Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001642875
Ethics application status
Approved
Date submitted
4/11/2021
Date registered
30/11/2021
Date last updated
7/12/2022
Date data sharing statement initially provided
30/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
EndoSMS: A text message supportive program for individuals with endometriosis
Scientific title
EndoSMS: Development and feasibility study of a text-based supportive intervention for individuals with endometriosis
Secondary ID [1] 305723 0
Nil
Universal Trial Number (UTN)
Trial acronym
EndoSMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 324196 0
Quality of Life 324197 0
Psychological distress 326473 0
Condition category
Condition code
Reproductive Health and Childbirth 321682 321682 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EndoSMS is a text messaged based intervention that provides supportive messages to individuals living with endometriosis. Messaging covers a range of domains including general endometriosis information, psychological support, self-care and general lifestyle tips. Participants will receive four semi-personalised text messages (e.g., to their preferred name) per week, free of charge, for a period of three months with messages selected from the EndoSMS message bank according to their user characteristics (e.g., smoker vs. non-smoker). Each message is very brief - a maximum of 50 characters and should take less than 1 minute to read.
Intervention code [1] 322116 0
Behaviour
Comparator / control treatment
Participants randomised to the waitlist control condition will receive no additional support beyond their usual care (e.g., GP/gynaecologist appointments) until the pilot is complete at 3 months and then they will be given the option to receive the text messaging program for a period of 3 months
Control group
Active

Outcomes
Primary outcome [1] 329449 0
Endometriosis-specific quality of life assessed with the reliable and valid Endometriosis Health Profile Questionnaire-30 (EHP-30; Jones et al., 2006)
Timepoint [1] 329449 0
3 months post baseline
Primary outcome [2] 331491 0
Emotional health measured using the widely used and validated short-version of the original DASS, the Depression, Anxiety and Stress Scales 21 item (DASS-21; Lovibond & Lovibond
Timepoint [2] 331491 0
3 months post baseline
Secondary outcome [1] 402654 0
Self-efficacy for managing endometriosis symptoms, daily activities, medication/treatment and social interactions, assessed by the reliable and valid PROMIS Self-Efficacy for Managing Chronic Conditions Short-Form 4-item subscales (Cella et al., 2010; Lee et al., 2020).
Timepoint [1] 402654 0
3 months post baseline
Secondary outcome [2] 402657 0
User acceptability (e.g., messages easy to understand) is assessed via a self-report online survey using Likert-type questions (i.e., along a scale from Not at all to Very Much so). These questions are derived from questions used in prior research by this team:
Sherman KA, Shaw LK, Jørgensen L, Harcourt D, Cameron L, Boyages J, Elder E, Kirk J, Tucker K. Qualitatively understanding patients' and health professionals' experiences of the BRECONDA breast reconstruction decision aid. Psychooncology. 2017 Oct;26(10):1618-1624. doi: 10.1002/pon.4346. Epub 2017 Jan 30. PMID: 27957772.
and
Singleton, A., Partridge, S., Raeside, R., Regimbal, M., Hyun,
K., Chow, C., Sherman, K., Elder, E., Redfern, J. (2019). A text
message intervention to support women's physical and mental
health after breast cancer treatments (EMPOWER-SMS): a
randomised controlled trial protocol. BMC Cancer, 19(1), 1-8.
doi ="http://dx.doi.org/10.1186/s12885-019-5886-8"
Timepoint [2] 402657 0
3 months post baseline

Eligibility
Key inclusion criteria
Participants are eligible to participate if they are: over 18 years of age; clinically diagnosed with endometriosis; proficient in English; have access to the internet and a mobile phone; resident in Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-

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 intervention will be administered entirely online, along with randomisation. Concealment will be by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to conditions using a random generator following completion of the online baseline survey.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical and thematic analysis will be conducted using SPSS and nVIVO, respectively. With the aim of pilot studies to provide indicative data of an intervention’s potential benefit (Lee et al., 2014), this trial aimed to gain user acceptability and feasibility data to inform a future definitive trial. We will provide confidence interval estimates (95% through 75%) of the range of possible intervention effects for the outcomes of interest. Difference scores (3-month – baseline) are analysed using independent sample t-tests (or Mann-Whitney U-tests for small samples) based on a Minimal Clinically Important Difference (MCID) score for each outcome. Sub-sample analyses are undertaken for: 1) Indigenous only; 2) Taking hormone medication only; 3) Rural/regional located participants only; and 4) Participants indicating having medication taking difficulties. For participants assigned to the Intervention condition, descriptive data were reported regarding user acceptability, along with baseline characteristics of participants completing the study versus those who dropout, and SMS-system delivery data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2021
Actual
18/11/2021
Date of last participant enrolment
Anticipated
17/12/2021
Actual
8/12/2021
Date of last data collection
Anticipated
22/03/2022
Actual
30/03/2022
Sample size
Target
120
Accrual to date
Final
279
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310081 0
Charities/Societies/Foundations
Name [1] 310081 0
Endometriosis Australia
Country [1] 310081 0
Australia
Primary sponsor type
Individual
Name
Macquarie University
Address
School of Psychological Sciences, Balaclava Rd, Macquarie University, North Ryde, NSW, 2109
Country
Australia
Secondary sponsor category [1] 311141 0
None
Name [1] 311141 0
Address [1] 311141 0
Country [1] 311141 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309771 0
Macquarie University HREC (Medical Sciences)
Ethics committee address [1] 309771 0
Ethics committee country [1] 309771 0
Australia
Date submitted for ethics approval [1] 309771 0
15/02/2021
Approval date [1] 309771 0
13/05/2021
Ethics approval number [1] 309771 0
52021963527729

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

Contacts
Principal investigator
Name 115334 0
Prof Kerry Sherman
Address 115334 0
School of Psychological Sciences, Balaclava Rd, Nth Ryde, Macquarie University NSW 2109
Country 115334 0
Australia
Phone 115334 0
+61 298506874
Fax 115334 0
Email 115334 0
[email protected]
Contact person for public queries
Name 115335 0
Kerry Sherman
Address 115335 0
Centre for Emotional Health, School of Psychological Sciences, Balaclava Rd, Nth Ryde, Macquarie University NSW 2109
Country 115335 0
Australia
Phone 115335 0
+61 298506874
Fax 115335 0
Email 115335 0
[email protected]
Contact person for scientific queries
Name 115336 0
Kerry Sherman
Address 115336 0
School of Psychological Sciences, Balaclava Rd, Nth Ryde, Macquarie University NSW 2109
Country 115336 0
Australia
Phone 115336 0
+61 298506874
Fax 115336 0
Email 115336 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
We have not sought ethics approval for any individual data, only group data to be made publicly available. Rather, only deidentified group/combined data will be available at any stage


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13953Informed consent form    383069-(Uploaded-03-11-2021-16-43-18)-Study-related document.pdf
13954Study protocol    383069-(Uploaded-03-11-2021-16-43-39)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA supportive text message intervention for individuals living with endometriosis (EndoSMS): Randomized controlled pilot and feasibility trial.2023https://dx.doi.org/10.1016/j.conctc.2023.101093
N.B. These documents automatically identified may not have been verified by the study sponsor.