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Finding My Way-Advanced: Can a web-based psychosocial intervention improve mental quality of life for women with metastatic breast cancer?

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001482853
Acronym
FMW-A
Enrollment
280
Registered
2021-10-29
Start date
2022-08-10
Completion date
2025-01-21
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Metastatic breast cancer impairs quality of life (QOL), causes distress, and has a high health-system burden, yet few studies have examined interventions to address this. Our research group recently developed an online psychosocial program for women with metastatic breast cancer “Finding My Way-Advanced”. The purpose of this study is to test whether, compared to a control group, Finding My Way-Advanced leads to improved QOL, distress and health care use for women with metastatic breast cancer. Who is it for? You may be eligible for this study if you are a woman aged 18 years or older who has recently been diagnosed with metastatic breast cancer (MBC). Study details Participants in this study will be randomly allocated (i.e. allocated by chance) to one of two groups: Group 1: Participants in this group will be provided with an online intervention consisting of 6 modules which focus on improving the psychological well-being and quality of life of women diagnosed with metastatic breast cancer. Topics addressed by the modules include (1) Navigating healthcare (making decisions and communicating with my health care team), (2) Living well with a progressing illness: Managing fear of progression and coping with uncertainty; (3) Managing physical symptoms (particularly fatigue and pain); (4) Managing emotional distress; (5) Managing identity and role-changes; and (6) Social support: receiving support and supporting family. Participants will be able to access all modules immediately, and use them as much as needed during the intervention. They will receive weekly reminders to log in and use the program, over the 6 week study period. Group 2: Participants in this group will receive links to Breast Cancer Network Australia's 'gold standard' resource for women with metastatic breast cancer: “My Journey Online Tool”. This key resource will be supplemented with the static digital downloadable “Hope & Hurdles” kit specific to 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. Participants in both groups will complete self-report measures of quality of life, distress, unmet needs and health service use, before they receive access to their program. They will then be followed up by researchers 6-weeks after receiving access to their program, and asked to complete the same online questionnaire assessing quality of life, distress, and health service use. Participants will be asked to complete these same research surveys 3 and 6 months later. It is hoped that this research will demonstrate that the Finding My Way-Advanced program improves quality of life, distress and health service use in women with MBC.

Interventions

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 ad

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.

Sponsors

Lisa Beatty
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

- No internet access, no active email address - previous medical history of dementia or cognitive impairment

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 10, 2026