Ethical concerns when recruiting children with cancer for research: Swedish healthcare professionals' perceptions and experiences.

BACKGROUND: Research is crucial to improve treatment, survival and quality of life for children with cancer. However, recruitment of children for research raises ethical challenges. The aim of this study was to explore and describe ethical values and challenges related to the recruitment of children with cancer for research, from the perspectives and experiences of healthcare professionals in the Swedish context. Another aim was to explore their perceptions of research ethics competence in recruiting children for research. METHODS: An explorative qualitative study using semi-structured interviews with key informants. Seven physicians and ten nurses were interviewed. Interviews were analysed using inductive qualitative content analysis. RESULTS: The respondents' ethical challenges and values in recruitment mainly concerned establishing relationships and trust, meeting informational needs, acknowledging vulnerability, and balancing roles and interests. Ensuring ethical competence was raised as important, and interpersonal and communicative skills were highlighted. CONCLUSION: This study provides empirical insight into recruitment of children with cancer, from the perspectives of healthcare professionals. It also contributes to the understanding of recruitment as a relational process, where aspects of vulnerability, trust and relationship building are important, alongside meeting informational needs. The results provide knowledge on the complexities raised by paediatric research and underpin the importance of building research ethics competence to ensure that the rights and interests of children with cancer are protected in research.

Conducting Digital Health Care Research: Document Analysis of Challenges Experienced During Intervention Development and Feasibility Study Setup of an Internet-Administered Intervention for Parents of Children Treated for Cancer.

BACKGROUND: The design and conduct of research to develop, test, and evaluate complex health care interventions is challenging. Although the existing literature describes key challenges associated with the design and conduct of definitive (evaluation) trials, there is a lack of information concerning specific challenges associated with the intervention development phase and setup of feasibility studies. In particular, the literature is scarce concerning the challenges associated with conducting digital health care research, such as research on internet-administered interventions and research using digital features to support the execution of study procedures (eg, recruitment, consent, retention, and data collection and management). This study is conducted in the context of the intervention development and feasibility study setup phases of an internet-administered, guided, low-intensity cognitive behavioral therapy-based intervention for parents of children previously treated for cancer. OBJECTIVE: The aim of this study is to explore the challenges experienced during the development phase of the internet-administered intervention and digital features to support the execution of the study procedures and a feasibility study setup. METHODS: To explore the key challenges experienced, we conducted a document analysis of written records from all study meetings held by the research team (meeting minutes) between June 7, 2018, and January 10, 2020, guided by a thematic analysis approach. Furthermore, discussion groups with members of the research team were held to develop a more detailed understanding of the key challenges experienced. Methods and results are reported in accordance with the relevant items from the Standards for Reporting Qualitative Research checklist. RESULTS: Six main themes were identified: decision-making and communication, expertise, external constraints, flexibility, planning and scheduling, and technical constraints. CONCLUSIONS: Significant challenges were experienced during the intervention development and setup phases of the feasibility study. Implications are discussed to inform future design, conduct, and planning of internet-administered intervention development and feasibility studies, especially within the context of digital health care research.

The effectiveness of smartphone compassion training on stress among Swedish university students: A pilot randomized trial.

OBJECTIVE: To investigate the effects of a 6-week smartphone compassion training intervention on mental health. METHOD: Fifty-seven Swedish university students (mean age = 25, SD = 5) reporting high levels of stress were randomized to compassion training (n = 23), mindfulness (n = 19), or waitlist (n = 15). RESULT: Multilevel models indicated that both compassion and mindfulness training increased self-compassion compared to the waitlist, while only compassion significantly reduced stress. Between-group effect sizes for compassion compared to waitlist were large for both self-compassion (d = 1.61) and stress (d = 0.94). Compassion and mindfulness did not differ significantly, but effect sizes were in favor of compassion. Secondary outcomes indicated positive effects on emotional awareness, while no effect was found for global psychological distress. CONCLUSIONS: Our results suggest that compassion training via a smartphone application can improve self-compassion and reduce stress among university students. Future studies in larger clinical samples are warranted.

Study within a trial (SWAT) protocol. Investigating the effect of personalised versus non-personalised study invitations on recruitment: An embedded randomised controlled recruitment trial.

INTRODUCTION: Recruitment into clinical trials is a common challenge experienced by healthcare researchers. Currently, there is little evidence regarding strategies to improve recruitment into clinical trials. However, preliminary research suggests the personalisation of study invitation letters may increase recruitment rates. As such, there is a need to investigate the effectiveness of personalisation strategies on trial recruitment rates. This study within a trial (SWAT) will investigate the effect of personalised versus non-personalised study invitation letters on recruitment rates into the host trial ENGAGE, a feasibility study of an internet-administered, guided, Cognitive-Behavioural Therapy (CBT) based self-help intervention for parents of children previously treated for cancer. METHODS: An embedded randomised controlled trial (RCT) will investigate the effectiveness of a personalised study invitation letter including the potential participant's name and address compared with a standard, non-personalised letter without name or address, on participant recruitment rates into the ENGAGE study. The primary outcome is differences in the proportion of participants recruited, examined using logistic regression. Results will be reported as adjusted odds ratios with 95% confidence intervals. DISCUSSION: Even moderate effects of the personalisation of study invitation letters on recruitment rates could be of significant value by shortening study length, saving resources, and providing a faster answer to the clinical question posed by the study. This protocol can be used as a template for other researchers who wish to contribute to the evidence base for trial decision-making, by embedding a similar SWAT into their trial. TRIAL REGISTRATION: ISRCTN 57233429; ISRCTN 18404129; SWAT 112, Northern Ireland Hub for Trials Methodology Research SWAT repository (2018 OCT 1 1231).