Clinical trial NCT02332226: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Health Knowledge, Attitudes, Practice
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: University of Skövde
First posted: 2015-01-06
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pediatric Inventory for Parents (compare the mean scoring)
timeFrame: baseline up to one year post intervention
Secondary outcomes:
measure: Impact of Event Scale-Revised (compare the mean scoring)
timeFrame: baseline up to one year post intervention
measure: Kowledge expectations of significant others and Received knowledge of significant others (compare the mean scorings)
timeFrame: baseline up to one year post intervention
measure: Anxiety and depression (compare the mean scoring)
timeFrame: baseline up to one year post intervention
measure: Satisfaction with information (compare the mean scoring)
timeFrame: baseline up to one year post intervention
measure: Number of health care contacts
timeFrame: baseline up to one year post intervention
measure: Experiences with your Health Care Provider (compare the mean scoring)
timeFrame: baseline up to one year post intervention
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
affiliation: Umeå University
name: Anders Ringnér, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ringner A, Karlsson S, Hallgren 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.
citation: Ringner A, Bjork M, Olsson C, Graneheim UH. Person-centred information to parents in paediatric oncology (the PIFBO study): A study protocol of an ongoing RCT. BMC Nurs. 2015 Dec 21;14:69. doi: 10.1186/s12912-015-0120-8. eCollection 2015.