- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02332226
The PIFBO-study: Person-centred Information to Parents in Paediatric Oncology (PIFBO)
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lund, Sweden
- Skane University Hospital
-
Umeå, Sweden
- Umeå University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Being a parent of a child that
- is diagnosed with a first time occurrence of a malignancy that is curatively treated and
was diagnosed two months ago.
Further parents must be
- able to talk, read and write Swedish enough to be able to participate without an interpreter.
Exclusion Criteria:
- None specific.
Study Plan
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Anders Ringnér, PhD, Umea University
Publications and helpful links
General Publications
- 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, 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...Enrolling by invitationStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
University of PadovaRecruitingStress | Stress Disorder | Work Related StressItaly
-
Duquesne UniversityUniversity of California, San Diego; West Penn Allegheny Health System; El Centro... and other collaboratorsTerminated
-
University of Sao PauloCompleted
-
Syracuse VA Medical CenterUS Department of Veterans AffairsCompletedEmotional Stress | Psychological Stress | Life StressUnited States
-
Dana-Farber Cancer InstituteEnrolling by invitationStress | Post Traumatic Stress Disorder | Work Related StressUnited States
-
Taichung Veterans General HospitalUnknown
-
Royal Cornwall Hospitals TrustEnrolling by invitationStress | Stress, Psychological | Stress, JobUnited Kingdom
-
Northumbria UniversityVolac International LtdNot yet recruitingStress | Mood | Physiological Stress
Clinical Trials on Representational approach
-
Umeå UniversityCompletedStress | Health Knowledge, Attitudes, PracticeSweden
-
University of Sao Paulo General HospitalUniversity of Campinas, BrazilUnknown
-
Sahlgrenska University Hospital, SwedenVastra Gotaland RegionRecruitingMuscle Weakness | Muscle Atrophy | Hip Osteoarthritis | Arthroplasty Complications | Muscle InjurySweden
-
Iuliu Hatieganu University of Medicine and PharmacyEmergency County Hospital Cluj-NapocaCompleted
-
Florida Orthopaedic InstituteOrthopaedic Trauma AssociationCompletedTibial FracturesUnited States
-
Medacta USAMedacta International SACompletedOsteoarthritisUnited States
-
Seoul National University Bundang HospitalCompletedArthroplasty, Replacement, HipKorea, Republic of
-
Sorlandet Hospital HFUnknown
-
Fraser Orthopaedic Research SocietyCompletedINfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia (INSURT)Tibial Fractures | Anterior Knee Pain SyndromeCanada, Spain
-
Cairo UniversityCompletedFacial Nerve Injuries | Subcondylar Process of Mandible Open FractureEgypt