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Trial registered on ANZCTR


Registration number
ACTRN12612001175864
Ethics application status
Approved
Date submitted
5/11/2012
Date registered
6/11/2012
Date last updated
29/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a Pilot Breast Cancer Survivorship Care Plan in New Zealand
Scientific title
A study involving early breast cancer patients upon completion of active treatment to determine their views on a pilot breast cancer survivorship care plan designed for a New Zealand context.
Secondary ID [1] 281496 0
Nil
Universal Trial Number (UTN)
U1111-1136-7211
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 287767 0
Breast cancer survivorship care plan 287770 0
Condition category
Condition code
Cancer 288113 288113 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pilot Survivorship Care Plan
The pilot SCP booklet is a 24 page booklet that covers the subjects of: Summary of your diagnosis; Summary of your treatment; Follow up; How your body and mind may change after treatment; Sexuality and fertility after breast cancer treatment; Breast cancer in the family/whanau; Breast cancer in men; Breast reconstruction and prostheses; How can you tell if your breast cancer has come back?; What can you do to stay healthy?; Looking ahead with your family/whanau; Useful contacts and websites. The booklet is a combination of patient information, space for patient’s individual details to be entered, space for patients to make their own notes and pictures.
After screening eligible patients for the study and obtaining informed written consent, an appointment will be made for the patient to meet with the CNS Lead Breast Care. She will introduce the patient to the pilot SCP, educate them on its use and complete the sections which record the details of that patient’s individual diagnosis and treatment. The patient will then have that pilot SCP to keep for their personal use.
Six months following this appointment the patient will be sent a self-report questionnaire to complete and then return to the study team.
All standard follow up care and assessments will continue with their GP and/or Specialist as per standard follow up care.
Intervention code [1] 286010 0
Lifestyle
Comparator / control treatment
No treatment - this is a single group study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288315 0
To determine the views of breast cancer patients regarding a pilot breast cancer SCP designed for a New Zealand context.
Timepoint [1] 288315 0
6 months after end of active breast cancer treatment (excluding adjuvant hormonal therapy or herceptin) using self-report questionnaire
Secondary outcome [1] 299833 0
To determine if there are particular areas of the pilot SCP that require modification.
Timepoint [1] 299833 0
6 months after end of active breast cancer treatment (excluding adjuvant hormonal therapy or herceptin) using self-report questionnaire
Secondary outcome [2] 299834 0
To determine if the method of providing the SCP to the patient is suitable.
Timepoint [2] 299834 0
6 months after end of active breast cancer treatment (excluding adjuvant hormonal therapy or herceptin) using self-report questionnaire
Secondary outcome [3] 299835 0
To determine levels of anxiety and depression in breast cancer patients 6 months after the completion of treatment.
Timepoint [3] 299835 0
6 months after end of active breast cancer treatment (excluding adjuvant hormonal therapy or herceptin) using Hospital Anxiety and Depression Scale in self-report questionnaire

Eligibility
Key inclusion criteria
1. Females or males with histologically diagnosed early breast cancer who have undergone surgery alone or just completed adjuvant chemotherapy and/or radiation therapy if this is required. Patients can be receiving adjuvant hormone therapy or adjuvant herceptin therapy.
2. Age >=18 yrs.
3. Able to read English proficiently.
4. Willing and able to comply with all study requirements.
5. Signed, written informed consent.
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 have a histological breast cancer diagnosis.
2. Patients with metastatic breast cancer.
3. Patients still receiving adjuvant chemotherapy or radiation therapy.
4. Life expectancy of less than 6 months.
5. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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 outside Australia
Country [1] 4669 0
New Zealand
State/province [1] 4669 0
Manawatu/Taranaki

Funding & Sponsors
Funding source category [1] 286276 0
Self funded/Unfunded
Name [1] 286276 0
Address [1] 286276 0
Country [1] 286276 0
Funding source category [2] 286277 0
Charities/Societies/Foundations
Name [2] 286277 0
Cancer Society of New Zealand Central Districts Division Inc
Address [2] 286277 0
PO Box 5096
Palmerston North 4441
Country [2] 286277 0
New Zealand
Primary sponsor type
Hospital
Name
Regional Cancer Treatment Service, MidCentral Health DHB
Address
Palmerston North Hospital
Private Bag 11036
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 285070 0
None
Name [1] 285070 0
Address [1] 285070 0
Country [1] 285070 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288347 0
Health and Disability Ethics Committee
Ethics committee address [1] 288347 0
Ministry of Health
Ethics Department
Reception - Ground Floor
20 Aitken Street
Thorndon
Wellington
Ethics committee country [1] 288347 0
New Zealand
Date submitted for ethics approval [1] 288347 0
12/11/2012
Approval date [1] 288347 0
23/11/2012
Ethics approval number [1] 288347 0
NZ/1/9A81014

Summary
Brief summary
The impact of a breast cancer diagnosis and the different treatments involved can be immense and have long term effects on both a patient’s physical and emotional wellbeing. The use of survivorship care plans (SCPs) has been found to help alleviate the challenges of cancer survivorship. Although SCPs are widely accepted and used internationally, there are no published studies on the relevance and importance of developing a SCP for the New Zealand population.
We have created a pilot SCP booklet called “Thriving After Breast Cancer: The years ahead” using information gained from breast cancer patients attending focus groups we organized. The pilot booklets have been published with funding through a Cancer Society scholarship.
We would like to assess whether the pilot booklet addresses the needs of breast cancer patients, if it needs to be modified and whether we can offer this booklet to all breast cancer patients in our DHB.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34919 0
Dr Claire Hardie
Address 34919 0
Dept of Radiation Oncology
Regional Cancer Treatment Service
Palmerston North Hospital
Private Bag 11036
Palmerston North
Country 34919 0
New Zealand
Phone 34919 0
+64 350 8439
Fax 34919 0
Email 34919 0
claire.hardie@midcentraldhb.govt.nz
Contact person for public queries
Name 18166 0
Dr Dr Claire Hardie
Address 18166 0
Dept of Radiation Oncology
Regional Cancer Treatment Service
Palmerston North Hospital
Private Bag 11036
Palmerston North 4442
Country 18166 0
New Zealand
Phone 18166 0
+64 6350 8439
Fax 18166 0
Email 18166 0
claire.hardie@midcentraldhb.govt.nz
Contact person for scientific queries
Name 9094 0
Dr Dr Claire Hardie
Address 9094 0
Dept of Radiation Oncology
Regional Cancer Treatment Service
Palmerston North Hospital
Private Bag 11036
Palmerston North 4442
Country 9094 0
New Zealand
Phone 9094 0
+64 6350 8439
Fax 9094 0
Email 9094 0
claire.hardie@midcentraldhb.govt.nz

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