Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001482853
Ethics application status
Approved
Date submitted
15/09/2021
Date registered
29/10/2021
Date last updated
21/01/2024
Date data sharing statement initially provided
29/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Finding My Way-Advanced: Can a web-based psychosocial intervention improve mental quality of life for women with metastatic breast cancer?
Scientific title
Finding My Way-Advanced: Can a web-based psychosocial intervention improve mental quality of life for women with metastatic breast cancer? A multi-site randomised controlled trial.
Secondary ID [1] 305214 0
None
Universal Trial Number (UTN)
Trial acronym
FMW-A
Linked study record
ACTRN12618001492246 - this was the usability/feasibility pilot trial; (whereas the current record is for the multisite evaluation).

Health condition
Health condition(s) or problem(s) studied:
metastatic breast cancer 323641 0
Reduced mental quality of life 323936 0
Condition category
Condition code
Cancer 321178 321178 0 0
Breast
Mental Health 321179 321179 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of the Finding My Way - Advanced web-based psychological intervention.

This consists of six modules, each consisting of three main components: (1) psychoeducation/information, (2) interactive empirically-supported cognitive-behavioural and mindfulness-based worksheets/strategies, including: worksheets, quizzes, detached mindfulness, relaxation, acceptance of emotions, assertive communication, values clarification, and goal setting; and (3) testimonials of women with advanced breast cancer (ABC). Content is provided in a multimedia format, including text, graphics, audio-clips (mindfulness and relaxation), and video (testimonials; psychoeducation/information clips from health professionals). Each of the six modules focuses on a different topic, namely (1) Navigating healthcare and making decisions; (2) Living well with a progressing illness (managing fear of progression and coping with uncertainty); (3) Managing physical symptoms (particularly focusing on fatigue and pain); (4) Managing emotional distress; (5) Managing identity and role changes; and (6) Social support: receiving support and supporting family.

The intervention is delivered individually and entirely online. While the intervention is co-designed by cancer consumers, advocates, and health professionals, and registration is facilitated by the project coordinator as needed, the intervention is self-guided. Based on pilot feedback and the adult learning literature, after viewing an introductory video and 'how to use' tutorial, all six modules will be immediately accessible; with weekly reminder emails/text messages released to participants to encourage engagement. Each module is anticipated to take approximately one hour in total to complete; however participants may log in and out of each module as many times as they like. Participants will be informed that the total duration of the intervention is 6-weeks (based on an average of accessing one module per week), however they are welcome to access to modules at a pace that suits them, which may be more or less frequent than once-weekly.

The setting for intervention delivery is online, with the intervention accessed from the participant's location of choice (e.g. home, work).

Some self-tailoring is built into the program, with participants able to access the modules in the order of their preference so as to tailor for their interests and concerns, as well as log in and out of the program as needed so as to allow for varying availability and capability. However the program content provided to each intervention participant is the same.

Adherence to the intervention is encouraged using weekly emails/text messages reminding participants of each module release as described above. Adherence is assessed via the web program using indices of program usage, including number of modules accessed, number of logins, number of days logged in, number of pages viewed, and total time logged in.

In the intervention condition, the Finding My Way - Advanced intervention is received in addition to usual care materials described below.
Intervention code [1] 321725 0
Treatment: Other
Comparator / control treatment
Minimal-intervention attention-control

The control arm will receive a minimal intervention attention-control, comprised of a homepage that contains links to Breast Cancer Network Australia’s metastatic breast cancer (MBC) resource: “My Journey Online Tool”. This key resource will be supplemented with the static digital downloadable “Hope & Hurdles” kit, the current 'gold standard' of usual psychological care for women with MBC, which includes (a) an introductory booklet about MBC; (b) an information guide (which provides detailed information about diagnosis, treatments, support options, practical issues, and further contacts and resources), and (c) videos from a woman living with MBC and a health care provider. Links to optional online resources will also be provided.
Control group
Active

Outcomes
Primary outcome [1] 328967 0
mean Mental Quality of Life (QoL), assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) emotional functioning subscale.
Timepoint [1] 328967 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Primary timepoint: 6 weeks after intervention commencement ('post-intervention')
Secondary outcome [1] 400988 0
mean global QOL, assessed by the EORTC QLQ-C30 global QOL subscale.
Timepoint [1] 400988 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Secondary outcome [2] 400989 0
mean Psychological distress, measured by the 21-item Depression Anxiety Stress Scale (DASS). Assesses anxiety, depression and stress over the previous week; total distress score will be used.
Timepoint [2] 400989 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Secondary outcome [3] 400990 0
mean Fear of Progression, measured by the English-version of the 12-item Fear of Progression Questionnaire short form (FoP-Q-SF).
Timepoint [3] 400990 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Secondary outcome [4] 400991 0
mean Unmet Needs, measured with the 34-item Supportive Care Needs Survey–Short Form (SCNS-SF). Measures perceived psychosocial, information, physical/activity of daily living, patient care and sexuality needs. Total scale score will be utilised.
Timepoint [4] 400991 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Secondary outcome [5] 400992 0
Quality of life assessed using the EuroQol 5 dimensions 5 level (EQ-5D-5L).
Timepoint [5] 400992 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Secondary outcome [6] 400993 0
Health Service Utilisation: Medicare Benefits Schedule (MBS) data will be accessed to determine the number and costs of primary care visits.
Timepoint [6] 400993 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Secondary outcome [7] 401842 0
Health Service Utilisation: Medicare Benefits Schedule (MBS) data will be accessed to determine the number and costs of medical consultations.
Timepoint [7] 401842 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Secondary outcome [8] 401843 0
Health Service Utilisation: MBS data will be accessed to determine the number and costs of medical treatments.
Timepoint [8] 401843 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Secondary outcome [9] 401844 0
Health Service Utilisation: MBS data will be accessed to determine the number and costs of investigations,
Timepoint [9] 401844 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Secondary outcome [10] 401845 0
Health Service Utilisation: MBS data will be accessed to determine the number and costs of out-of-hospital visits.
Timepoint [10] 401845 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Secondary outcome [11] 401846 0
Health Service Utilisation: Pharmaceutical Benefits Scheme (PBS) data will be used to estimate quantity and costs of pharmaceuticals.
Timepoint [11] 401846 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Secondary outcome [12] 401847 0
Health Service Utilisation: centralised costing data from public hospitals (Australian Refined Diagnosis Related Groups (AR-DRGs) will be accessed to determine the number and costs of public hospital inpatient episodes (which includes emergency department visits).
Timepoint [12] 401847 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Secondary outcome [13] 401848 0
mean Physical QOL, measured by the EORTC QLQ-C30 physical functioning subscale.
Timepoint [13] 401848 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Secondary outcome [14] 401849 0
mean Social QOL, measured by the EORTC QLQ-C30 social functioning subscale.
Timepoint [14] 401849 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Secondary outcome [15] 401850 0
mean Role functioning QOL, measured by the EORTC QLQ-C30 role functioning subscale.
Timepoint [15] 401850 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.
Secondary outcome [16] 401851 0
mean Cognitive QOL, measured by the EORTC QLQ-C30 cognitive functioning subscale.
Timepoint [16] 401851 0
Timepoints: baseline (pre-intervention); 6 weeks post-intervention commencement; 3-months post-intervention completion; 6 months post-intervention completion.

Eligibility
Key inclusion criteria
(1) Women with a diagnosis of MBC;
(2) aged 18 years or older,
(3) life expectancy of over 6 months (clinician’s judgement), and
(4) sufficient English-fluency for informed consent and program comprehension
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- No internet access, no active email address
- previous medical history of dementia or cognitive impairment

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation - An online computer algorithm within the web-platform will randomly assign participants in blocks of four to intervention or control, with stratification by recruitment site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features


Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis will be by intention to treat (ITT). Linear Mixed Models (LMM) will be employed to examine the efficacy of the intervention for the primary and secondary continuous outcomes. The LMM approach accounts for the repeated measures on patients, allows adjustment for baseline values, and improves the precision of estimated effects in the presence of missing data. These models will allow us to compare the overall pattern of change over time between the 2 groups using a treatmentXtime interaction effect and estimating and testing differences between groups at each time point of interest via linear contrasts. Mixed models are valid for data that are missing completely at random (MCAR) or missing at random (MAR); the mechanisms of missing data will be considered to ensure these assumptions are met. If the data is MCAR or MAR and more than 10% of data is missing, we will also employ multiple imputation in order to adhere to the ITT principle. In the present study, the fixed main effects will be treatment condition (intervention, control), time (post-treatment, 3-month, 6-month), treatmentXtime, and baseline values of the outcome in order to enhance precision. A random intercept for the subject will be included and we will also employ random slopes for subjects if it improves model fit. Between-group effect sizes with 95% confidence intervals will be calculated and a 2-sided Type 1 error rate of alpha=0.05 will be employed for each of the primary and secondary outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
10/08/2022
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
370
Accrual to date
176
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 309594 0
Government body
Name [1] 309594 0
Cancer Australia
Country [1] 309594 0
Australia
Primary sponsor type
Individual
Name
Lisa Beatty
Address
Flinders University
College of Education, Psychology & Social Work
GPO Box 2100
Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 310604 0
None
Name [1] 310604 0
Address [1] 310604 0
Country [1] 310604 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309370 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 309370 0
Ethics committee country [1] 309370 0
Australia
Date submitted for ethics approval [1] 309370 0
29/11/2021
Approval date [1] 309370 0
18/02/2022
Ethics approval number [1] 309370 0
2021/HRE00407

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

Contacts
Principal investigator
Name 113914 0
A/Prof Lisa Beatty
Address 113914 0
Flinders University
College of Education, Psychology & Social Work
GPO Box 2100
Adelaide SA 5001
Country 113914 0
Australia
Phone 113914 0
+61 08 82012506
Fax 113914 0
Email 113914 0
[email protected]
Contact person for public queries
Name 113915 0
Lisa Beatty
Address 113915 0
Flinders University
College of Education, Psychology & Social Work
GPO Box 2100
Adelaide SA 5001
Country 113915 0
Australia
Phone 113915 0
+61 08 82012506
Fax 113915 0
Email 113915 0
[email protected]
Contact person for scientific queries
Name 113916 0
Lisa Beatty
Address 113916 0
Flinders University
College of Education, Psychology & Social Work
GPO Box 2100
Adelaide SA 5001
Country 113916 0
Australia
Phone 113916 0
+61 08 82012506
Fax 113916 0
Email 113916 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
At this stage IPD will not be available to protect participant confidentiality and anonymity (given the specific population).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13213Study protocolBeatty, L., Kemp, E., Butow, P. et al. Finding My Way-Advanced: can a web-based psychosocial intervention improve the mental quality of life for women with metastatic breast cancer vs attention-control? Study protocol of a randomised controlled trial. BMC Cancer 22, 1353 (2022). https://doi.org/10.1186/s12885-022-10410-zhttps://bmccancer.biomedcentral.com/articles/10.1186/s12885-022-10410-z 



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFinding My Way-Advanced: can a web-based psychosocial intervention improve the mental quality of life for women with metastatic breast cancer vs attention-control? Study protocol of a randomised controlled trial.2022https://dx.doi.org/10.1186/s12885-022-10410-z
N.B. These documents automatically identified may not have been verified by the study sponsor.