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Trial registered on ANZCTR


Registration number
ACTRN12620000260921
Ethics application status
Approved
Date submitted
29/01/2020
Date registered
27/02/2020
Date last updated
27/02/2020
Date data sharing statement initially provided
27/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Kowhai Study: The Younger Women's Wellness Program After Breast Cancer - A feasibility study of an e-health enabled lifestyle modification intervention.
Scientific title
Kowhai Study: The Younger Women's Wellness Program After Breast Cancer - A feasibility study of an e-health enabled lifestyle modification intervention to improve health-related quality of life and prevent or modify the risk of chronic disease in New Zealand women previously treated for breast cancer.
Secondary ID [1] 300115 0
HRC Ref: 19/622
Secondary ID [2] 300384 0
Protocol ID: CTNZ-2018-04
Universal Trial Number (UTN)
U1111-1235-1617
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 315648 0
Condition category
Condition code
Cancer 313938 313938 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 12 week, e-health enabled, structured health promotion intervention targeted at improving health related quality of life and reducing chronic disease risk factors in women between 18 and 50 years of age who have previously been treated for cancer. All women in the intervention arm will receive health education material, including a Program Journal (in the form of an interactive iBook), and access to the program website. The iBook includes sections on healthy eating, sleep, exercise advice, tips for managing fatigue and stress, mindfulness, and will encourage women to bring together these various components of the health education provided and incorporate them into their lives over a 12-week period. The iBook includes a weekly exercise planner, where women are encouraged to use this journal daily and to plan ahead for their exercise in the following week. Participants will receive access to self-directed resources (via the website) and three 30-60 minute individual, personalised consultations (via video conference) at weeks 1, 6 and 12 will be provided by a registered nurse trained in the intervention. The nurse consultations will include individual goal setting as well as discussion and health education about physical activity, healthy eating, stress, sleep, menopause and sexuality after cancer and strategies to promote intervention adherence.
Intervention code [1] 316664 0
Prevention
Intervention code [2] 316665 0
Lifestyle
Intervention code [3] 316666 0
Behaviour
Comparator / control treatment
Standard of care (post treatment) comprising of general information from the participant's usual health professional and from cancer support networks such as Pinc and Steel, Breast Cancer Foundation New Zealand and the Divisions of the Cancer Society.
Control group
Active

Outcomes
Primary outcome [1] 322667 0
Composite primary outcome 1.1:
The accessibility, acceptability and uptake of the intervention in a representative population of younger women with invasive breast cancer in New Zealand, including Maori women, women living with greater deprivation, and women living in non-metropolitan areas.
Measure:
- Content analysis of qualitative data collected using qualitative interview (30 minute semi-structured virtual interview) and semi-structured feasibility questionnaire (designed specifically for this study) at week 24.
- Socio-demographics (ethnicity, deprivation and rurality) of non-participants (as recorded in study screening log data).
- Reasons for non-participation (as recorded in study screening log data).
Timepoint [1] 322667 0
24 week assessment.(T3 - 24 weeks post intervention commencement)
Primary outcome [2] 322668 0
Composite primary outcome 1.2:
The sustainability of, and adherence to, the intervention over time.
Measure:
- Content analysis of qualitative data collected using qualitative interview (30 minute semi-structured virtual interview) and semi-structured feasibility questionnaire (designed specifically for this study) at week 24.
- Proportion of participants who discontinue the intervention (as recorded by nurse specialist.)
- Reasons for intervention discontinuation (as recorded by nurse specialist).
Timepoint [2] 322668 0
24 week assessment (T3)
Secondary outcome [1] 379239 0
Participants’ perceptions of measurement burden (intervention and control arms)
Measure:
- Content analysis of qualitative data collected using qualitative interview (30 minute semi-structured virtual interview) and semi-structured feasibility questionnaire (designed specifically for this study) to assess measurement burden.
- Time taken to complete questionnaires (as self-reported by participant in semi-structured feasibility questionnaire).
- Questionnaire completion rates at weeks 12 and 24 (by single measure and all measures combined).
Timepoint [1] 379239 0
12 week (T2) and 24 week (T3) post randomisation and assignment to treatment arm (Intervention vs. Standard of Care).
Secondary outcome [2] 379240 0
The effectiveness of the planned recruitment strategy
Measure:
- Proportions of consenting participants registered on the study.
- Reasons for non-registration/randomisation (as recorded in study screening log).
Timepoint [2] 379240 0
On completion of study recruitment.
Secondary outcome [3] 380044 0
The prevalence components of the intervention in the control group
Measure:
- Self-reported access to support services, and use of any interventions offered, assessed using study specific questionnaire at baseline (T1), 12 week (T2) and 24 week (T3) assessments.
Timepoint [3] 380044 0
Baseline (T1), 12 week (T2) and 24 week (T3) assessments.
Secondary outcome [4] 380045 0
Intervention efficacy - change in waist circumference
Measure:
- Waist circumference measurements collected in intervention and control participants at baseline (T1), 12 week (T2) and 24 week (T3) assessments.
Waist circumference measurements are completed by the participant (in triplicate) under virtual supervision of the Research Assistant adhering to World Health Organisation standardised protocol .
Timepoint [4] 380045 0
Baseline (T1), 12 week (T2) and 24 week (T3) assessments.
Secondary outcome [5] 380046 0
Assess trial methods and procedures (including randomisation and follow-up procedures)
Measures:
- Time to informed consent from submission of participant expression of interest.
- Time to randomisation from study registration.
- Time to randomisation from completion of baseline assessments.
- Time to intervention access from randomisation.
- Proportion of patients randomised who complete week 12 assessments.
- Proportion of patients randomised who complete week 24 assessments.
Timepoint [5] 380046 0
On completion of study recruitment and follow-up.

Eligibility
Key inclusion criteria
1.) Women who have completed any intensive treatment (surgery, chemotherapy, radiotherapy) for breast cancer in the previous 24 months (can be on endocrine therapy).
2.) Aged between 18 years and 50 years (inclusive).
3.) Reside in New Zealand.
4.) Have no metastatic disease.
5.) Have access to the internet.
6.) Own, or have access to, a computer or tablet device.
7.) Willing and able to comply with all study requirements, including intervention, timing and nature of required assessments.
8.) Able to speak and read in English to ensure consent is informed and documentation of participant-reported outcome measures can be adhered to.
9.) Voluntary written informed consent.
Minimum age
18 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.) Any clinical contraindication that precludes safe completion of the program in the judgement of the project team.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The Research Assistant determining if a subject is eligible for inclusion in the trial, and completing study assessments, will be blinded to which group the subject is allocated to. Computer randomisation will be completed by the Study Manager upon completion of study enrolment and baseline assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using computer generated number sequences
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Quantitative analysis:
Between-group differences at 12 and 24 weeks will be estimated using a linear mixed model with a treatment-time interaction. Sensitivity analyses will be used to explore the impact of non-ignorable missing data.

Qualitative analysis:
Qualitative data collected (qualitative interview and semi-structured feasibility questionnaire) at week 24 will be content analysed to assess the study objectives.

Recruitment
Recruitment status
Not yet 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 outside Australia
Country [1] 22274 0
New Zealand
State/province [1] 22274 0

Funding & Sponsors
Funding source category [1] 304554 0
Government body
Name [1] 304554 0
Health Research Council of New Zealand
Address [1] 304554 0
Level 3, ProCare Building
110 Stanley Street
Auckland 1010
Country [1] 304554 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
85 Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 305132 0
None
Name [1] 305132 0
Address [1] 305132 0
Country [1] 305132 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304981 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 304981 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 304981 0
New Zealand
Date submitted for ethics approval [1] 304981 0
20/11/2019
Approval date [1] 304981 0
20/12/2019
Ethics approval number [1] 304981 0
19/STH/215

Summary
Brief summary
Younger women (50 years of age or younger) treated for cancer represent a growing population in New Zealand. While the treatment outcomes of this cohort have improved, their likelihood of developing treatment-related chronic disease such as diabetes and obesity is considerable, and could pose a significant public health issue in the future. The Younger Women’s Wellness after Cancer Program (YWWACP) is a whole-of-lifestyle intervention that enables younger women to self-manage their chronic disease risk. It promotes physical activity, optimal diet, smoking cessation, alcohol reduction, plus strategies for sleep, stress, sexual wellbeing and menopausal symptom management based on the latest evidence. The Kowhai Study will test the YWWACP intervention and proposed trial design for feasibility in a representative sample of younger New Zealand women (50 years of age or younger) after treatment for breast cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98850 0
Prof Alexandra McCarthy
Address 98850 0
School of Nursing
Faculty of Medical Health Sciences
The University of Auckland
85 Park Road
Grafton
Auckland 1142
Country 98850 0
New Zealand
Phone 98850 0
+64 09 923 8418
Fax 98850 0
Email 98850 0
alexandra.mccarthy@auckland.ac.nz
Contact person for public queries
Name 98851 0
Ms Kate Gorton
Address 98851 0
Cancer Trials New Zealand
Faculty of Medical Health Sciences
The University of Auckland
85 Park Road
Grafton
Auckland 1142
Country 98851 0
New Zealand
Phone 98851 0
+64 09 923 4927
Fax 98851 0
Email 98851 0
kate.gorton@auckland.ac.nz
Contact person for scientific queries
Name 98852 0
Dr Bobbi Laing
Address 98852 0
School of Nursing
Faculty of Medical Health Sciences
The University of Auckland
85 Park Road
Grafton
Auckland 1142
Country 98852 0
New Zealand
Phone 98852 0
+64 09 923 8418
Fax 98852 0
Email 98852 0
b.laing@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be available for this feasibility study.
What supporting documents are/will be available?
No other documents available
Summary results
No Results