Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001381572
Ethics application status
Approved
Date submitted
11/12/2015
Date registered
17/12/2015
Date last updated
17/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Self-compassionate writing for breast cancer survivors: An online intervention
Scientific title
Modifying responses to body-image related concerns for breast cancer survivors with an online self-compassion based writing activity
Secondary ID [1] 288106 0
Nil known
Universal Trial Number (UTN)
u1111-1177-4204
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 296968 0
breast cancer-related lymphoedema 296969 0
Body image disturbance 297081 0
psychological distress 297082 0
Condition category
Condition code
Cancer 297225 297225 0 0
Breast
Mental Health 297317 297317 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 2-group design (control & intervention) assessing the effect of an online writing intervention.
Exposure to intervention occurs once only and for approximately 30 minutes.
Intervention - structured writing with self-compassionate prompts about difficult body image experiences after treatment for breast cancer. The writing prompts are delivered in an online format via a website accessed by participants allocated to the experimental condition. To monitor time spent undertaking the intervention, participants are asked to record their start and finish time on the website.
Intervention code [1] 293413 0
Behaviour
Comparator / control treatment
Control group participants will receive access to a plain version of the website with an unstructured writing activity that will be matched for length and activity duration. The total length of the writing activity is expected to take approximately 30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 296812 0
Body image disturbance
Body Image Scale (BIS), Hopwood, Fletcher, Lee & Ghazal (2001)
Appearance Schema Inventory Revised (ASI-R), Cash (2003)
Timepoint [1] 296812 0
1-week post-intervention
Secondary outcome [1] 319429 0
Body image disturbance
Body Image Scale (BIS), Hopwood, Fletcher, Lee & Ghazal (2001)
Appearance Schema Inventory Revised (ASI-R), Cash (2003)
Timepoint [1] 319429 0
1-month
Secondary outcome [2] 319430 0
Body image disturbance
Body Image Scale (BIS), Hopwood, Fletcher, Lee & Ghazal (2001)
Appearance Schema Inventory Revised (ASI-R), Cash (2003)
Timepoint [2] 319430 0
3-months
Secondary outcome [3] 319431 0
Psychological distress
Depression, Anxiety and Stress Scale (DASS21), Lovibond & Lovibond (1995)
Timepoint [3] 319431 0
1-week, 1-month, 3-months

Eligibility
Key inclusion criteria
Participants:
The study will be open to women who have completed active non-hormonal cancer treatment for breast cancer (surgery, chemotherapy and / or radiation). Participants may be still receiving follow up care and / or longer term hormonal treatments. Participants must be over the age of 18, have adequate command of the English language and computer skills. Participant recruitment will occur through the Breast Cancer Network Australia (BCNA), and other consumer organisation such as Breast Cancer WA and specialised lyphoedema services (Therapy for Life, Mt. Wilga Lymphoedema Clinic and the Macquarie University Hospital Physiotherapy Clinic) as required . The study will be advertised through the BCNA and related organisations, participants will self-select by responding to a website link contained in the advertisement.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Under age of 18
Insufficient written English skills
No access to an internet-linked computer
Lack of computer literacy
Still undergoing active breast cancer treatment

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 were allocated to their writing condition through central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is generated through the online questionnaire system Qualtrics.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
According to the study design, participants are divided into subgroups: Stream A (breast cancer only) and Stream B (breast cancer related lympheodema). The following estimates were used to recruit required participant numbers:

Stream A: 200 women diagnosed with breast cancer would be recruited, who will then be divided into two groups of 100 participants (control and experimental). Leary et al (2007) obtained an r-squared of .08 which is equivalent to Cohen's d of .58, this is regarded as a medium effect size. Using two conditions, samples of this size have been shown to be adequate for the purposes of research.

Stream B:100 women diagnosed with breast cancer-related lymphoedema would be divided into two groups of 50 participants (control and experimental). A priori calculation of the minimum required sample size given a probability level of 0.05, an anticipated effect size of .58 and 80% power is N=96 (n=48 per group).

Using these estimates a total N = 300 was considered adequate for the purposes of the study

Upon obtaining data from 300 participants, maximum likelihood linear mixed models will be applied to these data to assess change over time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/05/2015
Date of last participant enrolment
Anticipated
Actual
26/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
336
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292525 0
University
Name [1] 292525 0
Macquarie University
Country [1] 292525 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road, Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 291235 0
None
Name [1] 291235 0
None
Address [1] 291235 0
None
Country [1] 291235 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294000 0
Macquarie University Human Ethics Committee
Ethics committee address [1] 294000 0
Macquarie University
Balaclava Road, North Ryde NSW 2109
Ethics committee country [1] 294000 0
Australia
Date submitted for ethics approval [1] 294000 0
27/11/2014
Approval date [1] 294000 0
05/02/2015
Ethics approval number [1] 294000 0
Ref. 5201401083

Summary
Brief summary
The purpose of the study is to further understand women's experiences, regarding how they feel about themselves, their body, weight and appearance after completing treatment for breast cancer.

This study has two parts.

The first part is an on-line questionnaire to be filled in upon signing up for the study, with participants then undertaking follow up questionnaires one week, one month and 3 months after completing a writing activity. Participants will be asked about demographic information in the first questionnaire. Participants will also be asked about their current feelings and the impact of breast cancer or lymphoedema upon their body. It is expected that participants will need no more than 30 minutes to complete each on-line questionnaire.

The second part of the study involves doing a writing activity. Participants will be allocated to one of two writing groups (structured or unstructured writing formats). Participants will be asked to do an online writing exercise and will be asked to write about their unpleasant feelings and experiences during treatment for their cancer or lymphoedema as well as its impact upon their body. It is expected that this part will take about 30 minutes. This activity is completed anonymously, and participants will have the option to voluntarily submit their writing.
Trial website
Questionnaire link: https://mqedu.qualtrics.com/SE/?SID=SV_0CXQ1UhYUqnLky1

Writing activity links
Intervention: http://www.mychangedbody.org
Control: http://mqresearch.weebly.com
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 62066 0
A/Prof Kerry Sherman
Address 62066 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road
North Ryde NSW 2109
Country 62066 0
Australia
Phone 62066 0
+61298506874
Fax 62066 0
+61298508062
Email 62066 0
kerry.sherman@mq.edu.au
Contact person for public queries
Name 62067 0
A/Prof Kerry Sherman
Address 62067 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road
North Ryde NSW 2109
Country 62067 0
Australia
Phone 62067 0
+61298506874
Fax 62067 0
+61298508062
Email 62067 0
kerry.sherman@mq.edu.au
Contact person for scientific queries
Name 62068 0
A/Prof Kerry Sherman
Address 62068 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road
North Ryde NSW 2109
Country 62068 0
Australia
Phone 62068 0
+61298506874
Fax 62068 0
+61298508062
Email 62068 0
kerry.sherman@mq.edu.au

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
EmbaseReducing body image-related distress in women with breast cancer using a structured online writing exercise: Results from the my changed body randomized controlled trial.2018https://dx.doi.org/10.1200/JCO.2017.76.3318
N.B. These documents automatically identified may not have been verified by the study sponsor.