Information to Parents of Children With Cancer. An Exploratory Study

NCT01502189 | Completed

• 1 other identifier: PROJ07/029
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress; Health Knowledge, Attitudes, Practice

Keywords

patient education as topic; representational approach; parents; childhood cancer; paediatric oncology; nursing; parents of children with cancer; Stress; Health Knowledge; Attitudes; Practice

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (5)

• Physical symptoms from stress

  Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).

• Anxiety

  Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).

• Depressive symptoms

  Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).

• Satisfaction with information

  Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).

• Healthcare contacts

  Changes during baseline and intervention period (measured once a week for a total of 11 weeks).

Study Arms (1)

Representational approach

EXPERIMENTAL

The Representational approach as described in the detailed description.

Other: Representational approach

Interventions

Representational approach OTHER

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.

Representational approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a parent of a child that
• is diagnosed with a first occurrence of a malignancy that is curatively treated
• 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.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Umeå University Hospital

Umeå, Västerbotten County, 90185, Sweden

Location

MeSH Terms

Conditions

Behavior; Neoplasms

Study Officials

• Ulla Hällgren Graneheim, Associate professor

  Umeå University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 30, 2011
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: August 1, 2013
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

SE (1)