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Trial registered on ANZCTR


Registration number
ACTRN12621000953831
Ethics application status
Approved
Date submitted
7/06/2021
Date registered
21/07/2021
Date last updated
21/07/2021
Date data sharing statement initially provided
21/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of Body Appreciation on Female Cancer Survivors Body Image.
Scientific title
A randomised control trial comparing the efficacy of the Expand Your Horizons writing body appreciation intervention with a creative writing control in reducing body dissatisfaction and distress and increasing body appreciation and quality of life in adult female cancer survivors
Secondary ID [1] 304414 0
None
Universal Trial Number (UTN)
Trial acronym
EYH-Cancer
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 322217 0
Condition category
Condition code
Cancer 319912 319912 0 0
Any cancer
Mental Health 320282 320282 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ‘Expand Your Horizon’ (EYH) is a one-week long body appreciation-focused writing intervention. Participants will complete three writing tasks over the week period (days 1,4 and 7). Day one of the intervention will consist of pre-intervention measures and a fifteen-minute writing task with two writing prompts. Day four will consist of a fifteen-minute writing task with two writing prompts. Day seven will consist of fifteen-minute writing task with two writing prompts and post-intervention measures.

The body appreciation writing tasks encourage participants to focus on aspects of their body unrelated to physical appearance. The writing prompts in the intervention group were modified to reflect experiences cancer survivors may have ((eg.”Now, in your second writing assignment, you will focus only on body functions that are related to (1) health (e.g., fighting cancerous cells, breathing, or a continuously beating heart)”)). The intervention will be conducted online via Qualtrics, completed individually, and does not need a specific provider. However, participants will need access to a computer/tablet/phone and a personal email account. Each writing task link will be emailed to the participant.

Adherence to intervention will be analysed through the word count of each writing exercise.
Intervention code [1] 320772 0
Behaviour
Comparator / control treatment
The creative writing group will also complete three fifteen-minute online writing tasks over a week-long period (days 1, 4, and 7). The creative writing tasks ask the participant to create three different stories unrelated to body image over the three sessions. Each writing task will comprise of three questions: who is your main character, what is your setting, and what is your general plot. Once the participant has completed three questions, they will be prompted to start writing.
Control group
Active

Outcomes
Primary outcome [1] 327783 0
Change in body appreciation: the total score of Body Appreciation Scale-2.
Timepoint [1] 327783 0
Baseline / pre-treatment;
Post-treatment (7 days post baseline)
Secondary outcome [1] 396559 0
Change in body dissatisfaction: the total score of the Multidimensional Body-Self Relations Questionnaire – Appearance Subscales
Timepoint [1] 396559 0
Baseline / pre-treatment;
Post-treatment (7 days post baseline)
Secondary outcome [2] 396560 0
Change in distress: assessed using the Depression, Anxiety, and Stress Scale
Timepoint [2] 396560 0
Baseline / pre-treatment;
Post-treatment (7 days post baseline)
Secondary outcome [3] 396561 0
Change in mental and physical quality of life: assessed using the SF-12 Quality of Life Questionnaire
Timepoint [3] 396561 0
Baseline / pre-treatment;
Post-treatment (7 days post baseline)

Eligibility
Key inclusion criteria
1. Cancer Survivor treated with curative intent who has completed active anticancer treatments (i.e., not currently receiving chemotherapy, radiotherapy, surgery)
2. Female
3. Ages 18-65 years old
4. Sufficient English language literacy
5. Access to internet
6. Provide an active email address
Minimum age
18 Years
Maximum age
65 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
metastatic cancer (treated with palliative intent)

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)
The allocation is concealed until the interventions are assigned: this process will be automated within Qualtrics, therefore it is central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with stratification: A computer sequence generation algorithm in blocks to either ‘intervention’ or ‘creative writing control’, and each condition is assigned in random order within the block.
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size was calculated through the RMASS2: Repeated Measures with Attrition: Sample Sizes for 2 Groups, designed by Hedeker and Barlas. The sample size required for this study is 180 participants, which will allow for attrition.
Version 25 of IBM’s Statistical Package for Social Science (SPSS) will be used to clean and analyse the data. A Repeated Measures ANOVA will be used to examine the hypotheses that participants receiving the Expand Your Horizons intervention will improve body appreciation, body dissatisfaction, distress, and quality of life scores in comparison to the active control group. PROCESS will be used to examine they hypotheses that age difference will moderate the relationship between intervention and body image.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 308772 0
University
Name [1] 308772 0
Flinders University Student Project Awards 2021
Address [1] 308772 0
Sturt Road Bedford Park SA 5042
Country [1] 308772 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Road Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 309677 0
None
Name [1] 309677 0
n/a
Address [1] 309677 0
n/a
Country [1] 309677 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308687 0
Flinders Human Research Ethics Committee
Ethics committee address [1] 308687 0
Flinders University
GPO Box 2100
Adelaide SA 5001
Ethics committee country [1] 308687 0
Australia
Date submitted for ethics approval [1] 308687 0
17/05/2021
Approval date [1] 308687 0
12/07/2021
Ethics approval number [1] 308687 0

Summary
Brief summary
This study aims to investigate the impact of a body appreciation-based writing intervention on a female cancer survivor population.

Who is it for?
You may be eligible for this study if you are a female aged 18-65 who has completed active anticancer treatments (i.e. not currently receiving chemotherapy, radiotherapy, surgery), for any cancer type.

Study details
Participants will be randomly allocated by chance (similar to flipping a coin) to a one-week intervention with three 15-minute writing sessions which are either general creative writing or specifically based on body appreciation. Intervention measures will be taken directly before the first session and after the third session.

It is hoped that information from this study will help develop a program aimed at positive holistic wellbeing for female cancer survivors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111558 0
A/Prof Lisa Beatty
Address 111558 0
Flinders University
College of Education, Psychology & Social Work
GPO Box 2100
Adelaide SA 5001
Country 111558 0
Australia
Phone 111558 0
+61882012506
Fax 111558 0
Email 111558 0
lisa.beatty@flinders.edu.au
Contact person for public queries
Name 111559 0
A/Prof Lisa Beatty
Address 111559 0
Flinders University
College of Education, Psychology & Social Work
GPO Box 2100
Adelaide SA 5001
Country 111559 0
Australia
Phone 111559 0
+61882012506
Fax 111559 0
Email 111559 0
lisa.beatty@flinders.edu.au
Contact person for scientific queries
Name 111560 0
A/Prof Lisa Beatty
Address 111560 0
Flinders University
College of Education, Psychology & Social Work
GPO Box 2100
Adelaide SA 5001
Country 111560 0
Australia
Phone 111560 0
+61882012506
Fax 111560 0
Email 111560 0
lisa.beatty@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be available to protect participant confidentiality and anonymity, and we have not applied for ethics clearance to release this.
What supporting documents are/will be available?
No other documents available
Summary results
No Results