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Trial registered on ANZCTR


Registration number
ACTRN12618001492246
Ethics application status
Approved
Date submitted
28/08/2018
Date registered
5/09/2018
Date last updated
25/09/2019
Date data sharing statement initially provided
25/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Finding My Way – Advanced: Developing and user testing an online coping program for women with advanced breast cancer
Scientific title
Finding My Way – Advanced: Usability and feasibility testing of a web-based psychological intervention for women with advanced breast cancer
Secondary ID [1] 295658 0
Cancer Council SA Beat Cancer Project Grant APP1140482
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced breast cancer 309002 0
Condition category
Condition code
Cancer 307897 307897 0 0
Breast

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, 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.
Intervention code [1] 301977 0
Treatment: Other
Comparator / control treatment
Usual care including the provision of print-based 'Hope & Hurdles' kit, the key resource provided by Breast Cancer Network Australia to women diagnosed with metastatic breast cancer which is the current 'gold standard' of usual psychological care for women diagnsoed with advanced breast cancer, and a link to access Hope & Hurdles materials online.
Control group
Active

Outcomes
Primary outcome [1] 306870 0
Uptake rates, assessed as the percentage of approached, eligible women who participate, with data collected from recruitment records.
Timepoint [1] 306870 0
Uptake rates will be assessed at the end of the recruitment period (i.e. when the target number of participants for this study have been recruited to the trial).
Primary outcome [2] 306871 0
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.

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.
Timepoint [2] 306871 0
Adherence data will be collected by the website on an ongoing basis and data downloaded for analysis two weeks after completing the final intervention module (as some lag including logging in and out of modules is expected).
Primary outcome [3] 306872 0
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.
Timepoint [3] 306872 0
Participant satisfaction will be assessed using single items completed at the conclusion of each module, with mean ratings then calculated across all six modules at the time of data analysis.
Secondary outcome [1] 350163 0
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. .
Timepoint [1] 350163 0
As participants will receive reminder emails to complete the post-treatment survey over two weeks after completing the final module and will then be followed up by telephone with some time lapse allowed for survey completion, survey attrition will be assessed one month after final module completion.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- No internet access or 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)
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 analysing the results/data
Intervention assignment
Parallel
Other design features
This study is planned as a single-site pre-post pilot RCT, to provide feasibility (uptake, adherence, survey adherence, satisfaction) data.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Descriptive statistical analysis of uptake, treatment adherence, survey adherence, satisfaction ratings.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11550 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 23578 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 300237 0
Charities/Societies/Foundations
Name [1] 300237 0
Cancer Council SA
Address [1] 300237 0
202 Greenhill Rd
Eastwood
SA 5063
Country [1] 300237 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Cancer Council SA
Address
202 Greenhill Rd
Eastwood
SA 5063
Country
Australia
Secondary sponsor category [1] 299717 0
None
Name [1] 299717 0
Address [1] 299717 0
Country [1] 299717 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301060 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 301060 0
Southern Adelaide Local Health Network Office for Research
Ward 6C, Room 6A219
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 301060 0
Australia
Date submitted for ethics approval [1] 301060 0
03/09/2018
Approval date [1] 301060 0
08/07/2019
Ethics approval number [1] 301060 0
HREC18SAC305

Summary
Brief summary
The purpose of this study is to determine whether an online psychological intervention is feasible for women with advanced breast cancer.

Who is it for?

You may be eligible for this study if you are a female adult who has recently been diagnosed with advanced breast cancer.

Study details

Participants in this study will be randomly allocated 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 advanced breast cancer. Topics addressed by the modules include (1) Diagnosis and working with my medical team; (2) Managing physical symptoms (particularly 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. Modules are released at a rate of one per week for six weeks, and participants will be able to access modules as much as needed during the intervention.

Group 2: Participants in this group will receive a print-based resource provided by the Breast Cancer Network Australia.

Participants in both groups will be followed up by researchers after completing the six week program, and asked to complete an online questionnaire assessing psychological well-being and quality of life.

It is hoped that this research will help inform future, larger scale studies on the feasibility of an online intervention for women with advanced breast cancer.
Trial website
https://www.findingmywayadvanced.org.au
Trial related presentations / publications
Beatty L, Kemp E, Butow P, Girgis A, Turner J, Schofield P, Hulbert-Williams N, Kaambwa B, Koczwara B. (2018). Finding My Way-Advanced: Development and usability testing of a web-based self-directed psychosocial intervention for women with metastatic breast cancer. Psycho-Oncology, 27: 89. International Psycho-Oncology Society (IPOS) 2018 World Congress of Psycho-Oncology. October 29-November 2 2018. Hong Kong.
Public notes

Contacts
Principal investigator
Name 85746 0
Dr Lisa Beatty
Address 85746 0
Flinders Cancer Research
College of Medicine and Public Health
Flinders University
GPO Box 2100 Adelaide South Australia, 5001
Country 85746 0
Australia
Phone 85746 0
+ 61 8 8201 2506
Fax 85746 0
Email 85746 0
lisa.beatty@flinders.edu.au
Contact person for public queries
Name 85747 0
Dr Lisa Beatty
Address 85747 0
Flinders Cancer Research
College of Medicine and Public Health
Flinders University
GPO Box 2100 Adelaide South Australia, 5001
Country 85747 0
Australia
Phone 85747 0
+ 61 8 8201 2506
Fax 85747 0
Email 85747 0
lisa.beatty@flinders.edu.au
Contact person for scientific queries
Name 85748 0
Dr Lisa Beatty
Address 85748 0
Flinders Cancer Research
College of Medicine and Public Health
Flinders University
GPO Box 2100 Adelaide South Australia, 5001
Country 85748 0
Australia
Phone 85748 0
+ 61 8 8201 2506
Fax 85748 0
Email 85748 0
lisa.beatty@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 5056 0
Study protocol
Citation [1] 5056 0
Link [1] 5056 0
Email [1] 5056 0
lisa.beatty@flinders.edu.au
Other [1] 5056 0
Attachment [1] 5056 0
Summary results
No Results