Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000783729
Ethics application status
Approved
Date submitted
16/06/2013
Date registered
15/07/2013
Date last updated
14/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Self-compassionate writing for breast cancer survivors
Scientific title
The effect of writing according to self-compassionate prompts on breast cancer patients' affect and mindset.
Secondary ID [1] 282432 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 289121 0
Psychological distress 289122 0
Self-compassion 289123 0
Condition category
Condition code
Cancer 289459 289459 0 0
Breast
Mental Health 289460 289460 0 0
Other mental health disorders
Mental Health 289461 289461 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aims of project
To assess whether affect and mindset can be modified in the short term through a self-compassionate writing activity focused on body image.

Plan and method
Part One
There are two parts to this research. The first part of the research involves completion of an online questionnaire package to collect background data. This should take about 20 minutes and is conducted in the convenience of the participant’s home.
From this point participants will be randomised by the researcher into two groups (control and experimental) using the www.randomizer.org program.

Part Two
The second part involves a writing exercise and completion of a paper-based questionnaire which will be sent via mail.

All participants will complete a brief pre-writing questionnaire (envelope 1)

After this participants will open another envelope (envelope 2) with a set of instructions and writing paper. Participants in the control condition will receive instructions for unstructured descriptive writing regarding body image after treatment. They will be asked to write for a total of 4 pages with general writing guidelines (ie use of introduction, body, conclusion) but will receive no additional prompts or structure to their writing.

Participants in the experimental condition will also engage in writing however using additional prompts designed to encourage a compassionate orientation to the self, modelled after the procedures of Leary et al (2007). Participants will be asked to write a response to each self-compassion prompt, comprising a total of 4 pages. These prompts are designed to elicit attitudes of self-kindness, mindfulness and feelings of common humanity and are based on the definition of self-compassion provided by Neff (2003).

Immediately after completion of writing participants will be asked complete a post writing questionnaire that rates their affect using Likert scales as per Leary et al (2007). Participants will also complete an additional rating scale created to measure self-compassionate mindset. This entire package will be sent via post and a reply paid envelope will be provided for the return of pre & post writing questionnaires.

Participants will be given the option of keeping their writing exercise or sending it in with their questionnaire responses. This will be entirely according to the participants preference.

This part should take approximately 45 minutes in total and is undertaken in the convenience of the participant’s home.

Measures:

The Body Image Scale (BIS) was developed by Hopwood, Fletcher, Lee & Ghazal (2001) for use with oncology populations. It consists of 10 items to measure body image distress, including aspects of affect, behaviour and cognition. This scale shows high reliability (Cronbach’s alpha 0.93) and good clinical validity and sensitivity to change. The BIS has been widely cited by researchers in the oncology field (eg. Harcourt et al, 2003, Garry et al, 2004)

The Self Compassion Scale (SCS) measures compassion towards the self, as rated by the participant. Twenty-six Likert scale items include a series of six sub-scales to assess self compassion using a total score. The SCS has been assessed to have good test-retest reliability (a=0.93) and validity, (Neff, 2003).

The Depression, Anxiety and Stress Scale (DASS 21) is a short version of the full 42 item DASS scale developed by Lovibond & Lovibond (1995). The DASS 21 comprises 21 items (with three subscales, 7 items each) to measure respondent’s levels of depression, anxiety and stress. This instrument has been found to have satisfactory validity and reliability, and have higher user acceptability, (Henry and Crawford, 2005).

The Body Image Appreciation Scale (BAS) was developed to assess body image. Higher scores indicate higher body appreciation. This scale has acceptable psychometric properties with item consistency of .94 for the scale and demonstrated construct validity (Avalos, Tylka & Wood-Baraclow, 2005).

It is expected that the at home writing exercise and questionnaire completion will take no more than 45 minutes of participant time in total.

Data collection and storage:
Data collected will be stored in a password protected folder. Participant emails and data obtained will be stored separately and emails will not be linked to data. Only the study investigator and supervisors will have access to research data. All patient information obtained for the study will be de-identified before publication and dissemination of results.
Intervention code [1] 287139 0
Behaviour
Comparator / control treatment
Participants will receive instructions for unstructured descriptive writing regarding body image after treatment. They will be asked to continue for 4 pages duration with general writing guidelines (ie use of introduction, body, conclusion) but will receive no additional prompts or structure to their writing.
Control group
Active

Outcomes
Primary outcome [1] 289565 0
Total affect was measured by 16 Likert-type items previously utilized in self-compassion interventions (Leary, 2007), where participants rated how they currently felt (1=not at all to 7=extremely). Emotions assessed included happiness (happy, cheerful, delighted, pleased), sadness (down, depressed, sad, dejected), anger (irritated, annoyed, mad, angry) and anxiety (anxious, tense, uneasy, nervous). Scores for the positive affect items were reversed, and total scores for each subs-scale obtained, with higher scores indicating greater negative affect . Total affect score is thus a combination of positive (reversed) and negative affect scores.
Timepoint [1] 289565 0
immediately pre and post writing activity
Primary outcome [2] 289567 0
Compassionate mindset questions were constructed from factors used in measurement of self-compassion (Neff 2003) and adapted for the purposes of this study to measure short term changes arising from the writing activity.This was assessed by six Likert items using the same format as the Affective response items. These items were based on components of kindness, mindfulness, common humanity and attitude towards one's body.
Timepoint [2] 289567 0
immediately pre and post writing activity
Secondary outcome [1] 302747 0
NIL
Timepoint [1] 302747 0
NIL

Eligibility
Key inclusion criteria
Prior diagnosis of breast cancer
Completion of active non hormonal treatment
Over 18 years of age
Level of written English that allows completion of online and paper based questionnaires, as well as writing activity
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No prior breast diagnosis
Still undergoing active breast cancer treatment
Under 18 years
Level of English that does not allow participant to comfortably complete questionnaires or writing activity

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 approached through consumer organisations and invitations will be emailed to members asking whether they wish to join the study. No direct recruitment contact will be made with potential participants. Allocation to conditions does not involve the recruiting sites in any way, as entry into the study is voluntary and self-directed from individuals identifying as meeting the eligibility criteria. Once recruited and consented into the study, participants are randomly allocated to the specific conditions by the investigators. The experimental and control conditions will be allocated through the use of a computer program (randomizer.org) to generate allocation sequence. Thus, from the investigator perspective the allocation to conditions is not concealed, but it is concealed from the recruiting organisations and from participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
www.randomizer.org will be used to generate sequence of subject allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
A pre and post test design will be used as part of the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mancova analysis will be employed with the collected data to test the effect of writing according to compassionate prompts versus not having these prompts. No previous study exists using self-compassion writing interventions in cancer populations, so sample estimates were based on Leary (2007) who used a general population for his research. Leary obtained an r-squared of .08 which is equivalent to a Cohen's d of .58 (medium effect size). With this is mind, use of 100 participants, divided into two groups of 50 is considered adequate for this purposes of this research.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2012
Actual
27/08/2012
Date of last participant enrolment
Anticipated
1/07/2013
Actual
16/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA

Funding & Sponsors
Funding source category [1] 287270 0
University
Name [1] 287270 0
Macquarie University
Country [1] 287270 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, Ryde, NSW 2109
Country
Australia
Secondary sponsor category [1] 286023 0
None
Name [1] 286023 0
Address [1] 286023 0
Country [1] 286023 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289250 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 289250 0
Ethics committee country [1] 289250 0
Australia
Date submitted for ethics approval [1] 289250 0
08/06/2012
Approval date [1] 289250 0
03/07/2012
Ethics approval number [1] 289250 0
Ref: 5201200298

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

Contacts
Principal investigator
Name 39738 0
Dr Kerry Sherman
Address 39738 0
Department of Psychology
Macquarie University
North Ryde
NSW 2109
Country 39738 0
Australia
Phone 39738 0
+6129850-6874
Fax 39738 0
Email 39738 0
[email protected]
Contact person for public queries
Name 39739 0
Kerry Sherman
Address 39739 0
Department of Psychology
Macquarie University
North Ryde
NSW 2109
Country 39739 0
Australia
Phone 39739 0
+6129850-6874
Fax 39739 0
Email 39739 0
[email protected]
Contact person for scientific queries
Name 39740 0
Kerry Sherman
Address 39740 0
Department of Psychology
Macquarie University
North Ryde
NSW 2109
Country 39740 0
Australia
Phone 39740 0
+6129850-6874
Fax 39740 0
Email 39740 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
No additional documents have been identified.