Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000739617
Ethics application status
Approved
Date submitted
23/06/2023
Date registered
7/07/2023
Date last updated
27/10/2024
Date data sharing statement initially provided
7/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing two body image writing interventions for targeting positive body image in female cancer survivors
Scientific title
Comparing the effectiveness of two body image writing interventions against a neutral writing control in targeting positive body image in female cancer populations: A Randomised Controlled Trial
Secondary ID [1] 309937 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 330420 0
Condition category
Condition code
Mental Health 327255 327255 0 0
Other mental health disorders
Cancer 327378 327378 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The two interventions which will be examined include My Changed Body (Sherman et al., 208) and Expand Your Horizon (Alleva et al., 2016). In both intervention conditions, participants will spend up to 30 minutes completing a writing exercise.

In the My Changed Body intervention, participants will first be asked to recall and write about a distressing event following their cancer diagnosis. Next, participants will be guided by five self-compassionate prompts, which will first involve focusing on how their body has changed since their cancer diagnosis, before moving to a broad self-compassionate perspective in which they show kindness to their experience the same way they would to a friend in a similar situation. Participants will then write about ways in which other female cancer survivors may have similar experiences, before moving on to examine their feelings using a bigger perspective and putting space between the event and their reactions. Participants will finish the writing exercise by writing a self-compassionate letter to themselves. The intervention will consist of a single session of up to 30 minutes writing duration.

In the Expand Your Horizon condition, participants will be introduced to the concept of body functionality by reading a short description describing the meaning of body functionality, and by being provided with examples of different types of body functions. Participants will then be guided through the writing exercise by six writing prompts which will focus on different components of body functionality. Participants will be asked to reflect on and to write about the importance of each body function to them. Examples of relevant body functions will be provided for each writing prompt. The intervention will consist of a single session of up to 30 minutes writing duration.

The writing tasks’ content will also be analysed for this study to ensure participants are writing in accordance with the intervention instructions. In addition, the word count of each writing task will be captured to measure participant engagement.

The study will be conducted online using Qualtrics. As such, participants will be free to choose which location they wish to complete the study in.
Intervention code [1] 326361 0
Treatment: Other
Comparator / control treatment
Participants who are randomly allocated to the active control group will engage in a neutral writing exercise which will also be completed online via Qualtrics. Participants will be asked to spend up to 30 minutes writing about different rooms in their house as though they are describing it to someone who has never seen their house before. Participants will be guided through the exercise by six writing prompts, each of which will ask them to describe a different room (e.g., bedroom, lounge room, bathroom, kitchen...etc). Participants will be asked to be detailed as possible in their writing and to include information such as the size of each room, the number of windows, colour of furniture, and colour of walls. This neutral writing exercise follows that of Pennebaker and Beall (1986) whom asked participants to provide descriptions of their living rooms. However, for the purpose of ensuring consistency across intervention conditions, the writing exercise has been modified for the present study by asking participants to describe five additional rooms.
Control group
Active

Outcomes
Primary outcome [1] 335134 0
Trait Body Appreciation as measured by the Body Appreciation Scale-2 Short Form (BAS-2SF; Tylka et al., 2022)
Timepoint [1] 335134 0
Baseline, 1-week post intervention completion (primary time point), and 2-weeks post intervention completion
Primary outcome [2] 335135 0
State body appreciation will be measured using a state version of the Body Appreciation Scale-2 Short Form (BAS-2SF; Tylka et al., 2022). State body appreciation will be measured using 100 millimetre visual analogue scales with two anchor points (0=not at all, 100=very much). The wording of the BAS-2SF items will be adjusted to present tense in order to obtain a measure of state, rather than trait body image.
Timepoint [2] 335135 0
Immediately before writing intervention, immediately after writing intervention
Secondary outcome [1] 423216 0
Trait Functionality appreciation measured using the Functionality Appreciation Scale (FAS; Alleva et al., 2017)
Timepoint [1] 423216 0
Baseline, 1-week post intervention completion, 2-weeks post-intervention completion
Secondary outcome [2] 423217 0
Trait Distress measured using the 10-item Depression, Anxiety, and Stress Scale (DASS-10, Halford and Frost, 2021)
Timepoint [2] 423217 0
Baseline, 1-week post intervention completion, 2-weeks post intervention completion
Secondary outcome [3] 423219 0
Trait self-compassion measured using the Self-Compassion Scale Short-Form (Raes et al., 2011).
Timepoint [3] 423219 0
Baseline, 1-week post intervention, 2-weeks post-intervention
Secondary outcome [4] 423220 0
Trait body dissatisfaction measured using the Body Image Scale (Hopwood et al., 2001).
Timepoint [4] 423220 0
Baseline, 1-week post intervention, 2-weeks post-intervention
Secondary outcome [5] 423221 0
State functionality appreciation will be measured using 2 items selected from the Functionality Appreciation Scale (FAS; Alleva et al., 2017) using 100-millimetre visual analogue scales with two anchor points (0=not at all, 100=very much). The wording of the items will be changed to present tense to obtain a measure of state body image.
Timepoint [5] 423221 0
Immediately before writing intervention, immediately post writing intervention
Secondary outcome [6] 423222 0
State distress as measured using the distress thermometer (NCCN, 1997)
Timepoint [6] 423222 0
Immediately before writing intervention, immediately post writing intervention
Secondary outcome [7] 423223 0
State self-compassion measured using the state self-compassion scale short-form (SCS-SF; Neff et al., 2020)
Timepoint [7] 423223 0
Immediately before writing intervention, immediately post writing intervention
Secondary outcome [8] 423224 0
State body dissatisfaction will be measured using 3 items from the Body Image States Scale (BISS; Cash et al., 2002) using 100-millimetre visual analogue scales with two anchor points (0=not at all, 100=very much).
Timepoint [8] 423224 0
Immediately before writing intervention, immediately post writing intervention

Eligibility
Key inclusion criteria
Female cancer survivors 18 years and older with a previous or current cancer diagnosis, who are proficient in English, and who have access to the internet and a working email address.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence will be concealed from the researcher as it will be randomly generated by Qualtrics, which uses a randomizer sequence to assign participants to one of three conditions if they meet the eligibility criteria.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The Qualtrics randomiser will be enabled to ensure simple randomisation to intervention condition.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An a priori power analysis was conducted using G Power. An effect size of 0.5 was selected based on previous findings by Alleva et al. (2016). Parameters included 3 groups, 4 timepoints, significance level of 0.05, power level of 0.8, and 20% estimated attrition rates. Based on these parameters, 98 participants (n = 49 per group) will be needed to detect an effect. The study will utilise a quantitative based approach. Descriptive statistics will be used to describe the sociodemographic and clinical characteristics of the sample, and attrition rates. Chi square tests will be used to examine baseline differences between intervention groups (My Changed Body vs Expand Your Horizon) on categorical demographic variables such as cancer type and cancer treatment, and on completers versus drop-outs. Independent samples t-tests will be used to examine baseline differences on continuous variables (i.e., age and outcome variables). Linear mixed model analyses will be used to explore changes over time between the intervention groups on each outcome variable. Cohen’s d will be used to determine the strength of the intervention using between-group effect sizes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2023
Actual
30/09/2023
Date of last participant enrolment
Anticipated
16/08/2024
Actual
11/04/2024
Date of last data collection
Anticipated
30/08/2024
Actual
25/04/2024
Sample size
Target
98
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26655 0
New Zealand
State/province [1] 26655 0
Participants living in New Zealand could participate
Country [2] 26656 0
United Kingdom
State/province [2] 26656 0
Participants living in the United Kingdom could participate

Funding & Sponsors
Funding source category [1] 314117 0
University
Name [1] 314117 0
Flinders University
Country [1] 314117 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders University, Sturt Road Bedford Park SA 5042
College of Education, Psychology, and Social Work
Country
Australia
Secondary sponsor category [1] 316038 0
None
Name [1] 316038 0
Address [1] 316038 0
Country [1] 316038 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313254 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 313254 0
Ethics committee country [1] 313254 0
Australia
Date submitted for ethics approval [1] 313254 0
22/06/2023
Approval date [1] 313254 0
14/09/2023
Ethics approval number [1] 313254 0
6261

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127490 0
Miss Elizabeta Brkic
Address 127490 0
Flinders University, Sturt Rd, Bedford Park SA 5042
College of Education, Psychology, and Social Work
Country 127490 0
Australia
Phone 127490 0
+61 8 82013713
Fax 127490 0
Email 127490 0
[email protected]
Contact person for public queries
Name 127491 0
Lisa Beatty
Address 127491 0
Flinders University, Sturt Rd, Bedford Park SA 5042
College of Education, Psychology, and Social Work
Country 127491 0
Australia
Phone 127491 0
+610882012506
Fax 127491 0
Email 127491 0
[email protected]
Contact person for scientific queries
Name 127492 0
Lisa Beatty
Address 127492 0
Flinders University, Sturt Rd, Bedford Park SA 5042
College of Education, Psychology, and Social Work
Country 127492 0
Australia
Phone 127492 0
+610882012506
Fax 127492 0
Email 127492 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 shared due to being highly sensitive and easily identifiable data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19481Study protocol  [email protected]
19482Ethical approval  [email protected]



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.