Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001171303
Ethics application status
Approved
Date submitted
19/07/2017
Date registered
10/08/2017
Date last updated
31/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact on distress and self-compassion among women with cancer related lymphoedema following a writing exercise.
Scientific title
Does a writing intervention designed to enhance self-compassion and body image acceptance reduce psychological distress among women with cancer-related lymphoedema?
Secondary ID [1] 292440 0
none
Universal Trial Number (UTN)
N/A
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Cancer related lymphoedema 304052 0
Condition category
Condition code
Cancer 303375 303375 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The “My Changed Body” (MCB) intervention entails a writing exercise designed to enhance self-compassion. It assists an individual to develop self-warmth through personal and self-supportive disclosure.
PROCEDURE: To achieve this, the expressive writing exercise is structured in a way to mitigate the self-criticism associated with poor body image and this is achieved by the provision of 6 structured prompts that encourage the writer to be kind; to consider how they would support a friend in the same circumstances; and to look at their feelings from a broader perspective. The writing exercise will be provided online after the participant completed the questionnaire and read the general lymphoedema information (standard care). The writing exercise would take approximately 30 minutes and is only presented at baseline,
Intervention code [1] 298620 0
Behaviour
Intervention code [2] 298657 0
Treatment: Other
Comparator / control treatment
Control group will read general lymphoedema information as part of usual care. This information contains: general information about prevalence of lymphoedema, treatment options of lymphoedema, what you can do to minimise your risk of lymphoedema progression (e.g maintained weight, skin care), how to do deep breathing exercise and self-massage.
Control group
Active

Outcomes
Primary outcome [1] 302763 0
Primary outcome (1): Self-compassion, assessed using the Self Compassion Scale (SCS)
Timepoint [1] 302763 0
Timepoint (1) : 1 week post randomisation, 3 months post randomisation and 6months post randomisation.
Primary outcome [2] 303033 0
Primary outcome (2). Body image, assessed using Body Image Scale (BIS)
Timepoint [2] 303033 0
Timepoint (2): 1 week post randomisation, 3 months post randomisation and 6 months post randomisation
Primary outcome [3] 303034 0
Primary outcome (3) Body image appreciation or body appreciation will be measured with the Body Image Appreciation Scale (BIAS).
Timepoint [3] 303034 0
Timepoint (3) : 1 week post randomisation, 3 months post randomisation and 6 months post randomisation
Secondary outcome [1] 336933 0
Secondary outcome (1): Female sexual functioning as measured with the short Female Sexual Functioning Index
Timepoint [1] 336933 0
Timepoint secondary outcome (1): 6 months post randomisation
Secondary outcome [2] 337725 0
Primary outcome (4). To measure the negative emotional states of depression, anxiety and stress the Depression, Anxiety and Stress Scale will be used (DASS-21)
Timepoint [2] 337725 0
Timepoint (4): 1 week post randomisation, 3 months post randomisation and 6 months post randomisation.
Secondary outcome [3] 337726 0
Primary outcome (5): Positive and negative affects of the last 2 weeks will be assessed using the Positive and Negative Affect Scale (PANAS)
Timepoint [3] 337726 0
Timepoint (5): 1 week post randomisation

Eligibility
Key inclusion criteria
Females who have some concern (such as distress, body image disturbance, anxiety, depression) about their cancer related lymphoedema .
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
non-cancer related lymphoedema
under 18
no access to internet or email

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
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)
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
Available recruitment through support groups, lymphoedema therapists and the lymphoedema research unit in South Australia. We aim to recruit 150 females (75 participants in each group).
We will be using univariate (e.g ANOVA, T-Test) repeated measures and multivariate (e.g logistic regression) as appropriate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/07/2017
Date of last participant enrolment
Anticipated
1/03/2018
Actual
Date of last data collection
Anticipated
1/09/2018
Actual
Sample size
Target
150
Accrual to date
101
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA

Funding & Sponsors
Funding source category [1] 297006 0
University
Name [1] 297006 0
Flinders University. Faculty of Medicine, Nursing & Health Sciences - 2016 Competitive Research Grants
Country [1] 297006 0
Australia
Primary sponsor type
Individual
Name
Professor Carlene Wilson
Address
Chair, Cancer Prevention and Support (Behavioural Science),
Flinders Centre for Innovation in Cancer,
Flinders University of South Australia,
PO Box 2100, Adelaide, SA 5001
Country
Australia
Secondary sponsor category [1] 296045 0
None
Name [1] 296045 0
Address [1] 296045 0
Country [1] 296045 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298197 0
Social and Behaviour Research Ethics Committee
Ethics committee address [1] 298197 0
Research Services Office, Union Building Basement
Flinders University
Sturt Road, Bedford Park, South Australia 5042
Ethics committee country [1] 298197 0
Australia
Date submitted for ethics approval [1] 298197 0
03/04/2017
Approval date [1] 298197 0
02/06/2017
Ethics approval number [1] 298197 0
7638

Summary
Brief summary
The purpose of the proposed study is to evaluate whether a self-compassion-focused writing exercise, (“My Changed Body”), can decrease levels of distress among women with lymphoedema

Who is it for?
You may be eligible to join this study if you are a woman aged 18 years or over and have cancer related lymphoedema.

Study details
Study participants will be allocated by chance to one of the two groups. One group will receive general lymphoedema information as per usual care. This contains information about lymphoedema prevalence, reducing the risk, and self management strategies . The second group will receive a writing exercise. The writing exercise consists of 6 steps (total 30 minutes) with structured prompts that will encourage the writer to be kind; to consider how they would support a friend in the same circumstances; and to look at their feelings from a broader perspective

Study questionnaires will be completed up to six months past intervention completion to assess self-compassion and sexual functioning.
This is a significant project because lymphoedema is a prevalent side-effect of cancer treatment, is incurable and leads to concerning levels of psychological morbidity, which may be alleviated by a simple, low-cost writing exercise.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1898 1898 0 0
/AnzctrAttachments/373310-participant information sheet.pdf (Participant information/consent)

Contacts
Principal investigator
Name 76298 0
Prof Carlene Wilson
Address 76298 0
Chair, Cancer Prevention and Support (Behavioural Science), Flinders Centre for Innovation in Cancer, Flinders University of South Australia, PO Box 2100, Adelaide, SA 5001
Country 76298 0
Australia
Phone 76298 0
+61 3 9496 9967
Fax 76298 0
Email 76298 0
[email protected]
Contact person for public queries
Name 76299 0
Dr Malou van Zanten
Address 76299 0
Flinders Centre for Innovation in Cancer, Flinders University of South Australia, PO Box 2100, Adelaide, SA 5001
Country 76299 0
Australia
Phone 76299 0
+61 8 7421 9959
Fax 76299 0
Email 76299 0
[email protected]
Contact person for scientific queries
Name 76300 0
Prof Carlene Wilson
Address 76300 0
Chair, Cancer Prevention and Support (Behavioural Science), Flinders Centre for Innovation in Cancer, Flinders University of South Australia, PO Box 2100, Adelaide, SA 5001
Country 76300 0
Australia
Phone 76300 0
+61 3 9496 9967
Fax 76300 0
Email 76300 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.