ANZCTR - Registration

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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]

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

Premenopausal breast cancer

Postmenopausal breast cancer

Obesity

Condition category

Condition code

Cancer

Breast

Diet and Nutrition

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]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

Weight loss: % change from initial body weight measured using calibrated digital scales

Timepoint [1]

Baseline, 12 weeks (end-of-intervention)

Secondary outcome [2]

Body composition and bone mineral density; Dual-energy X-ray Absorptiometry (DEXA)

Timepoint [2]

Baseline, 12 weeks (end-of-intervention)

Secondary outcome [3]

Dietary intake and adherence; Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)

Timepoint [3]

Baseline, 6 weeks and 12 weeks (end-of-intervention)

Secondary outcome [4]

Physical activity and sedentary time: activPAL3 inclinometer; Actigraph GT3X+ accelerometer; Active Australia survey

Timepoint [4]

Baseline, 12 weeks (end-of-intervention)

Secondary outcome [5]

Menopausal symptoms: Greene Climacteric Scale

Timepoint [5]

Baseline

Secondary outcome [6]

Quality of life: FACT-B

Timepoint [6]

Baseline, 12 weeks (end-of-intervention)

Secondary outcome [7]

Depression and anxiety: Hospital Anxiety and Depression Scale (HADS)

Timepoint [7]

Baseline, 12 weeks (end-of-intervention)

Secondary outcome [8]

Body Image: Body Image and Relationships Scale (BIRS)

Timepoint [8]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

National Breast Cancer Foundation

Address [1]

GPO Box 4126
Sydney
NSW 2001

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland Human Research Ethics Committee

Ethics committee address [1]

Research & Innovation Division
Cumbrae-Stewart Building (72)
The University of Queensland
St Lucia Qld 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/02/2019

Approval date [1]

14/06/2019

Ethics approval number [1]

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

Ms Zoe Thomson

Address

School of Public Health
Level 4 Public Health Building, Herston
The University of Queensland
Herston Rd
Herston QLD 4006

Country

Australia

Phone

+61 7 3365 5163

Fax

z.thomson@uq.edu.au

Contact person for public queries

Name

Zoe Thomson

Address

School of Public Health
Level 4 Public Health Building, Herston
The University of Queensland
Herston Rd
Herston QLD 4006

Country

Australia

Phone

+61 7 3365 5163

Fax

z.thomson@uq.edu.au

Contact person for scientific queries

Name

Zoe Thomson

Address

School of Public Health
Level 4 Public Health Building, Herston
The University of Queensland
Herston Rd
Herston QLD 4006

Country

Australia

Phone

+61 7 3365 5163

Fax

z.thomson@uq.edu.au

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.	Type	Email	Attachment
3561	Ethical approval	z.thomson@uq.edu.au	377010-(Uploaded-19-07-2019-13-01-32)-Study-related document.pdf
3562	Study protocol	z.thomson@uq.edu.au
3563	Informed consent form	z.thomson@uq.edu.au

Results publications and other study-related documents

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