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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress, Health Knowledge, Attitudes, Practice

Intervention / Treatment
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* Behavioral: Representational approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being a parent of a child that is diagnosed with a first time occurrence of a malignancy that is curatively treated and was diagnosed two months ago. Further parents must be able to talk, read and write Swedish enough to be able to participate without an interpreter. Exclusion Criteria: None specific.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Representational approach<br>Four sessions with a nurse. For each session, the parent identifies an area where he/she needs more information. The nurse and the parent jointly survey the parent's knowledge of the area and discusses consequences of knowledge gaps or misunderstandings. Then, new information is introduced and benefits from the new information is discussed. | Behavioral: Representational approach<br>* Representational approach to patient education<br>|
| No Intervention: Control<br>Standard care as per ward protocol. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Inventory for Parents (compare the mean scoring) | An instrument with 42 items measuring both frequency and intensity of stressors related to having a chronically ill child. | baseline up to one year post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Event Scale-Revised (compare the mean scoring) | 22 items measuring posttraumatic stress symptoms. | baseline up to one year post intervention | 
| Kowledge expectations of significant others and Received knowledge of significant others (compare the mean scorings) | Two instruments measuring 40 areas of knowledge with respect to expectations and fulfilment. | baseline up to one year post intervention | 
| Anxiety and depression (compare the mean scoring) | Seven-point visual-digital scales. | baseline up to one year post intervention | 
| Satisfaction with information (compare the mean scoring) | Seven-point visual-digital scales. | baseline up to one year post intervention | 
| Number of health care contacts |  | baseline up to one year post intervention | 
| Experiences with your Health Care Provider (compare the mean scoring) | 15 items measuring the caring relationship with a health care provider | baseline up to one year post intervention |