Trial Review

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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
28/10/2024
Date data sharing statement initially provided
21/07/2021
Date results provided
28/10/2024
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 writing control in increasing body appreciation and reducing body dissatisfaction and distress 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 single-session body appreciation-focused writing intervention. Participants will complete baseline / pre-intervention measures and visual analogue scales, followed immediately by the fifteen-minute writing task with writing prompts about 6 domains of body functionality. Immediately after completing the writing session, participants complete visual analogue scale measures of body appreciation, body dissatisfaction, and distress. One week later, participants complete post-intervention measures.

The body appreciation writing task encourages 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.”In your 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.

Adherence to intervention will be analysed through the word count of each writing exercise.
Intervention code [1] 320772 0
Behaviour
Comparator / control treatment
The control writing group will also complete a single fifteen-minute online writing task. The writing tasks ask the participant to describe yesterday’s activities in a factual manner.
Control group
Active

Outcomes
Primary outcome [1] 331636 0
Changes in functionality appreciation as measured by total scale score of the Functionality Appreciation Scale.
Timepoint [1] 331636 0
Baseline; Post-treatment (7-days post-baseline)
Secondary outcome [1] 396560 0
Change in distress: assessed using the Depression, Anxiety, and Stress Scale
Timepoint [1] 396560 0
Baseline / pre-treatment;
Post-treatment (7 days post baseline)
Secondary outcome [2] 410597 0
Changes in visual analogue state scale measure of functionality appreciation.
Timepoint [2] 410597 0
Baseline, immediately after completing the writing tasks.
Secondary outcome [3] 410598 0
Change in body appreciation: the total score of the Body Appreciation Scale-2-Short Form
Timepoint [3] 410598 0
Baseline / pre-treatment; post-treatment (7 days post-baseline)
Secondary outcome [4] 410599 0
Changes in visual analogue state scale measure of body appreciation
Timepoint [4] 410599 0
Baseline; Immediately after writing exercise
Secondary outcome [5] 410600 0
Changes in visual analogue state scale measure of body dissatisfaction
Timepoint [5] 410600 0
Baseline; Immediately after writing session
Secondary outcome [6] 410601 0
Changes in state distress, as measured by the Distress thermometer (single item visual analogue state scale measure of psychological distress)
Timepoint [6] 410601 0
Baseline; immediately after the writing session

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+ years old
4. Sufficient English language literacy
5. Access to internet
6. Provide an active email address
Minimum age
18 Years
Maximum age
No limit
Sex
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 ‘ 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. Linear Mixed Models will be used to examine the hypotheses that participants receiving the Expand Your Horizons intervention will improve body functionality, body appreciation, and distress in comparison to the active control group from baseline to 1-week post-intervention; and improve visual analogue measures of body functionality, appreciation, dissatisfaction and distress from pre- to post-writing. PROCESS will be used to examine they hypotheses that age difference will moderate the relationship between intervention and body image.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
30/07/2021
Actual
25/07/2021
Date of last participant enrolment
Anticipated
Actual
31/08/2022
Date of last data collection
Anticipated
31/12/2024
Actual
31/12/2022
Sample size
Target
180
Accrual to date
Final
65
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
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
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
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
[email protected]
Contact person for public queries
Name 111559 0
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
[email protected]
Contact person for scientific queries
Name 111560 0
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
[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
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 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.