Information to Parents of Children With Cancer. An Exploratory Study

Stress Clinical Trial

Official title:

Information to Parents of Children With Cancer. An Exploratory Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502189
• Other study ID #: PROJ07/029
• Status: Completed
• Phase: N/A
• First received: December 21, 2011
• Last updated: December 1, 2014
• Start date: February 2012
• Est. completion date: August 2013

Study information

• Verified date: December 2014
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to explore whether an intensified informational intervention built upon the Representational approach framework can reduce stress in parents of children with cancer.

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.

HYPOTHESIS

An informational intervention emanating from the needs identified by parents is associated to decreased perceived stress, decreased depressive symptoms, decreased anxiety, increased satisfaction with information and decreased use of health care contacts in parents.

INTERVENTION

The intervention builds upon the Representational approach. This approach emanates from Leventhal's theories of illness representations and theories of conceptual change. Central qualities in the approach is that parents identify the area where information is needed themselves and that a thorough assessment of their current representation of that area is performed before information is given.

Each participating parent receives three rounds that consist of two meetings. Each round starts with a meeting where the parent identifies an area where he/she needs more information. The nurse and the parent jointly survey the parent's representation of the area and discusses consequences of knowledge gaps or misunderstandings. Then, new information is introduced and benefits from the new information is discussed. After some days, a follow-up meeting takes place.

DESIGN AND METHODS

The intervention will be evaluated using a single-case design (A-B-A-B-A-B-A) with 10 parents. All parents will receive the intervention, and repeated measures of the outcome variables both before and after will be used to assess the effect of the intervention. Data will be collected by web questionnaires with SMS- and e-mail reminders.

In parallel, a process evaluation aiming at describing treatment fidelity, experiences of participation and impact of contextual factors on the results. For this aim, qualitative interviews with participants and audio recording of intervention sessions will be used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being a parent of a child that

1. is diagnosed with a first occurrence of a malignancy that is curatively treated

2. was diagnosed two months ago

• Able to talk, read and write Swedish enough to be able to participate without an interpreter

• Have access to a computer and an internet connection.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Health Knowledge, Attitudes, Practice
• Stress

Intervention

Other:
• Representational approach
The Representational approach as described in the detailed description. Each participating parent receives three rounds that consist of two meetings. Each round starts with a meeting where the parent identifies an area where he/she needs more information. The nurse and the parent jointly survey the parent's representation of the area and discusses consequences of knowledge gaps or misunderstandings. Then, new information is introduced and benefits from the new information is discussed. After some days, a follow-up meeting takes place.

Locations

Country	Name	City	State
Sweden	Umeå University Hospital	Umeå	Västerbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived stress	As measured by the Perceived stress scale (PSS). 10 items answered on a 5-point Likert scale.	Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).	No
Secondary	Physical symptoms from stress	Includes headache, sleep disturbances, palpitations, and heartburn, each measured on a 4-point scale.	Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).	No
Secondary	Anxiety	Measured on a 7-point visual digital scale.	Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).	No
Secondary	Depressive symptoms	Measured on a 7-point visual digital scale.	Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).	No
Secondary	Satisfaction with information	Includes general satisfaction with the information from the health care professionals as well as information from the intervention nurses. Measured on a 7-point visual digital scale.	Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).	No
Secondary	Healthcare contacts	Number of contacts with the health care system concerning the ill child and the parent's own health problems.	Changes during baseline and intervention period (measured once a week for a total of 11 weeks).	No