The PIFBO-study: Person-centred Information to Parents in Paediatric Oncology
NCT ID: NCT02332226
Last Updated: 2021-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2015-01-31
2020-01-31
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Representational approach
Representational approach to patient education
Control
Standard care as per ward protocol.
No interventions assigned to this group
Interventions
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Representational approach
Representational approach to patient education
Eligibility Criteria
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Inclusion Criteria
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
ALL
No
Sponsors
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University of Skövde
OTHER
Umeå University
OTHER
Responsible Party
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Anders Ringnér
PhD, Senior lecturer
Principal Investigators
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Anders Ringnér, PhD
Role: PRINCIPAL_INVESTIGATOR
Umeå University
Locations
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Skåne University Hospital
Lund, , Sweden
Umeå University Hospital
Umeå, , Sweden
Countries
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References
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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.
Ringner A, Bjork M, Olsson C. What Was on the Parents' Minds? Changes Over Time in Topics of Person-Centred Information for Mothers and Fathers of Children with Cancer. Compr Child Adolesc Nurs. 2023 Jun;46(2):114-125. doi: 10.1080/24694193.2023.2168790. Epub 2023 Feb 22.
Ringner A, Bjork M, Olsson C. Effects of Person-Centered Information for Parents of Children With Cancer (the PIFBO Study): A Randomized Controlled Trial. J Pediatr Hematol Oncol Nurs. 2023 Nov-Dec;40(6):400-410. doi: 10.1177/27527530221115860. Epub 2023 Feb 2.
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.
Other Identifiers
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PR2013-0086
Identifier Type: -
Identifier Source: org_study_id