None listed
Conditions
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.
Interventions
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 re
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.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed