None listed
Conditions
Brief summary
A substantial percentage of people with metastatic breast cancer (MBC) experience poor quality-of-life and elevated distress, yet few interventions address this. The few intervention studies that have been done have mainly focused on high intensity and high burden interventions, such as face-to-face therapies, without consideration of low intensity options, such as digital interventions. Beatty and colleagues were among the first to design an online self-directed intervention for people with MBC; Finding My Way-Advanced (FMW-A). However, the efficacy of low intensity digital interventions may be impacted by low engagement. The purpose of this study is to explore methods of increasing engagement in this population, with the addition of guidance appearing to be promising in digital mental health interventions. Who is it for? You may be eligible for this study if you are a woman aged 18+ who has been diagnosed with MBC. Study details Participants will be randomly allocated (i.e. allocated by chance) to one of three condition arms: email, phone-call and video-call guidance. Participants will receive a 6-module psychosocial program that addresses commonly experienced concerns raised by women with MBC. 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. Module content is provided in multimedia format, with video and written personal accounts from women living with MBC, educational videos from health care professionals, self-management activities, audio relaxation-mindfulness files, print psychoeducation with audio-conversion options, and illustrations/imagery throughout. Participants in all 3 conditions will be assessed for feasibility and complete self-report measures of quality-of-life, psychological distress, cancer specific distress, fear of progression, self-efficacy and positive psychology outcomes at the baseline. They will then be asked to complete the same online questionnaire assessing quality of life, distress, health service use and positive psychology outcomes at 6-weeks and 3 months later. Engagement will be evaluated through objective indicators (e.g. number of modules accessed, duration of human support), and subjective indicators (e.g. self-report/verbal feedback). Participants will also have the opportunity to complete a qualitative interview to provide feedback on their satisfaction with the human support. It is hoped that this research will provide participants with additional information and support to improve their quality of life and wellbeing, and to improve our understanding in the psycho-oncology field on how best to offer guidance in online programs.
Interventions
The intervention consists of the addition of guidance/human support to the Finding My Way - Advanced (FMW-A) web-based psychological intervention. FMW-A is a 6-week, 6-module psychosocial program that addresses commonly experienced concerns raised by women with metastatic breast cancer (MBC). 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. A booster module is provided 10-weeks after enrolment, providing psychoeducation regarding maintaining wellbeing, a summary/review of the program, and links back to key resources. Module content is provided in a multimedia format, with video and written personal accounts from women living with MBC, educational videos from health care professionals, self-management activities, audio relaxation-mindfulness downloadable files, print psychoeducation with audio-conversion options, and illustrations/imagery throughout. Two key strategies facilitate usage. First, personalisation and free choice access: Based on pilot feedback and the adult learning literature, after viewing an introductory video and ‘how to use’ tutorial, all modules will be immediately accessible. Second, engagement/interactivity through provision of (i) worksheets, activities, and quizzes with immediate feedback; (ii) a ‘favourites’ and ‘notes feature’ to encourage participants to highlight and reflect on relevant content, a ‘where you left off’ feature to enable participants to immediately return to their last accessed page, and (iii) automated weekly email/text message reminders. All participants will receive access to the FMW-A online program as described above. The three condition arms will be email, phone-call and video-call guidance. In the event of technological difficulties, video-call participants will be provided telephone calls for guidance. Intervention participants will receive guidance related to the program. The following dosage (i.e. how often/frequency) of human support is outlined; 1x Introduction Session simultaneously with Module 1 access, 1 x Check-In Session at 3-weeks, and an Optional Check-In Session between week 4-6 or following Module 6 completion. The total time of the guidance sessions will be recorded (estimated range: 20 - 60 minutes). All human support will be focused on increasing engagement, and not on the provision of additional therapeutic support or content. The human support will be patient driven and will include, but is not limited to, answering questions related to the program content, module recommendations based on collaboratively developed goals and self-identified needs, encouraging the use of tools/strategies within the program, positive feedback/motivation, consolidation of module content, addressing barriers to engagement, and assistance with worksheets/activities within the program. Risk mitigation/screening and managing distress, in addition to referral to additional supports or prompts to speak to current supports/the person's treatment team, will be done on an as needed basis determined through clinical judgement. Technological support will be provided as needed. The person providing the guidance, The provisional psychologists will take clinical notes during the sessions regarding the support required. Engagement of participants in the FMW-A program will be evaluated through website recorded indicators; the number of modules accessed, number of pages accessed, number of logins, time spent, and number of worksheets completed. engagement of participants in the human support element of intervention conditions will be evaluated through objective indicators, such as session duration, number of sessions completed, and Session Rating Scale scores, as well as subjective indicators, such as qualitative feedback (e.g. asking participants how engaged they felt during the session). Participants will be contacted by telephone following the release of the booster module (10-weeks post-baseline), to schedule an interview for the purposes of obtaining qualitative feedback on user satisfaction with the guidance (intervention) conditions. Participants who are willing to participate in this interview will then be sent a topic guide (via email) at least 1 week prior to their scheduled interview and will be contacted again at the agreed time for the interview to occur. Interviews will occur over the phone, via videoconferencing (Microsoft Teams), or in-person. Interviews will be audio recorded, and participants will be asked at the conclusion of the interview whether they would like to review their contribution prior to analysis. Those who would like to review their contribution will be sent a password protected word document containing their interview transcript via email and asked to review this within one week of receiving it. Participants may be asked to participate in subsequent interviews until consensus (agreement) has been reached.
Sponsors
Study design
Eligibility
Inclusion criteria
Women (1) 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 will be eligible.
Exclusion criteria
No internet access / active email address, non-English speakers (note: those with English as a second language who have sufficient English-fluency for informed consent and program comprehension are eligible), or previous medical history of dementia.