Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000482763
Ethics application status
Approved
Date submitted
2/03/2022
Date registered
28/03/2022
Date last updated
28/03/2022
Date data sharing statement initially provided
28/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
PACE: Psychosocial Aspects of Choice in Early Breast Cancer Treatment
Scientific title
PACE: Psychosocial Aspects of Choice in Early Breast Cancer Treatment
Secondary ID [1] 306555 0
BCRC-WA133
Universal Trial Number (UTN)
Trial acronym
PACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Breast Cancer 325450 0
Condition category
Condition code
Cancer 322830 322830 0 0
Breast
Mental Health 322941 322941 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with Early Breast Cancer who have been recommended for further treatment, either chemotherapy, endocrine therapy or combination, will be asked to participate. Patients will be asked whether they intend to comply with the recommendation of their treating clinician. Patients will also be asked to complete a range of questionnaires at baseline as well as provide demographic information (age, ethnicity, education level, employment status). Questionnaires include:
Beliefs about medicine questionnaire (BMQ - General, BMQ - endocrine specific, BMQ-chemotherapy specific as applicable), Hospital Anxiety and Depression Scale (HADS), use of Complementary and Alternative Medicines (CAMs), fear of treatment, negative experiences (self and friends/family).
Patients will then be followed for 5 years with a brief, 5-question survey (Medical Adherence Report Scale MARS-5 - at 3 monthly intervals for 2 years, then 6 monthly up to 5 years) to assess self-reported compliance to ongoing treatment. Patient records will be reviewed for clinician-reported compliance and and breast cancer recurrence events
Intervention code [1] 322987 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330856 0
Incidence of non-initiation and early cessation of conventional cancer treatment as determined by study-specific questionnaires
Timepoint [1] 330856 0
Baseline, then every three months for two years followed by every 6 months to a total of five years
Secondary outcome [1] 406974 0
To identify prevalence of patients who do not comply with recommendations for Conventional Cancer Treatment who have a belief in Complementary and Alternative Medicines as determined by study-specific questionnaire
Timepoint [1] 406974 0
baseline
Secondary outcome [2] 407271 0
To identify psychological and demographic factor, including reasons for use of Complementary and Alternative Medicines which impact on non-compliance of recommendations for Conventional Cancer Treatment using study-specific questionnaires
Timepoint [2] 407271 0
baseline
Secondary outcome [3] 407272 0
To identify rates of breast cancer recurrence in the follow-up period via review of medical records
Timepoint [3] 407272 0
Three monthly for two years then six monthly for a total of five years

Eligibility
Key inclusion criteria
a) Written consent to participate.
b) Female or male aged over 18 years with early-stage breast cancer (stages 0
to III). Patients with unilateral or bilateral breast cancer are eligible.
c) Recommended for systemic neoadjuvant (N) and/or adjuvant (A) treatment by
member of PBCI.
d) Planned to continue their care with a clinician at PBCI following initiation of
adjuvant systemic treatment.
e) Patient regards themselves as fluent in English
f) Patients with an earlier history of breast cancer are eligible, as long as they
are considered disease-free from the first BC diagnosis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Prior history of another malignancy for which the patient is not considered
cured
b) Systemic treatment recommendations and administration is outside the PBCI
c) Medical indication is identified during the period of pre-systemic treatment
commencement which alters the MO’s systemic treatment recommendation
on a risk vs. benefit balance leading to a recommendation to not receive
systemic treatment

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Prevalence statistics for non-initiation and non-adherence with CCT will be recorded.
BMQ score will be totalled and its median score will be reported by patient initiation and early cessation of CCT. Differences in the total BMQ score and its subscales between patients who initiated and did not initiate CCT, as well as patients who ceased CCT early and did not will be assessed using Kruskal-Wallis tests.
Correlation between BMQ score (including its subscales) and CCT adherence score will be assessed using multiple linear regression, adjusted for patient characteristics,
HADS score and other potential confounders. In the event of small numbers across
the 5 levels of BMQ and compliance, the outcome measures will be recoded into binary outcome variables. The differences in the BMQ score (and its subscales) will then be compared using independent samples t-tests. Associations between patient variables and the binary outcome variables will be assessed using logistic regression models. Association between use of CAMS and non-compliance with CCT will also be assessed as described above. Association between non-compliance of CCT and breast cancer event will be assessed using logistic regression model adjusted for patient variables.
To assess for a correlation between perceived harm from recommended treatment as it impacts on compliance with recommended treatment, a total of 90 patients (45 per group) is needed to detect a difference of 4 points with a standard deviation of 5.9 points with 90% power and 5% alpha.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/03/2022
Date of last participant enrolment
Anticipated
7/03/2024
Actual
Date of last data collection
Anticipated
7/03/2029
Actual
Sample size
Target
400
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21851 0
Breast Cancer Research Centre - Western Australia - Perth

Funding & Sponsors
Funding source category [1] 310889 0
Charities/Societies/Foundations
Name [1] 310889 0
Breast Cancer Research Centre - WA
Country [1] 310889 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Breast Cancer Research Centre - WA
Address
Suite 407, Level 4
91 Monash Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 312166 0
None
Name [1] 312166 0
Address [1] 312166 0
Country [1] 312166 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310449 0
Ramsay Health Care SA/WA HREC
Ethics committee address [1] 310449 0
Ethics committee country [1] 310449 0
Australia
Date submitted for ethics approval [1] 310449 0
28/09/2021
Approval date [1] 310449 0
15/11/2021
Ethics approval number [1] 310449 0
2145W

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

Contacts
Principal investigator
Name 117710 0
Prof Arlene Chan
Address 117710 0
Breast Cancer Research Centre - WA
Suite 406, Level 4
91 Monash Ave
Nedlands WA 6009
Country 117710 0
Australia
Phone 117710 0
+6189481 4522
Fax 117710 0
Email 117710 0
admin.profchan@me.com
Contact person for public queries
Name 117711 0
Linda Armstrong
Address 117711 0
Breast Cancer Research Centre - WA
Suite 407, Level 4
91 Monash Ave
Nedlands WA 6009
Country 117711 0
Australia
Phone 117711 0
+61 08 6500 5501
Fax 117711 0
Email 117711 0
linda.armstrong@bcrc-wa.com.au
Contact person for scientific queries
Name 117712 0
Arlene Chan
Address 117712 0
Breast Cancer Research Centre - WA
Suite 406, Level 4
91 Monash Ave
Nedlands WA 6009
Country 117712 0
Australia
Phone 117712 0
+61894814522
Fax 117712 0
Email 117712 0
admin.profchan@me.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Requests from external source for deidentified data for inclusion in other appropriate similar research will be on a case to case basis and final decision to release data will be made by the PI
When will data be available (start and end dates)?
Fulfilling the above criteria after completion of study and publication of primary results (start date) until 5 years from publication (end date)
Available to whom?
Legitimate researchers involved in appropriate similar research, as approved on a case by case basis by PI
Available for what types of analyses?
Similar appropriate research as deemed appropriate by PI
How or where can data be obtained?
Contact via www.bcrc-wa.com.au


What supporting documents are/will be available?

No Supporting Document Provided



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.