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.

Exploring the Potential of a Pretend Play Intervention in Young Patients With Leukemia.

PURPOSE: The aims of the study are 1) to gain knowledge of parents' and professionals' perceptions about cancer stricken children's resources, burdens, and ability to pretend play, and 2) to prepare the initiation of a pretend play intervention based on children's needs and included parents' and professionals' feedback. DESIGN AND METHODS: Qualitative design using semi-structured interviews with 13 parents of children diagnosed with leukemia and 15 professionals in the field of pediatric oncology. Themes were derived with content analysis via deductive and inductive coding. RESULTS: Analysis resulted in five topics. (1) Ability to play in the context of leukemia (2) ways of coping with leukemia (3) difficulty in transition to normality (4) parental quality of life and parents' needs (5) perceptions of the potential of pretend play. CONCLUSION: Study results indicate the potential of pretend play interventions for young cancer patients and the need for additional professional support of parents. PRACTICE IMPLICATIONS: Pretend play is a tool children carry with them regardless of their circumstances. If we can enhance their ability to play, doing so should give them an advantage in creative problem solving and creative expression as they deal with a life threatening disease.

Parent Perceptions of a Pretend Play Intervention for Their Children With Cancer.

BACKGROUND: Although the rate of survival in childhood cancer today is close to 85%, a cancer diagnosis can still turn the world upside down for both children and parents. Often, children in oncology care are frustrated about their inability to control events and activities around them. Therapeutic pretend play has been suggested as a means to encourage children to express and handle emotions in a safe environment. PURPOSE: This study was developed to describe and explore parents' experiences of a pretend play intervention that consisted of six to eight play sessions with a play facilitator administered to their children undergoing cancer treatment. METHODS: A descriptive qualitative method was used, including individual interviews with 15 parents. RESULTS: Three main categories were developed, including (a) experiences of joining the project, (b) perceptions of the play intervention, and (c) reflections on effects and implications, with subcategories evolved for each category. The parents experienced that the play sessions helped improve their children's communication skills and made them more capable of participating in their care. They appreciated that the intervention focused on the child's well-being and saw it as a positive break in their child's cancer treatment. It also helped them better reflect on their own situation. CONCLUSIONS/IMPLICATIONS FOR PRACTICE: According to the parents' experiences, pretend play can be a helpful tool for improving children's participation in their cancer care that strengthens their autonomy, emotional repertoire, and communication skills. However, the results also highlighted that some of the children did not fully understand the information provided about this study, which weakened the validity of their consent to participate. Thus, more work is needed on developing age-appropriate information to obtain participation consent from children. In addition, more knowledge is needed regarding how to appropriately include children with cancer in research in an ethically acceptable way.

Effects of a Pretend Play Intervention on Health-Related Quality of Life in Children With Cancer: A Swedish-German Study.

Background: Cancer diagnosis can lead to massive physical, emotional, and social burdens on children and their families. Although children have the right to be informed and participate in their care, research shows that children's views are often not considered in care situations. Thus, it is essential to strengthen children's communication and self-efficacy (SE) to convey desires and needs. The present study explores whether a play intervention is associated with improved health-related quality of life (HrQoL) and SE for communication in care situations. We hypothesize that HrQoL and SE for communication will increase from the beginning to after the pretend play intervention. Methods: Children with cancer from Germany and Sweden were enrolled. The pretend play intervention consisted of six to 10 play sessions. A heterogenic selection of questionnaires was used to measure children's HrQoL and SE before the first pretend play session and after the last play intervention. Results: Nineteen families were included in the presented analyses, including 14 self-reports of children and 19 proxy reports of parents. We found improvements in child-reported communication, and emotional and psychosocial well-being using generic and cancer-specific HrQoL measurements. Further, children's SE in care situations improved during the play intervention. Parents also reported minor improvements in the physical dimensions in both generic and chronic-generic HrQoL, along with improvements in independence. Discussion: Overall, the cancer-specific pretend play intervention offers young children with cancer a secure environment and can contribute to their well-being, and communication skills, during or after cancer treatment.

Development, preliminary validation and reliability testing of SEDA - Self-Efficacy in Daily Activities for children with pain.

Background: Self-efficacy can affect a child's ability to perform important activities, infuse him/her with a sense of control and is likely an integral target for successful treatment in pediatric pain rehabilitation. Modern physical therapy treatment includes behavioral aspects and valid measures of self-efficacy are important for both research and clinical practice. In this study, the aim was to develop and perform preliminary testing of a self-efficacy scale for children and adolescents with pain.Methods: Children and adolescents participated, along with researchers and healthcare staff, in developing the Self-Efficacy in Daily Activities (SEDA) measure. A total of 109 children and adolescents seeking physical therapy treatment for pain lasting longer than 3 months responded to the SEDA. Pain and pain-related disability were assessed using the Functional Disability Inventory (FDI). Exploratory analyzes for testing validity and reliability - principal component analyses (PCA), intraclass correlation coefficients (ICCs) and bivariate correlations - were performed.Results: The PCA revealed a 16-item SEDA and a three-component scale. The components represented self-efficacy for physical activities, self-efficacy for personal care and self-efficacy for daily exertion. Validity correlation analyses showed moderate association between SEDA and FDI, -0.72 (p < .01), and low correlation with pain intensity, -0.29 (p = .03).Conclusions: The 16-item SEDA has satisfactory psychometric properties in children moderately affected by long-term pain. Further validation of the SEDA in other populations and confirmatory analyses are warranted.

Physical therapists' experiences of learning and delivering a complex behavioral medicine intervention to adolescents with pain.

The objective was to study physical therapists' (PTs') experiences of learning and delivering a complex intervention, a tailored behavioral medicine treatment (BMT) targeting adolescents with pain in primary care.Method: An explorative study with qualitative approach, using content analysis. Three primary care PTs delivering the treatments in a randomized controlled study were interviewed regarding their views on the BMT.Results: The participating PTs considered learning about and delivering the BMT as challenging but rewarding. The biopsychosocial approach, tailoring of the treatment and dialogues with parents were identified as key aspects of the BMT program. The process of formulating a functional behavioral analysis was perceived as strenuous. The supervision of the PTs throughout the study was regarded as crucial and necessary for learning about and providing tailored BMT.Conclusion: Learning about and delivering BMT targeting adolescents with persistent pain is fruitful but laborious and demanding according to three PTs experienced with treatment of pediatric pain in primary care. Extensive education and long periods of supervision seem to be crucial for success and safe delivery according to protocol.

Balancing scientific interests and the rights of participants in designing a recall by genotype study.

Recall by genotype (RbG) studies aim to better understand the phenotypes that correspond to genetic variants of interest, by recruiting carriers of such variants for further phenotyping. RbG approaches pose major ethical and legal challenges related to the disclosure of possibly unwanted genetic information. The Cooperative Health Research in South Tyrol (CHRIS) study is a longitudinal cohort study based in South Tyrol, Italy. Demand has grown for CHRIS study participants to be enrolled in RbG studies, thus making the design of a suitable ethical framework a pressing need. We here report upon the design of a pilot RbG study conducted with CHRIS study participants. By reviewing the literature and by consulting relevant stakeholders (CHRIS participants, clinical geneticists, ethics board, GPs), we identified key ethical issues in RbG approaches (e.g. complexity of the context, communication of genetic results, measures to further protect participants). The design of the pilot was based on a feasibility assessment, the selection of a suitable test case within the ProtectMove Research Unit on reduced penetrance of hereditary movement disorders, and the development of appropriate recruitment and communication strategies. An empirical study was embedded in the pilot study with the aim of understanding participants' views on RbG. Our experience with the pilot study in CHRIS allowed us to contribute to the development of best practices and policies for RbG studies by drawing recommendations: addressing the possibility of RbG in the original consent, implementing tailored communication strategies, engaging stakeholders, designing embedded empirical studies, and sharing research experiences and methodology.

Pretend Play as an Intervention for Children With Cancer: A Feasibility Study.

Children with cancer suffer from symptoms and burdensome treatments that often cause distress to children and their families. Mortality is one aspect of cancer diagnosis, while another is the quality of life and well-being during and after the treatment. By supporting children's communication, self-efficacy and coping ability in the care situation, children are given the possibilities for increased independence and participation and are allowed to develop an influence over their care. The aim of this study was to develop and evaluate the feasibility and acceptability of an adult-facilitated pretend play intervention for children with cancer. Five children with ongoing treatment for cancer were invited to a play intervention that consisted of six to eight sessions of structured pretend play aimed at increasing participation, independence, and well-being. A mixed method design was used to evaluate the feasibility and acceptability of the play intervention. Measures were collected before and after interventions, and in conjunction with every play session. Results suggest that the children enjoyed the play intervention. Findings indicate small improvements regarding self-efficacy in care situations and equal or increased quality of life for participants. A main finding was that no adverse events or increased worrying was reported in conjunction with play sessions. Therefore, the intervention is regarded as safe, feasible, and acceptable as reported by participants and their primary caregivers and a possible means of increasing participation and independence in children with a cancer diagnosis.