Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000410459p
Ethics application status
Submitted, not yet approved
Date submitted
31/03/2025
Date registered
6/05/2025
Date last updated
6/05/2025
Date data sharing statement initially provided
6/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Does adding therapist guidance to Finding My Way-Advanced improve engagement and outcomes in women with metastatic breast cancer? A feasibility pilot.
Scientific title
Does adding therapist guidance to Finding My Way-Advanced improve engagement and outcomes in women with metastatic breast cancer? A feasibility pilot.
Secondary ID [1] 313988 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
FMW-A+
Linked study record
ACTRN12618001492246- feasibility/pilot trial FMW-A.
ACTRN12621001482853p- study protocol for FMW-A RCT multisite evaluation.

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer 336712 0
Reduced mental quality of life 336713 0
Distress 336714 0
Condition category
Condition code
Cancer 333214 333214 0 0
Breast
Mental Health 333215 333215 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of the addition of guidance/human support to the Finding My Way - Advanced (FMW-A) web-based psychological intervention.

FMW-A is a 6-week, 6-module psychosocial program that addresses commonly experienced concerns raised by women with metastatic breast cancer (MBC). 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. A booster module is provided 10-weeks after enrolment, providing psychoeducation regarding maintaining wellbeing, a summary/review of the program, and links back to key resources. Module content is provided in a multimedia format, with video and written personal accounts from women living with MBC, educational videos from health care professionals, self-management activities, audio relaxation-mindfulness downloadable files, print psychoeducation with audio-conversion options, and illustrations/imagery throughout. Two key strategies facilitate usage. First, personalisation and free choice access: Based on pilot feedback and the adult learning literature, after viewing an introductory video and ‘how to use’ tutorial, all modules will be immediately accessible. Second, engagement/interactivity through provision of (i) worksheets, activities, and quizzes with immediate feedback; (ii) a ‘favourites’ and ‘notes feature’ to encourage participants to highlight and reflect on relevant content, a ‘where you left off’ feature to enable participants to immediately return to their last accessed page, and (iii) automated weekly email/text message reminders.

All participants will receive access to the FMW-A online program as described above. The three condition arms will be email, phone-call and video-call guidance. In the event of technological difficulties, video-call participants will be provided telephone calls for guidance. Intervention participants will receive guidance related to the program. The following dosage (i.e. how often/frequency) of human support is outlined; 1x Introduction Session simultaneously with Module 1 access, 1 x Check-In Session at 3-weeks, and an Optional Check-In Session between week 4-6 or following Module 6 completion. The total time of the guidance sessions will be recorded (estimated range: 20 - 60 minutes).

All human support will be focused on increasing engagement, and not on the provision of additional therapeutic support or content. The human support will be patient driven and will include, but is not limited to, answering questions related to the program content, module recommendations based on collaboratively developed goals and self-identified needs, encouraging the use of tools/strategies within the program, positive feedback/motivation, consolidation of module content, addressing barriers to engagement, and assistance with worksheets/activities within the program.

Risk mitigation/screening and managing distress, in addition to referral to additional supports or prompts to speak to current supports/the person's treatment team, will be done on an as needed basis determined through clinical judgement. Technological support will be provided as needed. The person providing the guidance, The provisional psychologists will take clinical notes during the sessions regarding the support required.

Engagement of participants in the FMW-A program will be evaluated through website recorded indicators; the number of modules accessed, number of pages accessed, number of logins, time spent, and number of worksheets completed. engagement of participants in the human support element of intervention conditions will be evaluated through objective indicators, such as session duration, number of sessions completed, and Session Rating Scale scores, as well as subjective indicators, such as qualitative feedback (e.g. asking participants how engaged they felt during the session).

Participants will be contacted by telephone following the release of the booster module (10-weeks post-baseline), to schedule an interview for the purposes of obtaining qualitative feedback on user satisfaction with the guidance (intervention) conditions. Participants who are willing to participate in this interview will then be sent a topic guide (via email) at least 1 week prior to their scheduled interview and will be contacted again at the agreed time for the interview to occur. Interviews will occur over the phone, via videoconferencing (Microsoft Teams), or in-person. Interviews will be audio recorded, and participants will be asked at the conclusion of the interview whether they would like to review their contribution prior to analysis. Those who would like to review their contribution will be sent a password protected word document containing their interview transcript via email and asked to review this within one week of receiving it. Participants may be asked to participate in subsequent interviews until consensus (agreement) has been reached.
Intervention code [1] 330573 0
Treatment: Other
Comparator / control treatment
A historical control condition will be utilised; the self-guided intervention arm that enrolled in the past 12 months of the nearly-completed FMW-A RCT (Trial ID ACTRN12621001482853p. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382714&isReview=true).
Control group
Historical

Outcomes
Primary outcome [1] 340796 0
Fidelity of guidance
Timepoint [1] 340796 0
Baseline, 6-weeks post-baseline
Primary outcome [2] 341104 0
Recruitment; uptake rate
Timepoint [2] 341104 0
12 months after study commencement
Primary outcome [3] 341105 0
Retention: attrition
Timepoint [3] 341105 0
Attrition determined at baseline, 6-weeks post-baseline, 3-month follow-up. Qualitative interview occurs following the release of the booster module (10-weeks post-baseline).
Secondary outcome [1] 445057 0
Quality of life
Timepoint [1] 445057 0
Baseline, 6-weeks post-baseline, 3-month follow-up
Secondary outcome [2] 445058 0
Psychological distress
Timepoint [2] 445058 0
Baseline, 6-weeks post-baseline, 3-month follow-up.
Secondary outcome [3] 445059 0
Cancer specific distress
Timepoint [3] 445059 0
Baseline, 6-weeks post-baseline, 3-month follow-up
Secondary outcome [4] 445060 0
Fear of progression
Timepoint [4] 445060 0
Baseline, 6-weeks post-baseline, 3-month follow-up
Secondary outcome [5] 445061 0
Self efficacy
Timepoint [5] 445061 0
Baseline, 6-weeks post baseline, 3-month follow-up
Secondary outcome [6] 446645 0
Adherence (Primary Outcome)
Timepoint [6] 446645 0
Baseline, 6-weeks post baseline
Secondary outcome [7] 446646 0
Engagement (Primary Outcome)
Timepoint [7] 446646 0
6-weeks post baseline
Secondary outcome [8] 446647 0
Acceptability
Timepoint [8] 446647 0
TFA 6-weeks post baseline, qualitative interview 10-weeks post-baseline

Eligibility
Key inclusion criteria
Women (1) 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 will be eligible. 
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No internet access / active email address, non-English speakers (note: those with English as a second language who have sufficient English-fluency for informed consent and program comprehension are eligible), or previous medical history of dementia.

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)
An online automated computer-program (RedCap) will randomly assign participants (1:1:1 ratio).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
An online automated computer-program (RedCap) will randomly assign participants (1:1:1 ratio) to one of three condition arms (email, phone-call or video-call guidance). All intervention conditions will then be compared to results of self-guided intervention participants in the FMW-A RCT (https://link.springer.com/article/10.1007/s11764-021-01019-5) who will act as a historical control condition.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Feasibility;
Descriptive statistics will be performed to summarise recruitment and retention indices, as well as objective indicators of engagement with the human support (e.g. session duration, number of sessions completed). Between-group t-tests will be conducted to evaluate differences between groups on SRS and TFA scores.

Efficacy;
Analysis will be by intention to treat. Linear Mixed Models (LMM) will be employed to examine the efficacy of the intervention, in line with the statistical methodology utilised in previous trials our group have published. Linear mixed models will be used to model all continuous outcomes while accounting for covariance between repeated measures on patients and adjusting for baseline measures, which improves precision of estimation of effects. These models will allow for: 1) comparing patterns of change over time by testing group by time interaction and 2) estimating and testing differences between groups at time points of interest via linear contrasts. Mixed models are valid for data that are missing completely at random and missing at random; patterns of missing data will be considered to assess potential missing data mechanisms. In the present study, the fixed main effects will be treatment condition (4; email, phone, video & control), and time (3: baseline, 6-weeks post baseline, and 3-month). If required (ie., for variables where there are large differences between group at baseline), the baseline measure of the outcome will be entered as a covariate. A random subject effect will be entered into the model to allow the trajectory for each individual to differ by a constant elevation from the group trajectory. Between-group ES and reliable change indices will be calculated to provide a measure of the magnitude and clinical significance of changes respectively.

Qualitative interview data
Qualitative interview data will be analysed using thematic analysis, to identify salient themes in participants experience of the human support.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
2/06/2026
Actual
Date of last data collection
Anticipated
2/10/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318490 0
University
Name [1] 318490 0
The Flinders University College of Education, Psychology and Social Work Higher Degree Research Scheme
Country [1] 318490 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 320884 0
None
Name [1] 320884 0
Address [1] 320884 0
Country [1] 320884 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317100 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 317100 0
Ethics committee country [1] 317100 0
Australia
Date submitted for ethics approval [1] 317100 0
20/03/2025
Approval date [1] 317100 0
Ethics approval number [1] 317100 0

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

Contacts
Principal investigator
Name 139994 0
Ms Amy Rigg
Address 139994 0
Flinders University College of Education, Psychology & Social Work GPO Box 2100 Adelaide SA 5001
Country 139994 0
Australia
Phone 139994 0
+61 08 8291 4964
Fax 139994 0
Email 139994 0
[email protected]
Contact person for public queries
Name 139995 0
Amy Rigg
Address 139995 0
Flinders University College of Education, Psychology & Social Work GPO Box 2100 Adelaide SA 5001
Country 139995 0
Australia
Phone 139995 0
+61 08 8291 4964
Fax 139995 0
Email 139995 0
[email protected]
Contact person for scientific queries
Name 139996 0
Amy Rigg
Address 139996 0
Flinders University College of Education, Psychology & Social Work GPO Box 2100 Adelaide SA 5001
Country 139996 0
Australia
Phone 139996 0
+61 08 8291 4964
Fax 139996 0
Email 139996 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No 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?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24627Study protocol    2024_HRE - Protocol_Finding My Way - Advanced+ RCT Version 3 CLEAN.docx
24628Informed consent form    PICF FMW-A+ RCT 20250121 Version 2 CLEAN.docx


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24627Study protocol    2024_HRE00040 - Protocol_Finding My Way - Advanced+ RCT Version 4 CLEAN 20250429.docx
24628Informed consent form    PICF FMW-A+ RCT 20250121 Version 2 CLEAN copy.docx
24791Ethical approval    Ethics Approval Email Final.pdf

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.