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Information to Parents of Children With Cancer. An Exploratory Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01502189
Recruitment Status : Completed
First Posted : December 30, 2011
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Stress Health Knowledge, Attitudes, Practice Other: Representational approach

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Information to Parents of Children With Cancer. An Exploratory Study
Study Start Date : February 2012
Primary Completion Date : December 2012
Study Completion Date : August 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: Representational approach
The Representational approach as described in the detailed description.
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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502189


Locations
Sweden
Umeå University Hospital
Umeå, Västerbotten, Sweden, 90185
Sponsors and Collaborators
Umeå University
Investigators
Study Director: Ulla Hällgren Graneheim, Associate professor Umeå University
More Information

Responsible Party: Ulla Hallgren Graneheim, Associate professor, Umeå University
ClinicalTrials.gov Identifier: NCT01502189     History of Changes
Other Study ID Numbers: PROJ07/029
First Posted: December 30, 2011    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Ulla Hallgren Graneheim, Umeå University:
patient education as topic
representational approach
parents
childhood cancer
paediatric oncology
nursing
parents of children with cancer
Stress
Health Knowledge
Attitudes
Practice