Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000592741p
Ethics application status
Submitted, not yet approved
Date submitted
23/03/2022
Date registered
21/04/2022
Date last updated
21/04/2022
Date data sharing statement initially provided
21/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the impact of a self-guided digital intervention for fear of cancer recurrence (iConquerFear) in ovarian cancer survivors
Scientific title
Assessing the impact of a self-guided digital intervention for fear of cancer recurrence (iConquerFear) in ovarian cancer survivors: a pilot randomised waitlist-controlled trial
Secondary ID [1] 306459 0
None
Universal Trial Number (UTN)
U1111-1274-4125
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fear of cancer recurrence 325304 0
Fear of progression 325305 0
Depression 325307 0
Ovarian cancer 325876 0
Condition category
Condition code
Cancer 322702 322702 0 0
Ovarian and primary peritoneal
Mental Health 323188 323188 0 0
Depression
Mental Health 323189 323189 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
iConquerFear is a 5-module web-based programme that gives information and guides people to develop skills to cope with fear of cancer recurrence (FCR). The intervention focuses on meaningful life goals/actions based on core personal values rather than worries about recurrence. iConquerFear uses interactive activities (e.g. attention training and mindfulness) to help survivors direct less attention towards and engage less with worries about recurrence, and follow self-examination and follow-up recommendations. A diverse range of formats is used during the intervention, including written information, interaction and audio-visual aids, and videos of ovarian cancer survivors reflecting on their experience of FCR. Modules were designed for sequential completion (every single module might take approximately 1-2 hours) over a week and a half approximately (estimating that the 5 modules can be completed in 8 weeks total). Modules can be completed in a self-paced manner. Some participants might take 8 weeks to complete the 5 modules while others might complete them in 1 week. Modules are designed to encourage participants to practice the skills learned between modules (facilitated by reminders). The informational materials provided in each module were designed specifically for iConquerFear and they are based on current scientific evidence and cancer management guidelines. iConquerFear content is understandable by 91% of the Australian population (Grade 9/10 educated people, Flesch-Kincaid Readability Score 9.4). The five modules include:

-Welcome Module: this is a brief module explaining what is iConquerFear and how it works. It also helps the participant to better understand the concept of FCR. The module should take approximately 20 minutes to complete.
-Module 1 - A new way to manage fear of cancer recurrence: this module helps participants to understand why it is easy to get stuck in a cycle of worry about cancer returning and how to act in line with participants’ values.
-Module 2 - Attention training: this module helps participants to reduce their attention on worry. It provides a series of strategies to reduce worries.
-Module 3 - Detached mindfulness: this module teaches participants to get less caught up in worries about cancer recurrence.
-Module 4 - Living well and managing worry: this module helps participants to learn about how to live and manage worry on an ongoing basis.
-Module 5 - Maintaining changes: this module facilitates the prevention of concerns of fear coming back after the program is completed.

The adherence to the intervention will be monitored by the website which will track the overall completion progress, module completion, as well as the number of logins and time spent using the website.
Intervention code [1] 322891 0
Behaviour
Comparator / control treatment
Participants in the waitlist control group will receive the Ovarian Cancer Australia fact-sheet on fear of cancer recurrence for ovarian cancer patients (https://www.ovariancancer.net.au/page/230/fear-of-cancer-recurrence-factsheet). The fact-sheet will be delivered online. Full access to iConquerFear upon questionnaire completion after 8 weeks of enrolment will be given to the waitlist control group.
Control group
Active

Outcomes
Primary outcome [1] 330502 0
Feasibility. This will be assessed by a composite of:
- The proportion of referred ovarian cancer survivors who access iConquerFear (baseline) by using the participant tracking log and referral database from Ovarian Cancer Australia.
- The proportion of iConquerFear module completion (8 weeks post website access) by using website data.
- The average number of logins and the average duration of logins (8 weeks post website access) by using website data.
Timepoint [1] 330502 0
Baseline, and 8 weeks post website access (primary timepoint).
Primary outcome [2] 330503 0
Acceptability. This will be assessed by a composite of:
- The satisfaction and usefulness of iConquerFear as a whole (8 weeks post website access) by using study-specific questions and the The Internet Evaluation and Utility Questionnaire (IEUQ)
- The satisfaction with each iConquerFear module (after every module) by using a star rating satisfaction question
- The likelihood of recommending iConquerFear to other ovarian cancer survivors (8 weeks post website access) by using a study-specific question.
Timepoint [2] 330503 0
After every module has been completed, and 8 weeks post website access (primary timepoint)
Secondary outcome [1] 406459 0
Fear of Cancer Recurrence. This will be assessed by using the Fear of Cancer Recurrence Inventory - Short Form (FCRI-SF).
Timepoint [1] 406459 0
Baseline, 8 weeks post website access and 20 weeks post website access.
Secondary outcome [2] 406460 0
Fear of progression. This will be assessed by using the Fear of Progression Questionnaire – Short Form (FoP-Q-SF).
Timepoint [2] 406460 0
Baseline, 8 weeks post website access and 20 weeks post website access.
Secondary outcome [3] 406462 0
Depression. This will be assessed by using the Patient Health Questionnaire (PHQ-9).
Timepoint [3] 406462 0
Baseline, 8 weeks post website access and 20 weeks post website access.
Secondary outcome [4] 406464 0
Participants' experiences and views around the iConquerFear eHealth intervention will be assessed via semi-structured interviews conducted after having access to the website for at least 8 weeks.
Timepoint [4] 406464 0
8-weeks post website access
Secondary outcome [5] 407826 0
Safety. This will be assessed as a composite outcome by multiple means: a) Using the single-item fear of cancer recurrence assessment (FCR-1) and single-item Distress Thermometer (DT) administered after each module through the website, b) Comparing baseline and post-intervention scores of the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) administered through the website, and c) Monitoring the reasons for study withdrawal.
Timepoint [5] 407826 0
After every module has been completed and 8 weeks post website access.

Eligibility
Key inclusion criteria
The study will include those who:
a) Are 18 years of age or older,
b) were diagnosed with early (stages I-II) or locally-advanced ovarian cancer (stage III),
c) have completed hospital-based treatment (surgery, radiotherapy or chemotherapy),
d) are able to provide informed consent to participate in research,
e) are proficient in English (i.e. able to read, write and speak English),
f) have low to moderate levels of depression (PHQ-9 scores equal or more than 20) and no suicidal ideation (equal to 0 on the PHQ-9 item-9)
g) have an email address and regular access to the internet, and
h) have an electronic device such as a PC, laptop, tablet or smartphone.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The study will exclude those who:
a) Are 17 years or younger,
b) are not able to provide informed consent to participate in research,
c) are not English proficient (able to read, write and speak English),
d) have not had a diagnosis of ovarian cancer,
e) have been diagnosed with stage IV ovarian cancer,
f) have not completed initial treatment yet,
g) are diagnosed with an ovarian cancer recurrence during the study,
h) have severe levels of depression (PHQ-9 equal to or less than 19) or suicidal ideation (greater than or equal to 1 on PHQ-9 item-9)
i) do not have an email address and regular access to the internet, and
j) do not have an electronic device such as a PC, laptop, iPad or smartphone.

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 software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative analysis on feasibility, acceptability, safety, and preliminary efficacy of iConquerFear will be conducted via simple comparisons, including t-tests, Chi-square and Fishers’ exact test when appropriate. Linear mixed models will be used to analyse repeated measures data. Furthermore, qualitative analysis will be conducted to explore participants’ experiences, challenges and potential adverse effects using iConquerFear via questionnaire and interviews. This qualitative data will be analysed using thematic analysis as described by Braun and Clarke

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/04/2022
Actual
Date of last participant enrolment
Anticipated
23/12/2022
Actual
Date of last data collection
Anticipated
15/05/2023
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 310784 0
Charities/Societies/Foundations
Name [1] 310784 0
Ovarian Cancer Australia
Country [1] 310784 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney, Kensington, NSW, 2052
Country
Australia
Secondary sponsor category [1] 312056 0
None
Name [1] 312056 0
None
Address [1] 312056 0
None
Country [1] 312056 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310358 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 310358 0
UNSW Sydney, Kensington, NSW, 2052
Ethics committee country [1] 310358 0
Australia
Date submitted for ethics approval [1] 310358 0
07/04/2022
Approval date [1] 310358 0
Ethics approval number [1] 310358 0

Summary
Brief summary
The aim of this study is to investigate the feasibility, acceptability, safety, and preliminary efficacy of an online self-management program (iConquerFear) designed by our team to address fear of cancer recurrence (FCR) in individuals with ovarian cancer.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, have been diagnosed with early (stages I-II) or locally-advanced (stage III) ovarian cancer, and have completed hospital-based surgery, radiotherapy, or chemotherapy.

Study details
Participants will be randomised (i.e. allocated by chance) to receive the iConquerFear program or to a waitlist control group. iConquerFear is a 5-module web-based program that gives information and guides people to develop skills to cope with FCR. iConquerFear uses written information, interaction and audio-visual aides, including videos of cancer survivors reflecting on their experience of FCR and how iConquerFear has been a useful resource. Each module will take approximately 1-2 hours to complete, and can be completed at your own pace during the 8-week study period. Those allocated to the waitlist control group will instead receive the Ovarian Cancer Australia fact-sheet on FCR, and will receive full access to the iConquerFear program upon completion of the 8-week study questionnaire. All participants will be asked to complete a number of questionnaires before commencing the study, after each module, at 8 weeks post-commencement, and at 20 weeks post-commencement, to assess the feasibility, acceptability, safety, and efficacy of the program. Participants might also undergo an interview (optional) at the completion of the study to assess participants’ experiences and views around the iConquerFear eHealth intervention.

It is hoped that this study may demonstrate that the iConquerFear program is feasible, acceptable, safe, and efficacious for managing FCR in individuals with ovarian cancer. This may provide support for a larger randomised controlled trial to demonstrate the effectiveness and cost-effectiveness of the program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117370 0
Dr Allan 'Ben' Smith
Address 117370 0
1 Campbell st, Ingham Institute for Applied Medical Research, Liverpool, NSW, 2170
Country 117370 0
Australia
Phone 117370 0
+61438634964
Fax 117370 0
Email 117370 0
ben.smith@unsw.edu.au
Contact person for public queries
Name 117371 0
Dr Allan 'Ben' Smith
Address 117371 0
1 Campbell st, Ingham Institute for Applied Medical Research, Liverpool, NSW, 2170
Country 117371 0
Australia
Phone 117371 0
+61438634964
Fax 117371 0
Email 117371 0
ben.smith@unsw.edu.au
Contact person for scientific queries
Name 117372 0
Dr Allan 'Ben' Smith
Address 117372 0
1 Campbell st, Ingham Institute for Applied Medical Research, Liverpool, NSW, 2170
Country 117372 0
Australia
Phone 117372 0
+61438634964
Fax 117372 0
Email 117372 0
ben.smith@unsw.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
Participant data will not be available as per Ethics guidelines.


What supporting documents are/will be available?

No Supporting Document Provided



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.