Information to Parents of Children With Cancer. An Exploratory Study

Study Overview
=================
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.

Official Title
-----------------
Information to Parents of Children With Cancer. An Exploratory Study

Conditions
-----------------
Stress, Health Knowledge, Attitudes, Practice

Intervention / Treatment
-----------------
* Other: Representational approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Representational approach<br>The Representational approach as described in the detailed description. | Other: Representational approach<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient education as topic, representational approach, parents, childhood cancer, paediatric oncology, nursing, parents of children with cancer, Stress, Health Knowledge, Attitudes, Practice