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
ACTRN12613000276752
Ethics application status
Approved
Date submitted
17/02/2013
Date registered
7/03/2013
Date last updated
20/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study to evaluate the incidence and nature of unplanned medical visits for patients with early breast cancer during the course of their management following surgery: PATIPS-A
Scientific title
Pilot study to evaluate the incidence and nature of unplanned medical visits for patients with early breast cancer during the course of their management following surgery: PATIPS-A
Secondary ID [1] 281975 0
None
Universal Trial Number (UTN)
Trial acronym
PATIPS-A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 288403 0
Condition category
Condition code
Cancer 288751 288751 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We are aiming to collect details of the side effects that you experience during each phase of your treatment, how often and the reason that you see your GP or specialist during your breast cancer treatment for unexpected medical problems; and what treatment is given to you for these medical problems.
The information will be collected in a patient self-reported diary and sourced in routine medical practice medical file notes. Paticipants will be observed until completion of their designated treatments - this will range from 2 to 6 months depending on which treatments the participant undergoes.
Intervention code [1] 286546 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288892 0
The nature and frequency of adverse events related to surgery, chemotherapy and/or radiation therapy in patients with early breast cancer.
Typical adverse events would include seroma, wound infection, moist desquamation, neutropenic sepsis. This will be assessed by the patient self report diary.
Timepoint [1] 288892 0
End of study assessment.
Secondary outcome [1] 301250 0
First point of medical contact for management of adverse event
Assessed by patient self report diary and routine medical file notes
Timepoint [1] 301250 0
End of Study
Secondary outcome [2] 301620 0
Treatment recommended for adverse event
Assessed by patient self report diary and routine medical file notes
Timepoint [2] 301620 0
End of study
Secondary outcome [3] 301621 0
Adverse event outcome
Assessed by patient self report diary and routine medical file notes
Timepoint [3] 301621 0
End of study
Secondary outcome [4] 301622 0
Rates and reason for hospitalisation
Assessed by patient self report diary and routine medical file notes
Timepoint [4] 301622 0
End of study

Eligibility
Key inclusion criteria
i. Patient consent
ii. Consecutive patients who will be receiving radiation therapy and/or who will receive chemotherapy.
iii. English is the first language
iv. Residential address in the Perth greater metropolitan area
v. Regular GP as defined by the patient or no regular GP available. (GP consent is not considered necessary as SP and GP have recognised joint responsibility for the patient and if the patient consents to study, it is implied that communications between the GP and SP is freely provided)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Patient not to receive either chemotherapy or radiation therapy

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

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)
WA
Recruitment postcode(s) [1] 6354 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 286752 0
Charities/Societies/Foundations
Name [1] 286752 0
Breast Cancer Research Centre - WA
Address [1] 286752 0
146 Mounts Bay Rd
Perth WA
6000
Country [1] 286752 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Breast Cancer Research Centre - WA
Address
146 Mounts Bay Rd
Perth WA
6000
Country
Australia
Secondary sponsor category [1] 285532 0
None
Name [1] 285532 0
Address [1] 285532 0
Country [1] 285532 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288821 0
Mount Hospital
Ethics committee address [1] 288821 0
150 Mounts Bay Rd Perth WA 6000
Ethics committee country [1] 288821 0
Australia
Date submitted for ethics approval [1] 288821 0
07/01/2013
Approval date [1] 288821 0
05/02/2013
Ethics approval number [1] 288821 0
EC73.2

Summary
Brief summary
Survival from breast cancer has improved significantly over the past 30 years. This has been due to the coordinated approach of surgery, chemotherapy and/or radiation therapy with each member of your treating specialist team contributing to your treatment recommendation. For each of these three disciplines of treatment, the conduct of clinical research has led to more effective ways of performing surgery and delivery of the best drug combinations and radiation therapy. In addition, research has also aimed to reduce side effects and therefore make each of these treatment approaches, safer and less intrusive to the quality of your life.

However, it is still likely that patients will experience side effects of some kind as a result of their surgery, chemotherapy and/or radiation therapy. Currently, it is not known how often the specialist treating team or the patient’s general practitioner is managing these side effects; and how successful the treatment recommended is. Understanding the frequency of side effects that lead to an unplanned visit with a member of your specialist treating team or GP and how these side effects are managed, will allow us to plan more effective ways of coordinating the care, to ultimately improve the well-being of breast cancer patients as they undergo the various stages of their breast cancer treatment.
Trial website
bcrc-wa.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37934 0
Prof Arlene Chan
Address 37934 0
41/146 Mounts Bay Rd
WA Perth 6000
Country 37934 0
Australia
Phone 37934 0
+61 8 94814522
Fax 37934 0
+61 8 94814544
Email 37934 0
admin.profachan@me.com
Contact person for public queries
Name 37935 0
Prof Arlene Chan
Address 37935 0
41/146 Mounts Bay Rd
Perth WA 6000
Country 37935 0
Australia
Phone 37935 0
+61 8 94814522
Fax 37935 0
+61 8 94814544
Email 37935 0
admin.profachan@me.com
Contact person for scientific queries
Name 37936 0
Prof Arlene Chan
Address 37936 0
41/146 Mounts Bay Rd
Perth WA 6000
Country 37936 0
Australia
Phone 37936 0
+61 8 94814522
Fax 37936 0
+61 8 94814544
Email 37936 0
admin.profachan@me.com

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