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Trial registered on ANZCTR


Registration number
ACTRN12619001693112
Ethics application status
Approved
Date submitted
29/10/2019
Date registered
2/12/2019
Date last updated
7/07/2020
Date data sharing statement initially provided
2/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Kind to my Body: A study of feelings towards your body in women with Breast Cancer
Scientific title
A Randomised Control Trial of a Self-Compassion Writing and Meditation Intervention to assess effect on Body Image Distress in Women with Breast Cancer
Secondary ID [1] 299433 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 314627 0
Body Image distress 314628 0
Condition category
Condition code
Cancer 312965 312965 0 0
Breast
Mental Health 313562 313562 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project design is a three-group blind randomised controlled designed with two intervention groups:
• Group 1: My Changed Body Writing (MyCB)
• Group 2: My Changed Body Writing plus meditation (MyCB + Meditation)

All writing activities and study questionnaires will be completed online via the secure Qualtrics portal run through Macquarie University with no direction from personnel. Meditations will be downloadable from the Qualtrics portal and via participant emails (for those in group 2 only).

The My Changed Body is an evidence-based web-based writing intervention designed to address body image concerns arising from breast cancer surgery and treatment (Sherman et al., 2018). Participants in both of the MyCB writing condition will complete the condition over two sessions, directly following the baseline and 1 month survey. Participant reminder emails will be sent to ensure adherance.

The first session will be conducted directly after completing the baseline questionnaires and entails the complete MyCB activity, which is a self-paced writing activity that is estimated to take approximately 30 min to complete. Six writing prompts are provided: (1) an introductory unstructured writing section where individuals write about a negative body image experience according to a modified Pennebaker (Pennebaker & Seagal, 1999) writing prompt; (2) treatment of one’s body with kindness; (3) kind advice to oneself; (4) connection with others who experience difficulties with body image; (5) awareness of one’s circumstances and reactions in a broader context; and, (6) a self-compassionate letter to the writer that acts as a summary of the most salient points of self-compassion as applied to one’s own situation. Thus, the intervention user addresses self-kindness, common humanity and mindful awareness, as outlined by self-compassion research.

The second session will be conducted directly following the 1-month follow-up questionnaires and entail participants completing a brief version of the MyCB writing activity, which will take approximately 10min. Participants will be asked to repeat only step 6 of the writing process, which is to write a self-compassionate letter to themselves.

In addition to the protocol outlined above for Group #1 Intervention, participants in Group #2 will complete meditations over two-time periods.
Firstly, following the final baseline questionnaires, participants will be provided a link to download an audio file of a self-compassion based meditation. The meditation will also be emailed to their nominated account. The 5 minute meditation can be saved to the mobile or digital device. Participants will be instructed to listen to the meditation either sitting or laying down, in a quiet and uninterrupted space, each day, for the following three weeks. To maximise compliance, participants will receive a daily SMS reminder to listen to the audio recording.
Upon completion of the 1-month questionnaires and MyCB writing activity, participants will be asked to listen to the same meditation either sitting or lying down, in a quiet and uninterrupted space, each day, for the following three weeks. To maximise compliance, participants will receive a daily SMS reminder to listen to the audio recording.
Intervention code [1] 315687 0
Treatment: Other
Comparator / control treatment
Group 3: Expressive Writing active control (EW)
All writing activities and study questionnaires will be completed online via the secure Qualtrics portal run through Macquarie University. Participants allocated to the active control will be asked to write about their challenging experience over two sessions. The control condition will be consistent in structure and duration taken to complete the MyCB writing exercise. This form of Control has been used successfully in prior trials of the MyCB intervention (Sherman et al., 2018).
At baseline, following the questionnaires, participants in the control condition will be asked to write about a challenging body image experience in the same way as the first step of the MyCB Intervention participants. It entails a self-paced writing activity, with prompts, that is estimated to take approximately 30 min to complete. Six writing prompts are provided: (1) an introductory unstructured writing section where individuals write about a negative body image experience according to a modified Pennebaker (Pennebaker & Seagal, 1999) and prompts (2) to (6) ask participants to continue exploring their experience, including event details, thoughts and feelings.
The second session will be conducted directly following the 1-month follow-up questionnaires and entail participants completing a brief version of the writing activity, whereby they write about a challenging body image experience in as much detail as possible and will be approximately 10min in duration.
Control group
Active

Outcomes
Primary outcome [1] 321547 0
Body Image - The Body Image Scale (BIS) measures body image disturbance (negative aspects of body image) and was developed for use with oncology populations (Hopwood, Fletcher, Lee, & Al Ghazal, 2001). It consists of 10 items to measure body image distress, including aspects of affect, behaviour and cognition.
Timepoint [1] 321547 0
3 month post baseline
Secondary outcome [1] 375331 0
The Body Image Appreciation Scale (BAS) assesses positive aspects of body image and was developed to assess body image (Tylka & Wood- Barcalow, 2015a, 2015b). Higher scores indicate higher body appreciation.(Avalos, Tylka, & Wood-Barcalow, 2005).
Timepoint [1] 375331 0
1, 3 and 6 months post baseline
Secondary outcome [2] 375332 0
Self-Compassion - The short form of the Self Compassion Scale (SCS) measures compassion towards the self, as rated by the participant using 12 items (Costa, Maroco, Pinto-Gouveia, Ferreira, & Castilho, 2015; Raes, Pommier, Neff, & Van Gucht, 2011).
Timepoint [2] 375332 0
1, 3 and 6 months post baseline
Secondary outcome [3] 375333 0
Self Compassion - Body Focused Self-Compassionate Mindset (BFSCM) will be used to assess participants’ state levels of self-compassionate regarding their body, constructed from the suggested body self-compassion sub-domain proposed by Berry et al., (2010).
Timepoint [3] 375333 0
Immediately following the 1st writing activity that is undertaken after completion of the Baseline survey for all groups. This is labelled as "Post-intervention".
Secondary outcome [4] 375334 0
Cancer-specific Psychological distress as reflected by the Impact of Event Scale - Revised (IES-R) is a 22 item instrument used to measure responses of avoidance, intrusion and hyper-arousal (Creamer, Bell, & Failla, 2003).
Timepoint [4] 375334 0
1, 3 & 6 months post baseline
Secondary outcome [5] 375335 0
Negative affect - The Positive and Negative Affect Schedule (PANAS) will be used to assess levels of negative affect (Watson, Clark, & Tellegen, 1988).
Timepoint [5] 375335 0
Immediately following the 1st writing activity that is undertaken after completion of the Baseline survey for all groups. This is labelled as "Post-intervention".
Secondary outcome [6] 375336 0
Quality of Life – EQ-5D-3L is a EuroQol Research Foundation instrument measuring health related quality of life. This measure will be used to monitor health status of participants over time.
Timepoint [6] 375336 0
6 months post baseline
Secondary outcome [7] 376361 0
Body Image - The Body Image Scale (BIS) measures body image disturbance (negative aspects of body image) and was developed for use with oncology populations (Hopwood, Fletcher, Lee, & Al Ghazal, 2001). It consists of 10 items to measure body image distress, including aspects of affect, behaviour and cognition.
Timepoint [7] 376361 0
1-month and 6-months post-baseline
Secondary outcome [8] 376363 0
Psychological distress – The Depression, Anxiety and Stress Scales (DASS 21) is a short version of the full DASS scale (Gloster et al., 2008; J. D. Henry & Crawford, 2005; Osman et al., 2012; Ronk, Korman, Hooke, & Page,
2013).
Timepoint [8] 376363 0
1,3, and 6 months post-baseline
Secondary outcome [9] 376365 0
Emotional Dysregulation – State Difficulties in Emotion Regulation Scale (S-DERS) is a 21- item state-based measure of emotion dysregulation. (Lavender, Tull, DiLillo, Messman-Moore, & Gratz, 2017).
Timepoint [9] 376365 0
1, 3, and 6 months post-baseline

Eligibility
Key inclusion criteria
Participants are eligible to participate if they self identify as the following: over 18 years of age; Previously diagnosed with Stage I-III breast cancer and/or ductal
carcinoma in-situ within the last 2 years; and undergone breast cancer-related surgery within the last 2 years; Willing to undertake a writing exercise online (in any language); Experienced at least one negative event related to the changes that have occurred to the woman’s body after breast cancer (i.e., an event that has
made them feel embarrassed, sad, angry, etc)
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previously participated in a study utilising the My Changed Body writing intervention

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The intervention will be administered entirely online so randomisation will occur online. Participants were informed that they would take part in a writing exercise. Concealment will be by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Qualtrics randomiser function will be used to randomise participants following the completion of the online baseline-survey.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Active control group using an expressive writing task, so that time and the effect of writing can be accounted for.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Initial descriptive analyses of demographic and medical characteristics and bivariate associations of these variables with the study outcomes will be undertaken to identify possible covariates using Pearson’s correlation (continuous variables) and chi-square analyses (categorical variables).
Main analysis will be based on a group (three conditions) by time (four assessments: baseline, baseline post intervention, 1 month, 3 month and 6 month follow-up) randomised trial with an intent-to-treat approach. Maximum-likelihood linear mixed models will be used to test group, time, and group-time interactions effects for all independent variables.
Maximum likelihood estimation, which assumes that data is missing at random, will be utilised to manage missing data. Random effects for a participant-specific random intercept will account for within-participant correlation. Cohen’s d will be used as a measure of effect size for each outcome. All analyses will use the standard alpha level of 0.05 and will be carried out using SPSS.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 22722 0
New Zealand
State/province [1] 22722 0
All
Country [2] 22723 0
Canada
State/province [2] 22723 0
All
Country [3] 22724 0
United Kingdom
State/province [3] 22724 0
All
Country [4] 22725 0
United States of America
State/province [4] 22725 0
All

Funding & Sponsors
Funding source category [1] 303943 0
University
Name [1] 303943 0
Macquarie University
Address [1] 303943 0
Dept of Psychology, Balaclava Rd, Macquarie Park NSW 2109
Country [1] 303943 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 304102 0
None
Name [1] 304102 0
Address [1] 304102 0
Country [1] 304102 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304442 0
Macquarie University HREC (Medical Sciences)
Ethics committee address [1] 304442 0
Balaclava Road, North Ryde NSW 2109
Ethics committee country [1] 304442 0
Australia
Date submitted for ethics approval [1] 304442 0
19/09/2019
Approval date [1] 304442 0
17/12/2019
Ethics approval number [1] 304442 0
52019580812723

Summary
Brief summary
The purpose of the study is to evaluate whether a brief self-compassion based writing exercise, known as 'My Changed Body' (MyCB), can alleviate body image distress (BID) in women recently diagnosed with breast cancer, over and above and expressive writing alone.

Who is it for?
You may be eligible to join this study if you are aged 18 years or older and have been previously diagnosed with Stage I-III breast cancer and/or ductal
carcinoma in-situ and undergone breast cancer-related surgery within the last 2 years

Study details
All participants will be randomly assigned (by chance) to one of three groups. One intervention group will focus on an online writing tool only, i.e 'MyCb', where participants will focus on self-compassion strategies over two writing sessions. The second intervention will also involve the MyCB writing tool plus a daily meditation component. The third group (control) will participate in an expressive writing activity. All participants will be asked to complete questionnaires about their body image.

It is anticipated that MyCB plus meditation intervention can reduce body image distress and assist in maintaining a positive self image for longer. In addition, we hope to provide greater insight into psychological strategies that may help women with breast cancer.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96958 0
Prof Kerry Sherman
Address 96958 0
Centre for Emotional Health, Department of Psychology, Balaclava Rd, Nth Ryde, Macquarie University NSW 2109
Country 96958 0
Australia
Phone 96958 0
+61 298506874
Fax 96958 0
+61 298508062
Email 96958 0
kerry.sherman@mq.edu.au
Contact person for public queries
Name 96959 0
Prof Kerry Sherman
Address 96959 0
Centre for Emotional Health, Department of Psychology, Balaclava Rd, Nth Ryde, Macquarie University NSW 2109
Country 96959 0
Australia
Phone 96959 0
+61 298506874
Fax 96959 0
+61 298508062
Email 96959 0
kerry.sherman@mq.edu.au
Contact person for scientific queries
Name 96960 0
Prof Kerry Sherman
Address 96960 0
Centre for Emotional Health, Department of Psychology, Balaclava Rd, Nth Ryde, Macquarie University NSW 2109
Country 96960 0
Australia
Phone 96960 0
+61 298506874
Fax 96960 0
+61 298508062
Email 96960 0
kerry.sherman@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not sought ethics approval for any individual data to be made publicly available. Rather, only deidentified group/combined data will be available at any stage.
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 5142 0
Study protocol
Citation [1] 5142 0
Link [1] 5142 0
Email [1] 5142 0
Other [1] 5142 0
Type [2] 5143 0
Informed consent form
Citation [2] 5143 0
Link [2] 5143 0
Email [2] 5143 0
Other [2] 5143 0
Summary results
No Results