Information to Parents of Children With Cancer. An Exploratory Study
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ClinicalTrials.gov Identifier: NCT01502189 |
Recruitment Status
:
Completed
First Posted
: December 30, 2011
Last Update Posted
: December 3, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stress Health Knowledge, Attitudes, Practice | Other: Representational approach | Not Applicable |
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 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 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | August 2013 |
Arm | Intervention/treatment |
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Experimental: Representational approach
The Representational approach as described in the detailed description.
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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.
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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

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
Sweden | |
Umeå University Hospital | |
Umeå, Västerbotten, Sweden, 90185 |
Study Director: | Ulla Hällgren Graneheim, Associate professor | Umeå University |
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 |