Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000441112
Ethics application status
Approved
Date submitted
6/03/2019
Date registered
18/03/2019
Date last updated
29/07/2019
Date data sharing statement initially provided
18/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Living Well after Breast Cancer: supporting younger women to manage their weight with a partial meal replacement diet
Scientific title
Living Well after Breast Cancer: a pilot study exploring physiological differences between women with premenopausal breast cancer, and postmenopausal women with breast cancer, and their response to a partial meal replacement dietary intervention
Secondary ID [1] 297450 0
Nil known
Universal Trial Number (UTN)
U1111-1228-8575
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 311634 0
Premenopausal breast cancer 311635 0
Postmenopausal breast cancer 311901 0
Obesity 311934 0
Condition category
Condition code
Cancer 310256 310256 0 0
Breast
Diet and Nutrition 310257 310257 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive a 12-week dietary program with regular individual sessions with an Accredited Practising Dietitian (APD). Women will have an initial face-to-face session with an APD, and 3-7 telephone contacts over the 12 weeks.

Participants will be prescribed meal replacement products (KickStart soups and shakes) to replace two meals per day for a period of 12 weeks. Participants will be supplied with 2 meal replacement products (885kJ per meal replacement product) per day for 11 weeks followed by 1-2 shakes per day for the remaining week (based on the individual’s requirements and preferences) at no cost to the participant. On the partial meal replacement diet, participants will be advised to eat a main meal (lunch or dinner) consisting of 2 cups of non-starchy vegetables, lean protein (serving based on protein requirements) and 1 teaspoon of olive oil. Participant’s protein requirements will be calculated, based on 1-1.2g/kg of actual body weight to minimise loss of fat free mass. During the course of the meal replacement diet, participants are advised to consume 2 litres of water per day. Participants will also receive a detailed booklet designed specifically for the study, with information about non-starchy vegetables approved on the diet, additions to the meal replacement products to vary the flavour and recipe ideas for the food based meal. The booklet also includes tips for managing side effects (such as constipation) and addresses frequently asked questions.

During the final intervention contact in the 12 week intervention, participants will be prescribed a recommended kilojoule intake based on age and baseline weight to maintain weigh loss. The APD will provide individualised advice including improving portion control and eating regular meals along with kilojoule counting to achieve maintenance of weight loss. In addition, all participants will be encouraged to aim for a diet high in vegetables (5 serves per day), fruits (2 serves per day), whole grains, fibre (greater than or equal to 25g per day) and low in saturated fat, consistent with guidelines for breast cancer survivorship, weight management and the Australian dietary guidelines for the general population.
Intervention code [1] 313704 0
Lifestyle
Intervention code [2] 313705 0
Behaviour
Intervention code [3] 313958 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319304 0
Feasibility, measured by:
i) participant reach as measured by consent rates (#consenting / # interested and eligible / 100%)
ii) intervention adherence (#completed sessions / #scheduled sessions, x100%)
iii) participant retention (#completed follow-up testing /#completed baseline testing x100%);
iv) participant satisfaction (participant satisfaction survey designed for this study, semi-structured interview)
Timepoint [1] 319304 0
i) participant reach (pre-intervention)
ii) intervention adherence
iii) participant retention: 12 weeks (baseline/end-of-intervention)
iv) participant satisfaction: 12 weeks (end-of-intervention)
Secondary outcome [1] 367641 0
Weight loss: % change from initial body weight measured using calibrated digital scales
Timepoint [1] 367641 0
Baseline, 12 weeks (end-of-intervention)
Secondary outcome [2] 367645 0
Body composition and bone mineral density; Dual-energy X-ray Absorptiometry (DEXA)
Timepoint [2] 367645 0
Baseline, 12 weeks (end-of-intervention)
Secondary outcome [3] 367646 0
Dietary intake and adherence; Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
Timepoint [3] 367646 0
Baseline, 6 weeks and 12 weeks (end-of-intervention)
Secondary outcome [4] 367647 0
Physical activity and sedentary time: activPAL3 inclinometer; Actigraph GT3X+ accelerometer; Active Australia survey
Timepoint [4] 367647 0
Baseline, 12 weeks (end-of-intervention)
Secondary outcome [5] 367648 0
Menopausal symptoms: Greene Climacteric Scale
Timepoint [5] 367648 0
Baseline
Secondary outcome [6] 367649 0
Quality of life: FACT-B
Timepoint [6] 367649 0
Baseline, 12 weeks (end-of-intervention)
Secondary outcome [7] 367650 0
Depression and anxiety: Hospital Anxiety and Depression Scale (HADS)
Timepoint [7] 367650 0
Baseline, 12 weeks (end-of-intervention)
Secondary outcome [8] 367651 0
Body Image: Body Image and Relationships Scale (BIRS)
Timepoint [8] 367651 0
Baseline

Eligibility
Key inclusion criteria
Women with premenopausal breast cancer
- Diagnosed with invasive breast cancer (stage I-IIIc)
- Oestrogen receptor positive disease (ER+)
- Premenopausal at diagnosis
- BMI greater than or equal to 27kg/m2
- Finished primary treatment (i.e. surgery, chemotherapy and/or radiotherapy)
- Received chemotherapy treatment for breast cancer

Women with postmenopausal breast cancer
• Diagnosed with invasive breast cancer (stage I-IIIc)
• Oestrogen receptor positive disease (ER+)
• Postmenopausal at diagnosis
• BMI greater than or equal to 27kg/m2
• Finished primary treatment (i.e. surgery, chemotherapy and/or radiotherapy)
• Aged between 58-63 years at diagnosis (under 65 years at study enrolment)
• Received chemotherapy treatment for breast cancer
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with premenopausal breast cancer
- Ductal carcinoma in situ (DCIS; stage 0), distant metastases (stage IV) or triple negative breast cancer (TNBC)
- Diagnosed more than two years ago
- Currently pregnant or plan to conceive during the study period
- Contraindication to participating in an unsupervised program - active heart disease, impaired mobility, Insulin dependent diabetes, low liver/kidney function (from blood test)
- Currently taking or planning to start taking weight loss medications
- Insufficient English to complete assessments and participate in the intervention
- Unable to travel to Brisbane to complete study assessments
- Reporting depression/anxiety as a current significant problem that would interfere with study participation.
- Allergy or intolerance to soy, dairy or lactose

Women with postmenopausal breast cancer
• Ductal carcinoma in situ (DCIS; stage 0), distant metastases (stage IV) or triple negative breast cancer (TNBC)
• Diagnosed more than two years ago
• Currently pregnant or plan to conceive during the study period
• Contraindication to participating in an unsupervised program - active heart disease, impaired mobility, Insulin dependent diabetes, low liver/kidney function (from blood test)
• Currently taking or planning to start taking weight loss medications
• Insufficient English to complete assessments and participate in the intervention
• Unable to travel to Brisbane to complete study assessments
• Reporting depression/anxiety as a current significant problem that would interfere with study participation.
• Allergy or intolerance to soy, dairy or lactose

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)
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
Recruiting
Date of first participant enrolment
Anticipated
3/06/2019
Actual
11/07/2019
Date of last participant enrolment
Anticipated
5/08/2019
Actual
Date of last data collection
Anticipated
12/11/2019
Actual
Sample size
Target
20
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 302130 0
Charities/Societies/Foundations
Name [1] 302130 0
National Breast Cancer Foundation
Country [1] 302130 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Public Health
The University of Queensland
Herston Road
Herston QLD 4072
Country
Australia
Secondary sponsor category [1] 301967 0
None
Name [1] 301967 0
Address [1] 301967 0
Country [1] 301967 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302699 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 302699 0
Research & Innovation Division
Cumbrae-Stewart Building (72)
The University of Queensland
St Lucia Qld 4072
Ethics committee country [1] 302699 0
Australia
Date submitted for ethics approval [1] 302699 0
21/02/2019
Approval date [1] 302699 0
14/06/2019
Ethics approval number [1] 302699 0
2019000379

Summary
Brief summary
The aim of this study is to explore physiological and psychosocial differences between women classified as overweight/obese with premenopausal breast cancer, and postmenopausal breast cancer, and compare their response to a partial meal replacement dietary intervention.

Who is it for?
You may be eligible to participate in this study if you are:
• A female who was premenopausal at the time of being diagnosed with breast cancer, and has finished primary treatment (surgery, chemotherapy and radiation); or
• A female who was postmenopausal at the time of being diagnosed with breast cancer, and has finished primary treatment (surgery, chemotherapy and radiation).

Study details
All participants in this study will undergo a dietary intervention. This will consist of a partial meal replacement diet in conjunction with face-to-face sessions, telephone calls and a meal replacement booklet to support women to lose weight and increase exercise. All women will receive a 12-week dietary program with regular sessions with an Accredited Practising Dietitian. Participants will be prescribed meal replacement products (KickStart soups and shakes) to replace two meals per day for a period of 11 weeks followed by 1-2 shakes per day for the remaining week (based on the individual’s requirements and preferences). On the partial meal replacement diet, participants will be advised to eat a main meal (lunch or dinner) consisting of 2 cups of non-starchy vegetables, lean protein (serving based on protein requirements of 1-1.2g/kg body weight) and 1 teaspoon of olive oil. Data will be collected at baseline and 12 weeks (end-of-intervention).

All participants will be undergo assessments at enrolment, 6 weeks and 12 weeks (end-of-intervention) in order to evaluate any changes in body mass, body composition, dietary intake, physical activity, quality of life and psychological well-being. It is hoped that this study will enable us to determine whether a larger trial would be feasible.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91098 0
Ms Zoe Thomson
Address 91098 0
School of Public Health
Level 4 Public Health Building, Herston
The University of Queensland
Herston Rd
Herston QLD 4006
Country 91098 0
Australia
Phone 91098 0
+61 7 3365 5163
Fax 91098 0
Email 91098 0
[email protected]
Contact person for public queries
Name 91099 0
Ms Zoe Thomson
Address 91099 0
School of Public Health
Level 4 Public Health Building, Herston
The University of Queensland
Herston Rd
Herston QLD 4006
Country 91099 0
Australia
Phone 91099 0
+61 7 3365 5163
Fax 91099 0
Email 91099 0
[email protected]
Contact person for scientific queries
Name 91100 0
Ms Zoe Thomson
Address 91100 0
School of Public Health
Level 4 Public Health Building, Herston
The University of Queensland
Herston Rd
Herston QLD 4006
Country 91100 0
Australia
Phone 91100 0
+61 7 3365 5163
Fax 91100 0
Email 91100 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data collected during the trial from participants that have consented for their data to be used in future research.
When will data be available (start and end dates)?
Immediately following publication of results and up to 5 years following.
Available to whom?
Data will be available to researchers only. Researchers wishing to access data will need to contact the Principal Investigator and seek approval from The University of Queensland Human Ethics Committee.
Available for what types of analyses?
Since this is a small pilot study, data will be available for exploratory analysis only. Research questions for subsequent analyses will need to be separate to the research questions listed in the current study.
How or where can data be obtained?
Access via secure data transfer with approval by the Principal Investigator and The University of Queensland Ethics Committee.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3561Ethical approval  [email protected] 377010-(Uploaded-19-07-2019-13-01-32)-Study-related document.pdf
3562Study protocol  [email protected]
3563Informed consent form  [email protected]



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.