Acceptability, fidelity and trial experience of four intervention components to support medication adherence in women with breast cancer: A process evaluation protocol for a pilot fractional factorial trial

Background The Refining and Optimising a behavioural intervention to Support Endocrine Therapy Adherence (ROSETA) programme has developed four intervention components aiming to improve medication adherence in women with early-stage breast cancer. These are (a) text messages, (b) information leaflet, (c) Acceptance and Commitment Therapy-based guided self-help (ACT), (d) side-effect management website. Guided by the Multiphase Optimisation Strategy, our pilot trial will use a fractional factorial design to evaluate the feasibility of undertaking a larger optimisation trial. The pilot will include a process evaluation to maximise learning regarding the fidelity and acceptability of the intervention components before proceeding with a larger trial. The trial process evaluation has three aims: to assess the (1) fidelity and (2) acceptability of the intervention components; and (3) to understand participant’s trial experience, and barriers and facilitators to recruitment and retention. Methods The process evaluation will use multiple methods. Fidelity of the intervention components will be assessed using self-reported questionnaire data, trial data on intervention component adherence, and observations of the ACT sessions. Acceptability of the intervention components and trial experience will be explored using an acceptability questionnaire and interviews with patients and trial therapists. Trial experience will be assessed using a questionnaire and interviews with participants, while barriers and facilitators to recruitment and retention will be assessed using a questionnaire completed by research nurses and participant interviews. The pilot trial opened for recruitment on 20th May 2022 and was open at the time of submission. Conclusions This process evaluation will provide information regarding whether the intervention components can be delivered with fidelity within a national healthcare setting and are acceptable to participants. We will also better understand participant experience in a pilot trial with a fractional factorial design, and any barriers and facilitators to recruitment and retention. Registration ISRCTN registry (ISRCTN10487576, 16/12/2021). Plain English summary The majority of women with early-stage breast cancer are recommended adjuvant endocrine therapy (AET) to reduce the chances of their cancer coming back. Many women given this medication don’t take it every day or stop taking it earlier than they should. We have developed four different interventions to help women take AET. These are; text messages reminding women to take AET; an information leaflet explaining how AET works and its benefits and side-effects; a therapy programme to reduce distress, consisting of five support sessions and four module booklets; and a website with strategies to manage AET side-effects. We are now testing whether these interventions can be delivered within the NHS in different combinations, in a small trial. We have three aims: To find out if the interventions can be given and are received in the way they were supposed to (fidelity). To find out if the support received as part of the trial was acceptable to women with breast cancer (acceptability). To find out what women’s experience was of taking part in the trial overall (trial experience). To do this we will: Interview participants to ask them how acceptable they found the interventions, what they understood, whether they used the interventions, and how they found participating in the trial. Interview therapists who delivered the therapy programme to see if they delivered it as they were supposed to, and how they found delivering the intervention. Ask participants to complete questionnaires about how acceptable the interventions were, and whether they read and used them. Ask the staff involved in finding participants for the trial about challenges and improvements. We will use what we find to make improvements in a future trial where we will test whether the interventions help women to take AET

Avaliação da incidência de antracnose, do desempenho e estado nutricional de variedades de mangueira, para cultivo orgânico, na região centro-norte do Estado de São Paulo.

A mudança do perfil do consumidor, aliada aos riscos da contaminação por agrotóxicos, tem levado à busca de alternativas ecologicamente apropriadas para produção de frutas. Os objetivos deste trabalho foram avaliar a incidência de antracnose, o desempenho e estado nutricional de variedades de mangueira conduzidas organicamente na região de Pindorama-SP. Foram utilizadas 17 variedades de mangueira. O experimento foi instalado em delineamento experimental em blocos completos ao acaso, com 17 tratamentos (variedades) e seis repetições. Foi avaliada a severidade de antracnose nas folhas, através de uma escala diagramática, atribuindo-se notas aos sintomas. Foram avaliados o crescimento e o desenvolvimento (altura da planta, perímetro do tronco e da copa) e o estado nutricional, mediante análise foliar, das diferentes variedades utilizadas. Através dos resultados obtidos, podem-se considerar como muito suscetíveis à antracnose as variedades Bourbon, Rocha e Rosa; e resistentes, as variedades IAC 111, Alfa, Beta e Parvin; as variedades de manga apresentaram o mesmo padrão de crescimento; as maiores alturas da planta corresponderam aos maiores diâmetros do tronco e da copa; a variedade Parvin apresentou o melhor desempenho dentre as variedades estudadas, com relação à resistência à antracnose, altura e diâmetro do caule e da copa, podendo ser recomendada ao cultivo orgânico. As variedades Omega e Alfa também apresentaram bom crescimento, podendo ser indicadas para esse cultivo, pelo menos nessa fase inicial; as variedades Surpresa e Rosa não apresentaram bom desempenho, no campo, em relação às demais, não devendo ser recomendadas para o cultivo orgânico, principalmente a variedade Rosa, bastante suscetível à antracnose. As concentrações de N, P e K foram elevadas na fase vegetativa das plantas, comparadas à baixa concentração de Ca; houve carência de Boro em todas as variedades estudadas. A manga Rosa, provavelmente, sofreu toxicidade ao excesso de manganês, ocasionando diminuição em seu desenvolvimento