NCT02332226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2014

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

4.5 years

First QC Date

December 11, 2014

Last Update Submit

November 13, 2021

Conditions

StressHealth Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline up to one year post intervention

Secondary Outcomes (6)

  • Impact of Event Scale-Revised (compare the mean scoring)

    baseline up to one year post intervention

  • Kowledge expectations of significant others and Received knowledge of significant others (compare the mean scorings)

    baseline up to one year post intervention

  • Anxiety and depression (compare the mean scoring)

    baseline up to one year post intervention

  • Satisfaction with information (compare the mean scoring)

    baseline up to one year post intervention

  • Number of health care contacts

    baseline up to one year post intervention

  • +1 more secondary outcomes

Study Arms (2)

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.

Behavioral: Representational approach

Control

NO INTERVENTION

Standard care as per ward protocol.

Interventions

Representational approachBEHAVIORAL

Representational approach to patient education

Representational approach

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None specific.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Skåne University Hospital

Lund, Sweden

Location

Umeå University Hospital

Umeå, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 25466827BACKGROUND

  • Ringner 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.

    PMID: 36811905DERIVED

  • Ringner 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.

    PMID: 36731493DERIVED

  • 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.

    PMID: 26770070DERIVED

MeSH Terms

Conditions

Behavior

Study Officials

  • Anders Ringnér, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Senior lecturer

Study Record Dates

First Submitted

December 11, 2014

First Posted

January 6, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2019

Study Completion

January 1, 2020

Last Updated

November 22, 2021

Record last verified: 2021-11

Locations

SE(2)