Trial registered on ANZCTR


Trial ID
ACTRN12611001000998
Ethics application status
Approved
Date submitted
13/09/2011
Date registered
20/09/2011
Date last updated
25/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Meeting the education and support needs of women with breast cancer who are referred for radiotherapy: A multiple-baseline study
Scientific title
The effect of a tailored educational intervention package (RT Prepare) on psychological distress levels in women with breast cancer who are referred for radiotherapy
Secondary ID [1] 262963 0
APP1006458 Cancer Australia
Universal Trial Number (UTN)
Trial acronym
RT Prepare
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women diagnosed with breast cancer 270686 0
Condition category
Condition code
Cancer 270860 270860 0 0
Breast
Mental Health 270996 270996 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The tailored educational intervention package consists of: 1) a one-on-one consultation with a radiation therapist prior to treatment planning and 2) a one-on-one consultation with radiation therapist prior to first treatment. Prior to the introduction of this intervention, communication and consultation skills training will be provided to radiation therapists and they will be educated about what information to provide to patients at each time point. During the one to one consultations the radiation therapist will meet the patient for 20 minutes to discuss the procedure that is about to occur, what will be expected of the patient, any immediate discomfort or pain they should anticipate and any short or long term side efects that may result form the procedure.
Intervention code [1] 269303 0
Treatment: Other
Comparator / control treatment
Usual care patients - Patients will be provided with the standard information that departments routinely provide at radiation planning and treatment.
Control group
Active

Outcomes
Primary outcome [1] 279617 0
Psychological distress measured using the Hospital Anxiety and Depression Scale.
Timepoint [1] 279617 0
1) First appointment with their radiation oncologist
2) Following one on one consultation with a radiation therapist prior to treatment planning
3) Following one on one consultation with a radiation therapiston the first day of treatment.
4) Treatment completion.
Secondary outcome [1] 287868 0
Specific concerns about radiotherapy measured by the Concerns about RT scale Short Form Health Survey
Timepoint [1] 287868 0
1) First appointment with their radiation oncologist
2) Following one on one consultation with a radiation therapist prior to treatment planning
3) Following one on one consultation with a radiation therapiston the first day of treatment.
4) Treatment completion.
Secondary outcome [2] 294041 0
patient knowledge of radiotherapy measured by the Knowledge of RT scale
Timepoint [2] 294041 0
1) First appointment with their radiation oncologist
2) Following one on one consultation with a radiation therapist prior to treatment planning
3) Following one on one consultation with a radiation therapiston the first day of treatment.
4) Treatment completion.
Secondary outcome [3] 294042 0
patient preparedness measured by the Cancer Treatment Survey
Timepoint [3] 294042 0
1) First appointment with their radiation oncologist
2) Following one on one consultation with a radiation therapist prior to treatment planning
3) Following one on one consultation with a radiation therapiston the first day of treatment.
4) Treatment completion.
Secondary outcome [4] 294043 0
Patient general health as measured by the Short Form Health Survey (SF-12).
Timepoint [4] 294043 0
1) First appointment with their radiation oncologist
2) Following one on one consultation with a radiation therapist prior to treatment planning
3) Following one on one consultation with a radiation therapiston the first day of treatment.
4) Treatment completion.

Eligibility
Key inclusion criteria
Participants will be eligible for the study if they have been diagnosed with breast cancer, are about to commence a course of radiation therapy that will be more than 4 weeks, are over the age of 18, do not have cognitive impairement or psychiatric illness and are able to converse freely in English.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have commenced treatment or completed treatment planning and who have cognitive impairments or psychiatric illness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
none
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
none
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Multiple Baseline Study-All sites will initially collect data from usual care patients. Recruitment sites will then be randomly assigned to commence the intervention arm at different time points.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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
Current
Final
Recruitment in Australia
Recruitment state(s)
VIC,SA,WA
Recruitment hospital [1] 1538 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 1539 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [3] 1540 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7380 0
6009 - Nedlands
Recruitment postcode(s) [2] 7381 0
3165 - Bentleigh East
Recruitment postcode(s) [3] 7382 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 269768 0
Government body
Name [1] 269768 0
Cancer Australia
Address [1] 269768 0
Locked Bag 3 STRAWBERRY HILLS NSW 2012
Country [1] 269768 0
Australia
Funding source category [2] 269891 0
Charities/Societies/Foundations
Name [2] 269891 0
Beyond Blue
Address [2] 269891 0
PO Box 6100
Hawthorn West, Victoria 3122
Country [2] 269891 0
Australia
Primary sponsor type
Government body
Name
Cancer Australia
Address
Locked Bag 3 STRAWBERRY HILLS NSW 2012
Country
Australia
Secondary sponsor category [1] 268809 0
None
Name [1] 268809 0
Address [1] 268809 0
Country [1] 268809 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271727 0
Sir Charles Gairdner Human Research Ethics Committee
Ethics committee address [1] 271727 0
Sir Charles Gairdner Hospital
Hospital Ave
NEDLANDS WA 6009
Ethics committee country [1] 271727 0
Australia
Date submitted for ethics approval [1] 271727 0
30/08/2011
Approval date [1] 271727 0
Ethics approval number [1] 271727 0
2011-130
Ethics committee name [2] 271861 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [2] 271861 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [2] 271861 0
Australia
Date submitted for ethics approval [2] 271861 0
30/08/2011
Approval date [2] 271861 0
Ethics approval number [2] 271861 0
Ethics committee name [3] 271862 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [3] 271862 0
Peter MacCallum Cancer Centre
Level 4, 10 St Andrews Place
East Melbourne, VIC 3002
Ethics committee country [3] 271862 0
Australia
Date submitted for ethics approval [3] 271862 0
15/10/2011
Approval date [3] 271862 0
Ethics approval number [3] 271862 0
Ethics committee name [4] 289963 0
Curtin University Human Research Ethics Committee
Ethics committee address [4] 289963 0
Office of Research and Development
Curtin University
GPO Box U 1987
Perth, Western Australia 6845
Ethics committee country [4] 289963 0
Australia
Date submitted for ethics approval [4] 289963 0
08/08/2011
Approval date [4] 289963 0
10/10/2011
Ethics approval number [4] 289963 0
HR 123/2011

Summary
Brief summary
This study aims to determine whether a tailored educational package can reduce psychological distress in women with breast cancer who are referred for radiotherapy. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or more who has been diagnosed with breast cancer for which you are about to commence a course of radiation therapy that will be more than 4 weeks. Trial details Participants in this trial will be allocated to one of two groups. One group will receive the standard information provided in radiation oncology. The other group will undergo an innovative radiotherapy program, consisting of two one-on-one 20 minute educational sessions with their radiotherapist. During the consultations the radiation therapist will discuss the procedure that is about to occur, what will be expected of the patient, any immediate discomfort or pain they should anticipate, and any short or long term side effects that may result from the procedure. Participants will be assessed on four occasions before and after treatment to determine their psychological distress levels, specific concerns about radiotherapy, knowledge of radiotherapy, and preparedness for treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33097 0
Dr Georgia
Address 33097 0
Faculty of Health Sciences
Curtin University
GPO Box U1987
Perth WA 6845
Country 33097 0
Australia
Phone 33097 0
+61 8 9266 1762
Fax 33097 0
Email 33097 0
g.halkett@curtin.edu.au
Contact person for public queries
Name 16344 0
Dr Dr Georgia Halkett
Address 16344 0
Faculty of Health Sciences
Curtin University
GPO Box U1987
Perth WA 6845
Country 16344 0
Australia
Phone 16344 0
+61 8 9266 1762
Fax 16344 0
+61 8 9266 1770
Email 16344 0
g.halkett@curtin.edu.au
Contact person for scientific queries
Name 7272 0
Dr Dr Georgia Halkett
Address 7272 0
Curtin University
GPO Box U1987
Perth
WA 6845
Country 7272 0
Australia
Phone 7272 0
+61 8 9266 1762
Fax 7272 0
+61 8 9266 1770
Email 7272 0
g.halkett@curtin.edu.au