Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000447853
Ethics application status
Approved
Date submitted
23/02/2021
Date registered
19/04/2021
Date last updated
22/04/2022
Date data sharing statement initially provided
19/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
EMERALD Study: youngEr woMen’s wEllness afteR cAncer feasibiLity stuDy
Scientific title
EMERALD Study: the effect of structured health promotion on youngEr woMen’s wEllness afteR cAncer feasibiLity stuDy
Secondary ID [1] 303017 0
Nil known
Universal Trial Number (UTN)
U1111-1262-6451
Trial acronym
EMERALD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 320081 0
Condition category
Condition code
Cancer 318011 318011 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 12 week 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 specially-designed Program Journal, and access to the study-specific program website. The Book 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 Book 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. It is expected participants will engage with the materials for ~1-2 hours per 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. Adherence to the intervention will be assessed during these consultations.
Intervention code [1] 319303 0
Prevention
Intervention code [2] 319304 0
Lifestyle
Intervention code [3] 319305 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 Cancer Council Queensland.
Control group
Active

Outcomes
Primary outcome [1] 326628 0
Composite primary outcome 1.1:
The accessibility, acceptability and uptake of the intervention in a representative population of younger women with breast cancer in Australia, including women living with greater deprivation, and women living in non-metropolitan areas.
Measure:
- Content analysis of qualitative data collected (semi-structured feasibility questionnaire) to assess the acceptability, accessibility and uptake of the intervention.
- 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] 326628 0
24 week assessment (T2 - 24 weeks post intervention commencement)
Primary outcome [2] 331156 0
Composite primary outcome 1.2:
The sustainability of, and adherence to, the intervention over time.
Measure:
- Content analysis of qualitative data collected (semi-structured feasibility questionnaire).
- Proportion of participants who discontinue the intervention (as recorded by nurse specialist).
- Reasons for intervention discontinuation (as recorded by nurse specialist).
Timepoint [2] 331156 0
24 week assessment (T2 - 24 weeks post intervention commencement)
Secondary outcome [1] 392190 0
Participants’ perceptions of measurement burden.
Measure:
- Content analysis of qualitative data collected (semi-structured feasibility questionnaire) 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] 392190 0
12 week (T1) and 24 week (T2) post randomisation and assignment to treatment arm (Intervention vs. Standard of Care).
Secondary outcome [2] 392191 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] 392191 0
On completion of study recruitment.
Secondary outcome [3] 392192 0
The prevalence components of the intervention in the control group.
Measure:
- Self-reported access to support services, and use of any interventions offered, will be assessed via an online questionnaire (designed specifically for the study) in the control group and reported using 95% CI (as self-reported at weeks 12 and 24)
Timepoint [3] 392192 0
12 week (T1) and 24 week (T2) assessments.
Secondary outcome [4] 392193 0
Intervention efficacy (i.e. change in waist circumference)
Measure:
- Waist circumference measurements are completed by the participant (in triplicate using a study provided anthropometry tape measure) under virtual supervision of the Research Assistant adhering to World Health Organisation standardised protocol. Waist circumference will be compared in intervention and control arms using linear mixed models with a treatment-time interaction.
Timepoint [4] 392193 0
Baseline (T0), 12 week (T1) and 24 week (T2) assessments.
Secondary outcome [5] 392194 0
Assess trial methods and procedures (including randomisation and follow-up procedures) following an audit of the study records.
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] 392194 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 or targeted therapy).
2. Aged between 18 years and 50 years (inclusive).
3. Reside in Australia.
4. Have no metastatic disease/advanced disease.
5. Have access to the internet.
6. Own, or have access to, a computer, tablet device or smartphone.
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
Sex
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. Central randomisation by computer 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 (semi-structured feasibility questionnaire) at week 24 will be content analysed to assess the study objectives.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/04/2021
Actual
8/03/2022
Date of last participant enrolment
Anticipated
14/09/2022
Actual
Date of last data collection
Anticipated
1/03/2023
Actual
Sample size
Target
60
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18202 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 32260 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 307428 0
Charities/Societies/Foundations
Name [1] 307428 0
Wesley Medical Research
Country [1] 307428 0
Australia
Primary sponsor type
Hospital
Name
Choices Wesley Support Centre, The Wesley Hospital
Address
The Wesley Hospital
451 Coronation Drive
Auchenflower, Queensland, 4066
Country
Australia
Secondary sponsor category [1] 308098 0
None
Name [1] 308098 0
Address [1] 308098 0
Country [1] 308098 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307510 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 307510 0
Ethics committee country [1] 307510 0
Australia
Date submitted for ethics approval [1] 307510 0
05/01/2021
Approval date [1] 307510 0
05/02/2021
Ethics approval number [1] 307510 0
202103

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107494 0
Dr Janine Porter-Steele
Address 107494 0
Choices Cancer Support Centre
The Wesley Hospital
451 Coronation Drive
Auchenflower, Queensland, 4066
Country 107494 0
Australia
Phone 107494 0
+61 7 3232 7064
Fax 107494 0
Email 107494 0
[email protected]
Contact person for public queries
Name 107495 0
Sarah Balaam
Address 107495 0
School of Nursing, Midwifery and Social Work
The University of Queensland
St Lucia, Queensland, 4072
Country 107495 0
Australia
Phone 107495 0
+61 400 389 368
Fax 107495 0
Email 107495 0
[email protected]
Contact person for scientific queries
Name 107496 0
Janine Porter-Steele
Address 107496 0
Choices Cancer Support Centre
The Wesley Hospital
451 Coronation Drive
Auchenflower, Queensland, 4066
Country 107496 0
Australia
Phone 107496 0
+61 7 3232 7064
Fax 107496 0
Email 107496 0
[email protected]

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 Supporting Document Provided



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.