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Trial registered on ANZCTR


Registration number
ACTRN12619000087156
Ethics application status
Approved
Date submitted
17/01/2019
Date registered
22/01/2019
Date last updated
19/09/2019
Date data sharing statement initially provided
22/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Brief online writing exercise to support individuals living with a stoma
Scientific title
Effect of expressive writing intervention on body image and quality of life in individuals with a stoma
Secondary ID [1] 297067 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Stoma 311096 0
Depression 311100 0
Anxiety 311156 0
Stress 311157 0
Condition category
Condition code
Oral and Gastrointestinal 309729 309729 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 309801 309801 0 0
Anxiety
Mental Health 309802 309802 0 0
Depression
Mental Health 309803 309803 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a brief, online expressive writing exercise (based on Pannebaker's expressive writing paradigm) accompanied by one online baseline and two follow-up questionnaires. This study is replicating a study that used self-compassion expressive writing to help reduce body-image distress in breast cancer survivors (Sherman et al., 2018). Before deciding to take part in the study, participants must read the Participant Information Sheet (PIS) and Consent Form. These will be available on our study web page (yet to be designed).

After consenting to the study, participants will complete an online baseline questionnaire that will take approx. 15 minutes to complete (though there is no time restriction). It will include demographic information and medical history related to their stoma, followed by questions on various psychological measures (body image, self-compassion, quality of life, depression/ anxiety/ stress, and disgust propensity and sensitivity. The questionnaire (and following writing exercise and follow-up questionnaires can be completed at a device/ computer of the participant's choice).

Participants (via REDCap software) will then be randomly allocated to either the intervention writing exercise (condition 1) or the control writing exercise (condition 2) and automatically sent a link to the appropriate exercise. Those in condition 1 will complete the online writing exercise by following six guided self-compassion prompts and write about a negative experience or event they have experienced (i.e. having their stoma constructed). he wording was modified slightly to be relevant to stoma patients (i.e. 'from 'Think about how your body has changed through the experience with a breast cancer diagnosis and treatment' to 'Think about how your body has changed through your experience with having your stoma constructed'). Those in condition 2 will also have prompts to write about a negative event, but these will be generic (i.e. 'Please describe the event further'). Both writing exercises will take up to 30 minutes to complete (depending on participants' typing speed, time spent considering what to write). There is no restriction/ limit on how many words/ characters participants must write.

Participants will then be sent follow-up questionnaires (a shortened version of the baseline questionnaire; should take 10 mins max.) one week and one month following the writing exercise. These will also be completed online. The Disgust Propensity and Sensitivity Scale items will not be included in the follow-up questionnaires.

Intervention code [1] 313362 0
Lifestyle
Intervention code [2] 313394 0
Behaviour
Comparator / control treatment
The control (i.e. placebo) writing condition will be similar to the intervention writing condition in that it will have prompts to guide the participants with writing. However, the control group prompts will be generic and the same each time, rather than differing prompts based on the different aspects of self-compassion (what those in the intervention condition will receive).
Control group
Placebo

Outcomes
Primary outcome [1] 318695 0
Change in average body image scores (from Body Image Scale)
Timepoint [1] 318695 0
Measured at all time points (baseline, one week and one month following writing exercise
Primary outcome [2] 318705 0
Change in average quality of life scores (from Stoma-QOL scale)
Timepoint [2] 318705 0
Measured at all time points (baseline, one week and one month following writing exercise
Secondary outcome [1] 365779 0
Change in average self-compassion scores (from SCS-SF)
Timepoint [1] 365779 0
Measured at all time points (baseline, one week and one month following writing exercise
Secondary outcome [2] 365780 0
Change in depression scores (from DASS scale)
Timepoint [2] 365780 0
Measured at all time points (baseline, one week and one month following writing exercise)
Secondary outcome [3] 365861 0
Change in anxiety scores (from DASS scale)
Timepoint [3] 365861 0
Measured at all time points (baseline, one week and one month following writing exercise)
Secondary outcome [4] 365862 0
Change in stress scores (from the DASS)
Timepoint [4] 365862 0
Measured at all time points (baseline, one week and one month following writing exercise)

Eligibility
Key inclusion criteria
- 18+ years
- Fluent in English (reading and writing)
- Stoma for at least the duration of the study
- Live in New Zealand or Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Younger than 18 years of age
- Cannot fluently write and read in English
- Stoma for less than the duration of the study

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)
Central randomisation by computer software (REDCap)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Stratified allocation by gender
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
Power analysis repeated measures within-between MANOVA with 2 groups x 3 measures. Power = .80 and error = .05, and moderate effect size p=.03 N=111. Including an estimated 15% attrition based on the findings of another study this study will replicate, the sample size needed = 130 participants.

Analyse using SPSS. Repeated measures 2 x 3 MANOVA. Comparing 2 conditions (between) across 3 time points (within).
Disgust Propensity and Sensitivity Scale scores (DPSS) will be measured only at baseline and will be analysed as a moderator.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2019
Actual
9/05/2019
Date of last participant enrolment
Anticipated
1/08/2019
Actual
29/06/2019
Date of last data collection
Anticipated
Actual
31/07/2019
Sample size
Target
130
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21206 0
New Zealand
State/province [1] 21206 0
Whole country

Funding & Sponsors
Funding source category [1] 301638 0
University
Name [1] 301638 0
University of Auckland
Country [1] 301638 0
New Zealand
Primary sponsor type
Individual
Name
Dr. Lisa Reynolds
Address
Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 301345 0
Individual
Name [1] 301345 0
Lauren Harris
Address [1] 301345 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country [1] 301345 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302361 0
The University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 302361 0
The University of Auckland,
Office of Research Strategy and Integrity,
Private Bag 92019,
Auckland 1142
Ethics committee country [1] 302361 0
New Zealand
Date submitted for ethics approval [1] 302361 0
14/01/2019
Approval date [1] 302361 0
20/03/2019
Ethics approval number [1] 302361 0

Summary
Brief summary
The primary purpose of this study is to investigate the effects a brief, one-off writing exercise can have on the psychological outcomes of individuals living with a stoma. The study design is a mixed analysis of variances (MANOVA) comparing 2 groups (intervention and control condition) across 3 time points (baseline, one week and one month following the writing exercise). It is hypothesised that those in the intervention condition will see statistically significant improvements in a range of psychological outcomes, and more so in comparison to those in the control condition.
Trial website
lhar855.wixsite.com/supportivestoma
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89958 0
Dr Lisa Reynolds
Address 89958 0
Department of Psychological Medicine
Level 12, Room 12.101
Support Building
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023, New Zealand
Country 89958 0
New Zealand
Phone 89958 0
+64 (0) 9 923 6531
Fax 89958 0
Email 89958 0
[email protected]
Contact person for public queries
Name 89959 0
Lisa Reynolds
Address 89959 0
Department of Psychological Medicine
Level 12, Room 12.101
Support Building
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023, New Zealand
Country 89959 0
New Zealand
Phone 89959 0
+64 (0) 9 923 6531
Fax 89959 0
Email 89959 0
[email protected]
Contact person for scientific queries
Name 89960 0
Lisa Reynolds
Address 89960 0
Department of Psychological Medicine
Level 12, Room 12.101
Support Building
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023, New Zealand
Country 89960 0
New Zealand
Phone 89960 0
+64 (0) 9 923 6531
Fax 89960 0
Email 89960 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All participant contact information and their responses to the writing exercise and questionnaires will be kept confidential and securely stored on the University databases. No data will be shared that could identify individual participants.


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.