of the questionnaire.
Secondary outcome [3] 342165 0
To assess differences in survivorship issues (fatigue and physical function, pain, sexual function, cognitive function, employment, finance and return to work, emotional distress, depression, anxiety and social needs) between patients who receive taxane chemotherapy only, non-taxane based chemotherapy and endocrine treatment, endocrine treatment only and no systemic treatment. This will be assessed using a questionnaire designed specifically for this study.
Timepoint [3] 342165 0
At completion of the questionnaire.

Eligibility
Key inclusion criteria
1. Provision of written informed consent
2. At least 18 years of age at the time of consent
3. Diagnosis of early (non-metastatic) breast cancer. This includes patients diagnosed with DCIS only, provided they have undergone surgery.
4. Have undergone definitive breast surgery
5. Have completed recommended chemotherapy with or without trastuzumab treatment and/or targeted radiation therapy as part of their adjuvant treatment (patients who did not complete planned treatment as a consequence of intolerable toxicity and/or at the recommendation of the treating breast specialist remain eligible for inclusion). Patients for whom no chemotherapy was recommended are also eligible.
6. Patients must have received their surgical, systemic and/or radiation treatment under the care of a doctor at BCRC-WA
7. Patients who were diagnosed with any psychological disorder prior to or following breast cancer diagnosis are eligible
8. Clinically assessed as disease-free by the treating clinician at the time of study consent
9. Commits to completing all questionnaires online within 42 days of consent. This is estimated to take up to 30 minutes, which does not need to be done at one time point.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who do not regard Western Australia as their state of residence.
2. Patients who work and live outside Western Australia > 6 months of the year.
3. Patients who are unable to read and understand English
4. Patients who have declined part or all recommended breast cancer treatment against medical advice.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Hypothesis
It is estimated that >30% of early breast cancer patients who have received systemic adjuvant treatment will experience survivorship issues in the subsequent 5 years following diagnosis. During this period, it may affect physical and psychosocial functioning with changes to their employment and/or financial status, and the severity and incidence will diminish over time.

Study time-points
The study will be broken down into 5 patient cohorts. The cohorts will comprise of patients who are disease-free at 1 year, 2 years, 3 years, 4 years and 5 years from the date of diagnosis (defined as the date of definitive surgery). Each participant will be required to complete the assigned study questionnaires within 42 days of signing the consent form. A window period of ± 3 months will apply for purposes of recruitment at each of these time points.

All participants will complete the following questionnaires/surveys to evaluate:
a. Demographics and socioeconomic information via a modified survey based on the Australia Bureau of Statistic Forms of Employment survey
b. Mood disturbances: PHQ-9 & GAD-7
c. Quality of life based on prior adjuvant treatment received: Fact-B
d. Cognitive functioning: Fact-Cog
e. Impact of spirituality: Facit-Sp-12
f. Financial impact: Cost – FACIT
g. Fatigue: Facit-F

In addition, participants who have received taxane based chemotherapy, endocrine therapy or both will also complete the following quality of life questionnaires, as relevant:
h. Taxane based chemotherapy: FACT-Taxane
i. Endocrine treatment: FACT-ES

Analytical method
The analysis will be descriptive in nature. Upon identifying the most prevalent physical and psychosocial issues at each time point, an exploratory analysis of association between patient and treatment characteristics will be made.

Sample Size
To estimate the prevalence of common physical and psychosocial conditions for each time point with a standard error of 5%, a minimum of 40 participants for each time point are required. To this end, allowing for participant dropout of approximately 10%, recruitment will aim for 45 participants at each of the study time points (i.e. year 1,2,3,4 or 5 after diagnosis).

Recruitment
Recruitment status
Recruiting
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)
WA

Funding & Sponsors
Funding source category [1] 298439 0
Charities/Societies/Foundations
Name [1] 298439 0
Breast Cancer Research Centre-WA
Address [1] 298439 0
Hollywood Private Hospital Entrance 3, Lower Ground floor 101 Monash Ave, Nedlands, Perth. W.A. 6009
Country [1] 298439 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Breast Cancer Research Centre-WA
Address
Hollywood Private Hospital
Entrance 3, Lower Ground floor
101 Monash Ave, Nedlands, Perth. W.A. 6009
Country
Australia
Secondary sponsor category [1] 297583 0
None
Name [1] 297583 0
Address [1] 297583 0
Country [1] 297583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299434 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [1] 299434 0
Hollywood Private Hospital Locked Bag 2002, Nedlands Perth WA 6909
Ethics committee country [1] 299434 0
Australia
Date submitted for ethics approval [1] 299434 0
18/01/2018
Approval date [1] 299434 0
29/03/2018
Ethics approval number [1] 299434 0

Summary
Brief summary
Hypothesis
It is estimated that >30% of early breast cancer patients who have received systemic adjuvant treatment will experience survivorship issues in the subsequent 5 years following diagnosis. During this period, it may affect physical and psychosocial functioning, with changes to their employment and/or financial status, and the severity and incidence will diminish over time.

Aim
The aim is to identify how a prior diagnosis of breast cancer and its treatment impacts on physical and psychosocial functioning over time. For this trial, no study specific visit at the clinic is required.

Who is it for?
In this trial, any participant aged 18 years and above who has been diagnosed with early breast cancer, undergone breast surgery and completed their adjuvant treatment under the care of clinicians at Breast Cancer Research Centre-WA will be asked to complete a questionnaire of 192 questions. It will assess the prevalence and magnitude of physical and psychosocial issues in breast cancer survivors. In addition, some demographic information will be collected.

Study details
Upon return of signed Participant PICF a delegated BCRC-WA trial staff and PI will review eligibility. The Participant will be emailed their unique survey code ID with a link to the SurveyMonkey questionnaire to complete within 42 days of the consent signature. It is anticipated that this will take them 15-30 minutes overall.

The trial data collected will only be analysed after recruitment is complete and all data has been collected. It is clearly stated in the Patient Informed Consent that data is not collected for treatment purpose.

The trial recruitment period is planned to last 6-12 months, the expected duration of the project is January 2018 to January 2020. It is anticipated that 200 participants will be recruited.
Trial website
http://bcrc-wa.com.au/our-research/current-trials/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80390 0
Prof Arlene Chan
Address 80390 0
Hollywood Private Hospital, Entrance 3, Lower Ground Floor, 101 Monash Ave, Nedlands 6009 Western Australia
Country 80390 0
Australia
Phone 80390 0
+61 8 94814522
Fax 80390 0
Email 80390 0
bctu@bcrc-wa.com.au
Contact person for public queries
Name 80391 0
Mrs Karen Shakespeare
Address 80391 0
Hollywood Private Hospital, Entrance 3, Lower Ground Floor, 101 Monash Ave, Nedlands 6009 Western Australia
Country 80391 0
Australia
Phone 80391 0
+61 8 65005555
Fax 80391 0
Email 80391 0
bctu@bcrc-wa.com.au
Contact person for scientific queries
Name 80392 0
Prof Arlene Chan
Address 80392 0
Hollywood Private Hospital, Entrance 3, Lower Ground Floor, 101 Monash Ave, Nedlands 6009 Western Australia
Country 80392 0
Australia
Phone 80392 0
+61 8 94814522
Fax 80392 0
Email 80392 0
bctu@bcrc-wa.com.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?
Data will only be shared amongst participating investigators as pertains to the study endpoints and specified analyses
When will data be available (start and end dates)?
At time of data clean and first data analysis and up until time of final publication
Available to whom?
participating investigators
Available for what types of analyses?
Analyses as planned per protocol, or as exploratory analyses based on study findings which may serve as rationale for further clinical research evaluation
How or where can data be obtained?
Data fields from primary study database will be shared as deidentified records in Excel spreadsheet
What supporting documents are/will be available?
No other documents available
Summary results
No Results