ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Breast Cancer

Body Image distress

Condition category

Condition code

Cancer

Breast

Mental Health

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]

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]

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]

3 month post baseline

Secondary outcome [1]

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]

1, 3 and 6 months post baseline

Secondary outcome [2]

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]

1, 3 and 6 months post baseline

Secondary outcome [3]

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]

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]

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]

1, 3 & 6 months post baseline

Secondary outcome [5]

Negative affect - The Positive and Negative Affect Schedule (PANAS) will be used to assess levels of negative affect (Watson, Clark, & Tellegen, 1988).

Timepoint [5]

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]

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]

6 months post baseline

Secondary outcome [7]

Timepoint [7]

1-month and 6-months post-baseline

Secondary outcome [8]

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]

1,3, and 6 months post-baseline

Secondary outcome [9]

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]

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

Sex

Females

Can healthy volunteers participate?

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

3/02/2020

Actual

17/03/2020

Date of last participant enrolment

Anticipated

1/10/2020

Actual

Date of last data collection

Anticipated

1/04/2021

Actual

Sample size

Target

225

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

All

Country [2]

Canada

State/province [2]

All

Country [3]

United Kingdom

State/province [3]

All

Country [4]

United States of America

State/province [4]

All

Funding & Sponsors

Funding source category [1]

University

Name [1]

Macquarie University

Address [1]

Dept of Psychology, Balaclava Rd, Macquarie Park NSW 2109

Country [1]

Australia

Primary sponsor type

University

Name

Macquarie University

Address

Balaclava Rd, Macquarie Park NSW 2109

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University HREC (Medical Sciences)

Ethics committee address [1]

Balaclava Road, North Ryde NSW 2109

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/09/2019

Approval date [1]

17/12/2019

Ethics approval number [1]

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

Prof Kerry Sherman

Address

Centre for Emotional Health, Department of Psychology, Balaclava Rd, Nth Ryde, Macquarie University NSW 2109

Country

Australia

Phone

+61 298506874

Fax

+61 298508062

[email protected]

Contact person for public queries

Name

Prof Kerry Sherman

Address

Centre for Emotional Health, Department of Psychology, Balaclava Rd, Nth Ryde, Macquarie University NSW 2109

Country

Australia

Phone

+61 298506874

Fax

+61 298508062

[email protected]

Contact person for scientific queries

Name

Prof Kerry Sherman

Address

Centre for Emotional Health, Department of Psychology, Balaclava Rd, Nth Ryde, Macquarie University NSW 2109

Country

Australia

Phone

+61 298506874

Fax

+61 298508062

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5142	Study protocol					378475-(Uploaded-29-09-2019-19-28-25)-Study-related document.pdf
5143	Informed consent form					378475-(Uploaded-27-11-2019-13-18-17)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4778	Study results article	Yes		09/05/2021	378475-(Uploaded-03-11-2021-16-44-55)-Journal results publication.pdf

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically