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Completed

NCT Number: NCT01502189

Information to Parents of Children With Cancer. An Exploratory Study

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.

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Key information

Conditions

Stress Behavior Health Knowledge, Attitudes, Practice Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umeå University Hospital

Umeå, Västerbotten County, 90185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Perceived stress

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

    As measured by the Perceived stress scale (PSS). 10 items answered on a 5-point Likert scale.

Secondary outcomes

  1. Physical symptoms from stress

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

    Includes headache, sleep disturbances, palpitations, and heartburn, each measured on a 4-point scale.

  2. Anxiety

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

    Measured on a 7-point visual digital scale.

  3. Depressive symptoms

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

    Measured on a 7-point visual digital scale.

  4. Satisfaction with information

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

    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.

  5. Healthcare contacts

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

    Number of contacts with the health care system concerning the ill child and the parent's own health problems.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Dec 30, 2011
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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