None listed
Conditions
Brief summary
The purpose of this study is to implement and evaluate The Enhancing Women’s Recovery after Cancer Treatment Program (known as RECENTRE) as standard practice after treatment, Queensland-wide, across Mater Misercordiae facilities. RECENTRE is a digitally enabled lifestyle program for prevention of additional chronic disease in women treated for breast and gynaecological cancer. Who is it for? You may be eligible for this study if you are a female who has been diagnosed with breast or gynaecological cancer, that has completed intensive cancer treatment more than 4 weeks ago. Study details In this study, all participants receive the 12-week RECENTRE intervention targeting physical activity, diet, alcohol management, body weight, smoking cessation, sleep, stress, menopausal symptoms, and sexual health. These strategies are personalised based on individual goals and functional capacities. The RECENTRE program involves online modules and virtual consultations, if required. Participants will be followed up for 6 months, and asked to complete questionnaires throughout the study to follow-up on overall health. It is hoped that this study will help determine if the RECENTRE program is an effective and safe way to provide support to women after cancer treatment.
Interventions
RECENTRE is a single-cohort implementation study; hence, all participants receive the intervention. The 12-week digital intervention targets health education and health promotion incorporating international recommendations for the core outcomes of physical activity, diet, and minimising alcohol and body weight management as well as evidence-based strategies to manage smoking cessation, sleep, stress, menopausal symptoms, and sexual health over a 12-week period. Physical activity recommendations align with Australia’s physical activity and exercise guidelines for all Australians whilst accounting for sedentary behaviour guidelines and World Cancer Research Fund cancer prevention guidelines. For example to be moderately physically active, equivalent to brisk walking, for greater than or equal to 30 minutes daily. As fitness improves, aim for greater than or equal to 60 minutes of moderate (or for greater than or equal to 30 minutes of vigorous) physical activity every day and to be as lean as possible within the healthy weight range. Dietary recommendations include: eat mostly foods of plant origin; limit consumption of energy dense foods; avoid sugary drinks; limit intake of red meat and avoid processed meat; and avoid alcohol consumption. These are based on several guidelines including those from the Australian Dietary Guidelines, World Cancer Research Fund and the American Institute for Cancer Research. All other recommendations have been clinically informed by experts in the field of cancer recovery. Participants are provided the content firstly on a day-to-day basis (weeks 1-3) and then weekly (weeks 4-12) to build on, expand, revisit and reflect on knowledge gained. The timing and application of these strategies reflect the life stage of these women and are personalized to meet their individual goals and functional capacities. A baseline needs assessment assists participants to identify areas of priority and focus whilst working through the intervention content (accessing or omitting content relevant to personal preference and at a frequency of their choosing). Time taken to complete each section will vary from person to person depending on the content they choose, but we anticipate on average participants will spend an average of one-2 hours per week over the course of the 12 weeks to complete the full content available including completion of their RECENTRE Wellbeing Journal and RECENTRE thermometer. Reflections and a mid-program needs assessment helps to realign goals and priorities with the aim to build self-efficacy for personalised long-term health management. Additional customisation is offered to participants assessed as requiring additional support (i.e. advancer cancer, distressed) and by way of personalised virtual nurse specialist consultations. The content (covering but not limited to topics noted above) will be delivered individually via a self-directed interactive online platform. Participants flagged as requiring additional in-person support will be identified the needs assessments as well as via completion of three-weekly RECENTRE thermometers embedded in the intervention Wellbeing Journal. The RECENTRE thermometer is a single visual analogue scale (scores range 0 – 10) that essentially ‘flags’ if the participant is experiencing distress and or need, and therefore requires additional support from a clinical team member. Any participant identified as having advanced cancer at baseline will be offered additional clinical support for the duration of the intervention (maximum three consultations) and referral to appropriate clinical Associate Investigators based at Mater, if required. Each participant requiring additional in-person support will be offered individual virtual clinical consultations with trained clinicians via Zoom, Teams, FaceTime, or telephone to tailor their lifestyle program, and motivate them towards goal achievement, self-management, and a sustainably healthy lifestyle. The RECENTRE program provides all necessary health promotion content and supports participants to log relevant health and lifestyle information into the Wellbeing Journal, which is populated with responses to activities over time. The participant start date triggers a progression bar which is also displayed within the Wellbeing Journal. A weekly physical activity planner encourages participants to plan for their physical activity in the following week. The intervention platform incorporates news and announcements; new evidence; an overview of the program; and an online moderated ‘community’, programmed and monitored by RECENTRE clinical and technical teams, that allows participants to communicate with each other and ask basic questions relating to RECENTRE. Security of information entered by participants is ensured through encrypted data transmission and secure storage. The website and digital intervention is adapted for all computing platforms, including mobile phones however for ease of use the module content and updating of the Wellbeing Journal is best completed using a larger screen. Consultations (if required) with a nurse specialist trained in the intervention and with expertise in supportive cancer care will be conducted via video- or teleconferencing and will last approximately one hour. Therefore participants can undertake this study from their own homes or anywhere comfortable to them where they can access a Wi-Fi connection and privacy. In keeping with privacy guidelines, no recording of the consultations is undertaken.
Sponsors
Study design
Eligibility
Inclusion criteria
• Confirmed diagnosis of breast or gynaecological cancer (all stages). • Have completed intensive cancer treatment more than 4 weeks ago including surgery, chemotherapy, immunotherapy and/or radiotherapy (maintenance therapy as specified by treating team permitted e.g. oral chemotherapy; targeted therapies for example trastuzumab; endocrine therapy; bisphosphonates) and up to 36 months post-intensive treatment. • >18 years of age. • Received care through any Mater facility. • Are residing in Queensland, Australia. • Cognitively capable of consent. • Have access to the internet with a stable connection. • Own, or have access to, a computer, tablet device or smartphone. • Willing and able to comply with all study requirements, including intervention, timing, and nature of required assessments. • Able to speak and read in English to ensure consent is informed and documentation of participant-reported outcome measures can be adhered to. • Voluntary written (electronic) informed consent.
Exclusion criteria
• Those who do not fit the above inclusion criteria. • Women who are palliative, or on intensive treatment and/or unlikely to be able to complete the program, or unable to provide informed consent. • Any clinical contraindication that precludes safe completion of the program in the judgement of the project team