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

Umeå University

Status: Completed

Conditions: Health Knowledge, Attitudes, Practice; Stress

Treatments: Behavioral: Representational approach

Study type: Interventional

Funder types: Other

Identifiers

NCT02332226

PR2013-0086

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups

Representational approach

Experimental group

Description:

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.

Treatment:

Behavioral: Representational approach

Control

No Intervention group

Description:

Standard care as per ward protocol.