Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001087640
Ethics application status
Approved
Date submitted
14/09/2014
Date registered
10/10/2014
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Younger Women's Wellness after Cancer program: A pilot study of an E-Health Enabled Lifestyle Modification Intervention.
Scientific title
The Younger Women's Wellness after Cancer program: A pilot study of an E-Health Enabled Lifestyle Modification Intervention to Improve the Health and Wellness of Younger Women after Cancer Treatment.
Secondary ID [1] 284902 0
NIL
Universal Trial Number (UTN)
Trial acronym
YWWACP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 292361 0
Gynaecological cancer 292362 0
Haematological cancer 299774 0
Condition category
Condition code
Cancer 292683 292683 0 0
Breast
Cancer 292684 292684 0 0
Ovarian and primary peritoneal
Cancer 292685 292685 0 0
Cervical (cervix)

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 20 and 50 years of age who have previously been treated for breast, haematological 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 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 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] 289719 0
Prevention
Intervention code [2] 289720 0
Lifestyle
Intervention code [3] 289721 0
Behaviour
Comparator / control treatment
Usual care (post treatment) comprising of general information during clinic visits e.g. diet, exercise, support.
Control group
Active

Outcomes
Primary outcome [1] 292529 0
The primary outcome measure is change in health-related quality of life as measured by The Functional Assessment of Cancer Therapy-General (FACT-G)
Timepoint [1] 292529 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [1] 309155 0
Anthropometry using standard protocols; including measures of height, weight, waist-to-hip ratio and BMI.
Timepoint [1] 309155 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [2] 309156 0
Habitual dietary intake will be monitored through the Food Frequency Questionnaire
Timepoint [2] 309156 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [3] 309157 0
Physical activity will be measured using the validated International Physical Activity Questionnaire (IPAQ)
Timepoint [3] 309157 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [4] 309158 0
Sleep activity and quality - Pittsburgh sleep quality index
Timepoint [4] 309158 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [5] 309159 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] 309159 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [6] 310471 0
Menopausal symptoms - Greene Climacteric Scale
Timepoint [6] 310471 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [7] 310472 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] 310472 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [8] 310473 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] 310473 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [9] 310707 0
Health behaviours, including smoking and alcohol consumption, will be assessed in the online survey at baseline (0 weeks), 12 week and 24 weeks. Alcohol consumption is also measured as part of the Food Frequency Questionnaire (described above).
Timepoint [9] 310707 0
Baseline, 12 weeks and 24 weeks
Secondary outcome [10] 326377 0
The FACT-Cog tool has been included in the online component of the survey and is a 37 questionnaire assessing cognitive function.
Timepoint [10] 326377 0
baseline, 12 weeks and 24 weeks

Eligibility
Key inclusion criteria
(1) Completed surgery or chemotherapy (primary or adjuvant) and/or radiotherapy for blood, breast and/or gynaecological cancer (2) Able to speak and read Level 10 English (3) Must have access to internet (4) not currently receiving any cytotoxic maintenance treatments
Minimum age
20 Years
Maximum age
50 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 (3) Participants on cytotoxic maintenance treatments will be excluded

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)
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
A difference greater than a five point difference on the FACT-G total score is associated with meaningful differences on clinical and subjective indicators. 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.
The current study is a pilot study, and we are therefore recruiting a minimum of 10% (or 30 to 40 participants for each study condition) into our program.
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 socio-demographic 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.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
29/05/2015
Actual
29/05/2015
Date of last participant enrolment
Anticipated
30/12/2016
Actual
27/01/2017
Date of last data collection
Anticipated
7/08/2017
Actual
7/08/2017
Sample size
Target
80
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2697 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 6377 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 8697 0
4006 - Herston
Recruitment postcode(s) [2] 13927 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 289529 0
Hospital
Name [1] 289529 0
Royal Brisbane and Women's Hospital - Diamond Care Grant
Country [1] 289529 0
Australia
Funding source category [2] 294221 0
Hospital
Name [2] 294221 0
Princess Alexandra Hospital.
Country [2] 294221 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Road, Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 288216 0
Hospital
Name [1] 288216 0
Royal Brisbane and Women's Hospital
Address [1] 288216 0
Butterfield street, Herston Qld 4006
Country [1] 288216 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295632 0
Royal Brisbane Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 295632 0
Ethics committee country [1] 295632 0
Australia
Date submitted for ethics approval [1] 295632 0
14/07/2014
Approval date [1] 295632 0
01/08/2014
Ethics approval number [1] 295632 0
HREC/14/QRBW/281

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

Contacts
Principal investigator
Name 49610 0
Prof Debra Anderson
Address 49610 0
School of Nursing and Midwifery
Menzies Health Institute Queensland
Griffith University
58 Parklands Dr, Southport QLD 4215, Australia
Country 49610 0
Australia
Phone 49610 0
+61 7 555 28403
Fax 49610 0
+61 7 3138 3814
Email 49610 0
[email protected]
Contact person for public queries
Name 49611 0
Janine Porter-Steele
Address 49611 0
Griffith University | Menzies Health Institute
Gold Coast Campus
Clinical Sciences 2 (G16), Gold Coast. QLD. Australia. 4222
Country 49611 0
Australia
Phone 49611 0
+61 7 55 528935 +61 466 269 562
Fax 49611 0
Email 49611 0
[email protected]
Contact person for scientific queries
Name 49612 0
Debra Anderson
Address 49612 0
School of Nursing and Midwifery
Menzies Health Institute Queensland
Griffith University
58 Parklands Dr, Southport QLD 4215, Australia
Country 49612 0
Australia
Phone 49612 0
+61 7 555 28403
Fax 49612 0
+617 3138 3814
Email 49612 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

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