Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000800628
Ethics application status
Approved
Date submitted
15/07/2014
Date registered
28/07/2014
Date last updated
18/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Women's Wellness after Cancer Program
Scientific title
The Women’s Wellness after Cancer Program: A National Multisite Randomised Clinical Trial of an E-Health Enables Lifestyle Modification Intervention to Improve the Health and Wellness of Women after Cancer Treatment.
Secondary ID [1] 284895 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
WWACP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gynaecological cancer 292352 0
Breast Cancer 292353 0
Haematological Cancer 292354 0
Condition category
Condition code
Cancer 292676 292676 0 0
Breast
Cancer 292677 292677 0 0
Ovarian and primary peritoneal
Cancer 292678 292678 0 0
Leukaemia - Acute leukaemia

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 previously treated for haematological, breast and gynaecological cancers. 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 an interactive web interface. The iBook will encourage women to bring together the 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 plan ahead for their exercise in the following week. Participants will receive access to self-directed resources (via the website) and personal consultations (via videoconference) with a nurse. Three individual, virtual 30 minute consultations at 0, 6 and 12 weeks will be provided by a registered nurse trained in the intervention.
Intervention code [1] 289709 0
Lifestyle
Intervention code [2] 289710 0
Behaviour
Comparator / control treatment
Usual care (post treatment) comprising of general information during clinic visits eg. diet, exercise, support.
Control group
Active

Outcomes
Primary outcome [1] 292521 0
A change in health related quality of life as measured by The Functional Assessment of Cancer Therapy-General (FACT-G)
Timepoint [1] 292521 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [1] 309137 0
Anthropometry, using standard protocols: including measures of height, weight, BMI, and waist measurements.
Timepoint [1] 309137 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [2] 309138 0
Habitual Dietary intake - Food frequency questionnaire
Timepoint [2] 309138 0
Baseline , 12 weeks and 24 weeks
Secondary outcome [3] 309139 0
Physical activity - using validated International Physical Activity Questionnaire (IPAQ)
Timepoint [3] 309139 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [4] 309140 0
Sleep activity and quality - Pittsburgh sleep quality index
Timepoint [4] 309140 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [5] 309141 0
Stress, anxiety and depression - Perceived Stress, and List of Threatening Experiences (LTE), Connor-Davidson Resilience Scale, Zung self-rated anxiety scale, Centre for Epidemiologic Studies Depression Scale.
Timepoint [5] 309141 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [6] 309458 0
Menopausal symptoms - Greene Climacteric Scale
Timepoint [6] 309458 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [7] 309459 0
Body image, sexuality and sexual function. These will be assessed with validated tools incorporated into the online survey (the Body Image Scale, the Female Sexual Function Index, and the Emotional Intimacy Scale).
Timepoint [7] 309459 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [8] 309460 0
Internet and technology use. This will be assessed with 13 questions incorporated into the online survey (e.g. how often do you access the internet?; have you ever used health-related mobile apps?; how often to you access health forums?)
Timepoint [8] 309460 0
Baseline, 12 weeks and 24 weeks

Eligibility
Key inclusion criteria
(1) Completed chemotherapy (primary or adjuvant) and/or radiotherapy within the past 24 months for breast, blood and/or gynecological cancer (2) Able to speak and read Level 10 English. Participants on maintenance endocrine treatments will be included.
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Metastatic or advanced cancer and inoperable or active loco-regional disease (2) Any clinical, cognitive or psychiatric contraindication identified by treating staff.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited by site Research Assistants, or will register interest via an online website, and will send consent form via surface mail. Participants will be allocated an ID number by the data manager, and randomised to intervention or control by a blinded third party. All other team members will be blinded to participant ID or intervention group membership.
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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The extended CONSORT statement for RCTs will be adhered to when reporting. Baseline measures and participant characteristics will be initially compared to assess for imbalances and differences between groups. Baseline and within-group differences over time will be assessed for all variables of interest using paired t-tests for continuous variables and chi-square tests for categorical variables. Primary endpoint (HRQoL): Between group differences at 12 and 24 weeks will be analysed using a linear mixed model and the difference in variables of interest at 12 and 24 weeks of HRQoL. Secondary endpoints: Linear mixed models will be used to analyse secondary outcomes such as energy, macronutrient and micronutrient intake, body fatness, levels of physical activity, alcohol and smoking, after determining the change score in each variable of interest. Secondary stratification analysis by BMI and sociodemographic variables will also be performed. Logistic regression models will be used to examine predictors of quality of life including baseline quality of life, age and socio demographic variables. This includes exploring the rurality of the women according to the classifications of highly accessible, accessible, moderately accessible, remote and very remote location suggested by the ARIA classification.

To estimate the required sample size, a greater than five point difference on the FACT-G total score is associated with meaningful differences on clinical and subjective indicators[37]. To achieve 90% power and a 95% confidence interval (a=0.05), the two study arms would require 215 participants each, assuming a standard deviation of 16 and an observed difference of 5 units after the 12 week intervention. Assuming 10% attrition and 15% non-responders the minimum sample size required for each group is 268, with a total sample size of 536.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2014
Actual
21/10/2014
Date of last participant enrolment
Anticipated
1/09/2015
Actual
31/03/2016
Date of last data collection
Anticipated
1/10/2016
Actual
23/10/2016
Sample size
Target
536
Accrual to date
Final
351
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 2687 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 2689 0
The Wesley Hospital - Auchenflower
Recruitment hospital [3] 2690 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [4] 2692 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [5] 2693 0
Royal Prince Alfred Hospital - Camperdown

Funding & Sponsors
Funding source category [1] 289520 0
Government body
Name [1] 289520 0
NHMRC
Country [1] 289520 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Rd, Kelvin Grove 4059
Country
Australia
Secondary sponsor category [1] 288295 0
University
Name [1] 288295 0
Institute of Health and Biomedical Innovation
Address [1] 288295 0
60 Musk Avenue
Kelvin Grove 4059
Country [1] 288295 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291350 0
Queensland University of Technology
Ethics committee address [1] 291350 0
Ethics committee country [1] 291350 0
Australia
Date submitted for ethics approval [1] 291350 0
Approval date [1] 291350 0
10/07/2013
Ethics approval number [1] 291350 0
1300000335
Ethics committee name [2] 291351 0
Metro South Human Research Ethics Committee`
Ethics committee address [2] 291351 0
Ethics committee country [2] 291351 0
Australia
Date submitted for ethics approval [2] 291351 0
Approval date [2] 291351 0
28/08/2013
Ethics approval number [2] 291351 0
HREC/13/QPAH/438
Ethics committee name [3] 291352 0
Sydney Local Health District
Ethics committee address [3] 291352 0
Ethics committee country [3] 291352 0
Australia
Date submitted for ethics approval [3] 291352 0
Approval date [3] 291352 0
04/10/2013
Ethics approval number [3] 291352 0
HREC/13/RPAH/366
Ethics committee name [4] 291353 0
Saint John of God Health Care
Ethics committee address [4] 291353 0
Ethics committee country [4] 291353 0
Australia
Date submitted for ethics approval [4] 291353 0
Approval date [4] 291353 0
09/10/2013
Ethics approval number [4] 291353 0
650

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

Contacts
Principal investigator
Name 49586 0
Prof Debra Anderson
Address 49586 0
School of Nursing and Midwifery
Griffith University / Menzies Health Institute
Building G16, Clinical Sciences
Gold Coast Campus
Parklands Drive
Southport
Queensland 4222
Country 49586 0
Australia
Phone 49586 0
+61 7 5552 8733
Fax 49586 0
Email 49586 0
[email protected]
Contact person for public queries
Name 49587 0
Janine Porter-Steele
Address 49587 0
School of Nursing and Midwifery
Griffith University / Menzies Health Institute
Building G16, Clinical Sciences
Gold Coast Campus
Parklands Drive
Southport
Queensland 4222
Country 49587 0
Australia
Phone 49587 0
P: +61 7 5552 8935 +61 7 466 269 562
Fax 49587 0
Email 49587 0
[email protected]
Contact person for scientific queries
Name 49588 0
Debra Anderson
Address 49588 0
School of Nursing and Midwifery
Griffith University / Menzies Health Institute
Building G16, Clinical Sciences
Gold Coast Campus
Parklands Drive
Southport
Queensland 4222
Country 49588 0
Australia
Phone 49588 0
+61 7 5552 8733
Fax 49588 0
Email 49588 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseThe Women's wellness after cancer program: A multisite, single-blinded, randomised controlled trial protocol.2017https://dx.doi.org/10.1186/s12885-017-3088-9
EmbaseDetermining the psychometric properties of the Greene Climacteric Scale (GCS) in women previously treated for breast cancer: A pooled analysis of data from the Women's Wellness after Cancer Programs.2022https://dx.doi.org/10.1016/j.maturitas.2022.02.003
EmbaseSleep and health-related quality of life in women following a cancer diagnosis: results from the Women's Wellness after Cancer Program in Australia.2022https://dx.doi.org/10.1007/s00520-022-07429-0
N.B. These documents automatically identified may not have been verified by the study sponsor.