Spots Global Cancer Trial Database for The PIFBO-study: Person-centred Information to Parents in Paediatric Oncology

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: The PIFBO-study: Person-centred Information to Parents in Paediatric Oncology

Official Title: The PIFBO-study: Person-centred Information to Parents in Paediatric Oncology - A Randomized Controlled Trial Based Upon a Conceptual Framework for Patient Education

Study ID: NCT02332226

Conditions

Stress

Health Knowledge, Attitudes, Practice

Interventions

Representational approach

Study Description

Brief Summary: The aim of this project is to evaluate a person-centred informational intervention aimed at parents of children with cancer. The following hypotheses will be tested: an informational intervention emanating from the parents' self-identified needs is associated to decreased illness-related parenting stress, decreased post-traumatic stress symptoms, increased received knowledge, decreased anxiety, decreased depression, increased satisfaction with information, and decreased number of health care contacts in parents.

Detailed Description: BACKGROUND Parents of children with cancer have great information needs and report that these are not always met. Psychosocial suffering such as stress and anxiety is also common in this group. INTERVENTION The intervention in this study builds upon the representational approach for patient education. It emanates from Leventhal's theories about illness representation and educational theories about conceptual change. Central elements in the approach are parental choice of information topics of interest, and a thorough assessment of present parental knowledge before information is given. Each parent in the intervention arm gets four sessions with an intervention nurse. DESIGN AND METHODS The study comprises a multi-centre randomized controlled trial with two parallel arms with a 1:1 allocation ratio. One arm will receive the intervention and the other standard care according to local routines at each ward. The effect will be measured with validated instrument which are answered on a web platform. Complementary to the quantitative evaluation, we will perform a process evaluation aiming at understanding the change mechanisms, treatment fidelity, dose delivered, contextual factors of importance and how the intervention further could be optimized.