Search

Aim: To develop processes for the development of decentralised clinical trial methodology for Aotearoa New Zealand, focussing on equity of access to cancer clinical trials for Māori, Pacific people, vulnerable communities and those in rural settings., Methods: A national steering committee supported by Te Aho o Te Kahu - Cancer Control Agency was formed to: guide the adaptation and implementation of overseas decentralised clinical trial models to suit the needs of Aotearoa New Zealand with an equity focus; provide high-level oversight and expertise for direction and development of policies, procedures and infrastructure compliant with ICH GCP R2; and implement a national strategy., Results: Twelve standard operating procedures were developed, as well as a supervision plan and a glossary. These were made freely available on the New Zealand Association of Clinical Research website., Conclusion: Decentralised clinical trials offer a novel method of trial conduct that is patient- and whānau-centred. The model allows patients to remain in their local area with whānau and support networks, and their local treating team, increasing clinical trial accessibility and quality of care. This methodology has the potential to support improvement in research capabilities nationally and be utilised beyond oncology. It would benefit from significant investment in national clinical trial infrastructure., Competing Interests: Nicola J Lawrence received support from Te Aho o Te Kahu for a project manager for this work and is is co-lead of the New Zealand DCT committee. Marina Dzhelali is a New Zealand Association of Clinical Research board member. Ngapei Ngatai received support from CTNZ for this manuscript. Alvin Tan is director at SalutisCare. Michelle Wilson received support from Te Aho o te Kahu for a project manager for this work and is co-lead of the New Zealand DCT committee., (© PMA.)

Background: Younger women (defined as those < 50 years who are likely pre-menopausal at time of diagnosis) with breast cancer often experience persistent treatment-related side effects that adversely affect their physical and psychological wellbeing. The Women's Wellness After Cancer Program (WWACP) was adapted and piloted in Australia to address these outcomes in younger women. The aims of this feasibility study are to determine (1) the potential to translate the Younger WWACP (YWWACP) intervention to a broader population base in Aotearoa/New Zealand and Australia, and (2) the potential for success of a larger, international, phase ΙΙΙ, randomised controlled trial., Methods: This bi-national, randomised, single-blinded controlled trial involves two main study sites in Aotearoa/New Zealand (Kōwhai study) and Australia (EMERALD study). Young women aged 18 to 50 years who completed intensive treatment (surgery, chemotherapy, and/or radiotherapy) for breast cancer in the previous 24 months are eligible. The potential to translate the YWWACP to women in these two populations will be assessed according to several feasibility outcomes. These include examining intervention accessibility, acceptability and uptake; intervention sustainability and adherence; the prevalence components of the intervention in the control group; intervention efficacy; participants' perception of measurement burden; the effectiveness of planned recruitment strategies; and trial methods and procedures. The studies collectively aim to enrol 60 participants in the intervention group and 60 participants in the control group (total = 120 participants)., Discussion: Ethical approval has been received from the Southern Health and Disability Ethics Committee (Kōwhai ref: 19/STH/215), and UnitingCare Human Research Ethics Committee (EMERALD ref: 202103). This study will provide important data on the feasibility of the refined YWWACP in the trans-Tasman context. This study will account for and harmonise cross-country differences to ensure the success of a proposed international grant application for a phase ΙΙΙ randomised controlled trial of this program to improve outcomes in younger women living with breast cancer., Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): Kōwhai ACTRN12620000260921 , registered on 27 February 2020. EMERALD ACTRN12621000447853 , registered on 19 April 2021., (© 2022. The Author(s).)

This review discusses the personalised dietary approach with respect to inflammatory bowel disease (IBD). It identifies gene-nutrient interactions associated with the nutritional deficiencies that people with IBD commonly experience, and the role of the Western diet in influencing these. It also discusses food intolerances and how particular genotypes can affect these. It is well established that with respect to food there is no "one size fits all" diet for those with IBD. Gene-nutrient interactions may help explain this variability in response to food that is associated with IBD. Nutrigenomic research, which examines the effects of food and its constituents on gene expression, shows that-like a number of pharmaceutical products-food can have beneficial effects or have adverse (side) effects depending on a person's genotype. Pharmacogenetic research is identifying gene variants with adverse reactions to drugs, and this is modifying clinical practice and allowing individualised treatment. Nutrigenomic research could enable individualised treatment in persons with IBD and enable more accurate tailoring of food intake, to avoid exacerbating malnutrition and to counter some of the adverse effects of the Western diet. It may also help to establish the dietary pattern that is most protective against IBD.