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NCT02332226 | COMPLETED | Stress


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

Umeå University

Information provided by (Responsible Party):

Anders Ringnér

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.

Condition or disease

Stress

Health Knowledge, Attitudes, Practice

Intervention/treatment

Representational approach

Phase

NA

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
Estimated Enrollment : 32 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
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
Actual Study Start Date : 2015-01
Estimated Primary Completion Date : 2019-07
Estimated Study Completion Date : 2020-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

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

Location Details

NCT02332226


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Sweden,

Skåne University Hospital

Lund, Sweden,

Not yet recruiting

Sweden,

Umeå University Hospital

Umeå, Sweden,

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