Community Implementation of the ‘Cascade’ (Cope, Adapt, Survive: life after CAncEr) online program for parents of child, adolescents and young adult (AYA) cancer survivors A Phase-III Trial.

"Cascade". This study is an implementation study, and therefore we may refer to the study as the "Cascade implementation study", and the clinical intervention portion of the study the "Cascade intervention" No evidence based, equitable community-delivered programs exist to provide skills-based support for parents of children, adolescents and young adult (AYA) cancer survivors. The Cascade implementation study aims to build on research on theoretically grounded online interventions for parents of child and AYA cancer survivors by teaching adaptive cognitive-behavioural coping skills to promote resilience in early survivorship. Previous research indicates that the Cascade program is acceptable, feasible and clinically safe for parents, and suggest that the intervention may stabilize parents’ fear of cancer recurrence. Also, similar previous online interventions have demonstrated that the online format is an acceptable way to deliver group-based interventions to members of rural and remote families in Australia. The current project – the Cascade implementation study - has dual aims: (1) To evaluate the clinical effectiveness of the Cascade program in providing an avenue for peer support and teaching CBT and coping skills among parents of child and AYA cancer survivors (aged up to 25 years) when delivered in a community setting. (2) To evaluate the implementation of the Cascade program in community cancer support setting(s). Factors including intervention fidelity, participant recruitment and retention, reach/organizational uptake, and financial sustainability will be assessed. The Cascade program is designed to be easily integrated into programs already offered by community organisations, and to be easily accessible to both metropolitan and rural families in Australia. Regarding study materials, parent participants will receive a written manual summarising the weekly home practice activities. Intervention providers (also treated as participants – henceforth “facilitators”) will participate in several workshops that instruct on how to deliver the Cascade intervention to parents over online videoconferencing software. Additionally, facilitator participants will receive a manual covering in detail how to deliver each module of the Cascade intervention. The process of implementation of the Cascade intervention at any given community organisation can be outlined as a series of stages. Over the course of the Cascade implementations study, we expect to work with several community organisations, and it may therefore be the case that different organisations will be at different stages of implementation at any one time. See below for a stage-wise breakdown of the Cascade implementation study: a. Planning and consultation – The lead study team will consult with management staff at each community organisation to organise infrastructure, personnel, training, and advertising of the Cascade intervention b. Advertising and recruitment – The Cascade intervention will be advertised to our target consumer base on social media platforms. Also, referrals may be received from counselling staff within the community organisation and staff from other relevant clinical services around Australia c. Consent – Informed consent will be obtained from all participants via Qualtrics d. Intake – Parent participants will complete a brief telephone intake call to confirm eligibility, obtain consumer details, assess risk, and obtain the details of a trusted healthcare professional and of another support-person. Parents complete a baseline questionnaire (Q1) and receive a written manual of Cascade session content at roughly this time. e. Introductory session – After group allocation, parent participants will complete a one-on-one online session with the group facilitator to troubleshoot technical issues, allow the facilitator to build rapport, and provide opportunity for the parent participant to set personalised goals for the program. This will take approximately 20 minutes. f. Treatment - Following the introductory session, parents will complete four weekly online group sessions, with each focussing on a specific module. Modules are ordered as following: psychoeducation and health (behavioural activation); appraisal (unhelpful thinking styles); mindfulness and disengagement; social support (assertiveness). Each 90-minute module focusses on applying CBT techniques to areas of concern specific to parents of child and AYA cancer survivors. Tailored supportive counselling is used in all Cascade sessions, and empathic listening is used to normalise the range of parent experiences and promote peer discussion/support. Home practice is encouraged for parent participants, with practice exercises and examples in the provided manual. g. Booster session - One week after the end of Module 4, parent participants will complete a one-on-one booster session with their group facilitator to review and consolidate skills learnt across the program, receive additional input from the facilitator, and discuss how to apply these skills to new challenges that may have arisen since finishing their program. The facilitator will also follow up with the goal outlined by the parent participant in the initial introduction session. Participants will complete a second questionnaire (Q2) one to four weeks after completion of the booster session. The booster session will take 10-60 minutes. Intervention providers for Cascade will be community organisation staff members trained in the delivery of Cascade. Intervention training will consist of 2x half-day workshops and be comprised of experiential and adaptation sessions. Training sessions will take place during planning and consultation with community organisations – approximately 3 months prior to intervention commencement. Facilitators will be registered healthcare professionals (including but not limited to psychologists, clinical psychologists, counsellors, and nurses), or students completing clinical training under supervision of a registered healthcare professional. The Cascade intervention will be delivered to parent participants via online videoconferencing. This will involve third-party videoconferencing clients (e.g. Zoom, WebEx, etc.) The Cascade intervention is designed to be delivered as a group intervention, with module content tailored around shared engagement. Only the Introductory session and Booster session will be delivered as a one-on-one session between the facilitator and parent participant. As the Cascade intervention is designed to be delivered online in a group videoconferencing format – therefore infrastructure requirements are minimal. Facilitators will make use of remote counselling tools made available by their community organisations. Parent participants will require access to a computer/tablet/mobile with a webcam and microphone and will need a quiet and private space in which to participate in online videocalls for the four-week period of the Cascade intervention. This private space is expected to be in the parent participants’ home but can practically be anywhere that is private and quiet. Given the spontaneous nature of group interventions, facilitators will be expected to adapt the program on the fly, if their clinical judgement deems that certain aspects of the program require more or less emphasis than stated in the manual. Facilitators will adapt the program while delivering the Cascade group modules. Additionally, prior to group sessions, parent participants will be given the opportunity to provide their own goals and expectations for the program. Facilitators are expected to utilise their clinical experience and judgement to modify the content of the group modules as they see fit. Details on how program adaptation will be recorded are provided below. Cascade is designed as a hybrid implementation-effectiveness study. Assessment of program fidelity is a critical part of this research. Facilitators will collect data in the form of process notes. Facilitators will be provided with a template for each session, where they will note the extent to which each topic was covered, the level of parent participant engagement, and if any technical or other issues occurred which were an obstacle to running through the intervention.