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

November 13, 2021 updated by: Anders Ringnér, Umeå University

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

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.

Study Overview

Status

Completed

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lund, Sweden
        • Skane University Hospital
      • Umeå, Sweden
        • Umeå University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 to patient education
No Intervention: Control
Standard care as per ward protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Inventory for Parents (compare the mean scoring)
Time Frame: 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.
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)
Time Frame: baseline up to one year post intervention
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)
Time Frame: baseline up to one year post intervention
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)
Time Frame: baseline up to one year post intervention
Seven-point visual-digital scales.
baseline up to one year post intervention
Satisfaction with information (compare the mean scoring)
Time Frame: baseline up to one year post intervention
Seven-point visual-digital scales.
baseline up to one year post intervention
Number of health care contacts
Time Frame: baseline up to one year post intervention
baseline up to one year post intervention
Experiences with your Health Care Provider (compare the mean scoring)
Time Frame: baseline up to one year post intervention
15 items measuring the caring relationship with a health care provider
baseline up to one year post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Anders Ringnér, PhD, Umea University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

December 11, 2014

First Submitted That Met QC Criteria

January 2, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 13, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • PR2013-0086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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