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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]

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

Condition category

Condition code

Cancer

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]

Behaviour

Intervention code [2]

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]

Primary outcome (1): Self-compassion, assessed using the Self Compassion Scale (SCS)

Timepoint [1]

Timepoint (1) : 1 week post randomisation, 3 months post randomisation and 6months post randomisation.

Primary outcome [2]

Primary outcome (2). Body image, assessed using Body Image Scale (BIS)

Timepoint [2]

Timepoint (2): 1 week post randomisation, 3 months post randomisation and 6 months post randomisation

Primary outcome [3]

Primary outcome (3) Body image appreciation or body appreciation will be measured with the Body Image Appreciation Scale (BIAS).

Timepoint [3]

Timepoint (3) : 1 week post randomisation, 3 months post randomisation and 6 months post randomisation

Secondary outcome [1]

Secondary outcome (1): Female sexual functioning as measured with the short Female Sexual Functioning Index

Timepoint [1]

Timepoint secondary outcome (1): 6 months post randomisation

Secondary outcome [2]

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]

Timepoint (4): 1 week post randomisation, 3 months post randomisation and 6 months post randomisation.

Secondary outcome [3]

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]

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?

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]

University

Name [1]

Flinders University. Faculty of Medicine, Nursing & Health Sciences - 2016 Competitive Research Grants

Address [1]

Flinders University of South Australia,
PO Box 2100, Adelaide, SA 5001

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Social and Behaviour Research Ethics Committee

Ethics committee address [1]

Research Services Office, Union Building Basement
Flinders University
Sturt Road, Bedford Park,  South Australia 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/04/2017

Approval date [1]

02/06/2017

Ethics approval number [1]

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]

/AnzctrAttachments/373310-participant information sheet.pdf (Participant information/consent)

Contacts

Principal investigator

Name

Prof 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

Phone

+61 3 9496 9967

Fax

carlene.wilson@flinders.edu.au

Contact person for public queries

Name

Malou van Zanten

Address

Flinders Centre for Innovation in Cancer, Flinders University of South Australia, PO Box 2100, Adelaide, SA 5001

Country

Australia

Phone

+61 8 7421 9959

Fax

malou.vanzanten@flinders.edu.au

Contact person for scientific queries

Name

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

Phone

+61 3 9496 9967

Fax

carlene.wilson@flinders.edu.au

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.

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