StressPIFBONCT02332226
The PIFBO-study: Person-centred Information to Parents in Paediatric Oncology
A study testing Representational approach in people with Stress and Health Knowledge, Attitudes, Practice, run by Umeå University at 2 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stress, Health Knowledge, Attitudes, Practice
- What is being tested?
- Representational approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2015to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None specific.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Stress, Health Knowledge, Attitudes, Practice
- Being tested
- Representational approach
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Representational approachBehavioural
Representational approach to patient education
| Study group | Role | What they receive |
|---|---|---|
| Representational approach | Experimental | 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. Receives: Behavioral: Representational approach |
| Control | No intervention | Standard care as per ward protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Inventory for Parents (compare the mean scoring)
An instrument with 42 items measuring both frequency and intensity of stressors related to having a chronically ill child.
Measured: baseline up to one year post intervention
Secondary outcomes (6)
Impact of Event Scale-Revised (compare the mean scoring)
22 items measuring posttraumatic stress symptoms.
Measured: baseline up to one year post intervention
Kowledge expectations of significant others and Received knowledge of significant others (compare the mean scorings)
Two instruments measuring 40 areas of knowledge with respect to expectations and fulfilment.
Measured: baseline up to one year post intervention
Anxiety and depression (compare the mean scoring)
Seven-point visual-digital scales.
Measured: baseline up to one year post intervention
Satisfaction with information (compare the mean scoring)
Seven-point visual-digital scales.
Measured: baseline up to one year post intervention
Number of health care contacts
Measured: baseline up to one year post intervention
Experiences with your Health Care Provider (compare the mean scoring)
15 items measuring the caring relationship with a health care provider
Measured: baseline up to one year post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Skövde
- Responsible party
- Principal investigator, Anders Ringnér, Umeå University
- Investigators
- Anders Ringnér, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332226
- Sponsor's protocol ID
- PR2013-0086
- Acronym
- PIFBO
- Status last verified
- Nov 2021
- First submitted
- 11 Dec 2014
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25466827Ringner 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.
PubMed 36811905Ringner 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.
PubMed 36731493Ringner 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.
PubMed 26770070
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02332226
- Acronym / sponsor ID
- PIFBO / PR2013-0086
- Conditions
- Stress, Health Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- University of Skövde
- Study start
- Jan 2015
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Representational approach | Experimental | Behavioral: Representational approachFour 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. |
| Control | No intervention | –Standard care as per ward protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- None specific.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Representational approachRepresentational approach to patient education | Behavioural | Representational approach |
Primary outcome
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.
6 secondary outcomes
Impact of Event Scale-Revised (compare the mean scoring)
Time frame: 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
Anxiety and depression (compare the mean scoring)
Time frame: baseline up to one year post intervention
Satisfaction with information (compare the mean scoring)
Time frame: baseline up to one year post intervention
Number of health care contacts
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Background: PubMed 25466827Ringner 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.
- Derived from this study: PubMed 36811905Ringner 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.
- Derived from this study: PubMed 36731493Ringner 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.
- Derived from this study: PubMed 26770070Ringner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Ringnér, PhD principal investigator
Umeå University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Representational approach in people with Stress and Health Knowledge, Attitudes, Practice, run by Umeå University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Inventory for Parents (compare the mean scoring) (time frame: baseline up to one year post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02332226, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.