Finding My Way – Advanced: Developing and user testing an online coping program for women with advanced breast cancer

INTERVENTION: The intervention consists of the Finding My Way ‐ Advanced web‐based psychological intervention. This consists of six modules, released to participants at a rate of one module per week, 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) Diagnosis and working with my medical team; (2) Managing physical symptoms (particularly focusing on fatigue and pain); (3) Managing emotional distress; (4) Managing identity and role changes; (5) Social support: receiving support and supporting family; and (6) Living well with a progressing illness: managing fear of progression and coping with uncertainty. While the intervention is designed by health professionals and registration is facilitated by the project coordinator as needed, the intervention is self‐guided, with regular reminder emails released to participants each time a new module becomes available. The intervention is delivered individually and entirely online, with one module released each week for a total duration of six weeks. 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, with built in suggested breaks included in each module to allow women with lower physical capacity to tailor their participation. 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 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 l0ogged 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. CONDITION: Advanced breast cancer PRIMARY OUTCOME: Adherence rates will be assessed through usage indices; the Finding My Way ‐ Advanced website automatically records number of visits (logins), days logged in, session duration (time logged in), number of modules completed, number of pages viewed, and number of worksheets completed. Adherence data will therefore be collected from the web program. ; INCLUSION CRITERIA: ‐ Women recently diagnosed with advanced breast cancer (recent diagnosed defined as within the 12 months prior to approach by research team) ‐ Aged over 18 years ‐ Internet access and an active email address ‐ Sufficient English language skills for informed consent and program comprehension ‐ Life expectancy of at least 6 months ; Adherence for the purposes of this trial is defined as the amount of the intervention an individual engages with or completes. The primary measure of adherence is the number of modules engaged with (out of a total of six modules), with secondary measures of adherence including number of days logged in to the intervention, number of logins to the intervention, number of pages viewed, and total time logged in to the intervention. ; Satisfaction ratings: participant satisfaction will be assessed using self‐report measures of satisfaction adapted from a previous trial of an online intervention (Beatty, L., Kemp, E., Wade, T., & Koczwara, B. (2015). Finding My Way: protocol of a randomised controlled trial evaluating an internet self‐help program for cancer‐related distress. BMC cancer, 15(1), 328). These measures include single‐item Likert‐type measures of how helpful participants found (a) information (b) worksheets (c) audio tracks, and (d) how confident they feel applying the program to their everyday life. Uptake rates, assessed as the percentage of approached, eligible women who participate, with data collected from recruitment records. SECONDARY OUTCOME: Post‐intervention survey attrition, defined as the proportion of participants who complete a post‐treatment survey battery of efficacy outcome measures proposed for further study. Survey attrition data will be assessed by accessing post‐treatment survey data collected via the web program in order to ascertain the proportion of participants who complete post‐treatment surveys. .