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

Not Applicable

Completed

• Conditions: Health Knowledge, Attitudes, Practice; Stress
• Interventions: Behavioral: Representational approach

• Registration Number: NCT02332226
• Lead Sponsor: Umeå University

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.

Study Timeline

• Study First Submitted: 2014-12-11
• Study Start: 2015-01
• Study First Submitted QC: 2015-01-02
• Study First Posted: 2015-01-06
• Primary Completion: 2019-07
• Study Completion: 2020-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-13
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Being a parent of a child that

1. is diagnosed with a first time occurrence of a malignancy that is curatively treated and

2. was diagnosed two months ago.

   Further parents must be

3. able to talk, read and write Swedish enough to be able to participate without an interpreter.

Exclusion Criteria

• None specific.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Representational approach	Representational approach	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Umeå University Hospital; 🇸🇪 Umeå, Sweden

Skåne University Hospital; 🇸🇪 Lund, Sweden