Clinical trial NCT01502189: Information to Parents of Children With Cancer. An Exploratory Study
Official title: Information to Parents of Children With Cancer. An Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2011-12-30
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perceived stress
timeFrame: Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).
Secondary outcomes:
measure: Physical symptoms from stress
timeFrame: Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).
measure: Anxiety
timeFrame: Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).
measure: Depressive symptoms
timeFrame: Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).
measure: Satisfaction with information
timeFrame: Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).
measure: Healthcare contacts
timeFrame: Changes during baseline and intervention period (measured once a week for a total of 11 weeks).
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University Hospital
state: Västerbotten
Study officials:
affiliation: Umeå University
name: Ulla Hällgren Graneheim, Associate professor
role: STUDY_DIRECTOR
References: