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

Stress Clinical Trial

— PIFBO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332226
• Other study ID #: PR2013-0086
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: January 2020

Study information

• Verified date: November 2021
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Health Knowledge, Attitudes, Practice
• Stress

Intervention

Behavioral:
• Representational approach
Representational approach to patient education

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Lund
Sweden	Umeå University Hospital	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	University of Skövde

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Ringnér A, Karlsson S, Hällgren Graneheim U. A person-centred intervention for providing information to parents of children with cancer. Experiences and effects. Eur J Oncol Nurs. 2015 Jun;19(3):318-24. doi: 10.1016/j.ejon.2014.10.012. Epub 2014 Nov 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impact of Event Scale-Revised (compare the mean scoring)	22 items measuring posttraumatic stress symptoms.	baseline up to one year post intervention
Secondary	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
Secondary	Anxiety and depression (compare the mean scoring)	Seven-point visual-digital scales.	baseline up to one year post intervention
Secondary	Satisfaction with information (compare the mean scoring)	Seven-point visual-digital scales.	baseline up to one year post intervention
Secondary	Number of health care contacts		baseline up to one year post intervention
Secondary	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