- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01502189
Information to Parents of Children With Cancer. An Exploratory Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Västerbotten
-
Umeå, Västerbotten, Sweden, 90185
- Umeå University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Representational approach
The Representational approach as described in the detailed description.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).
|
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.
|
Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).
|
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.
|
Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).
|
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.
|
Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).
|
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.
|
Changes during baseline and intervention period (measured once a week for a total of 11 weeks).
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ulla Hällgren Graneheim, Associate professor, Umea University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PROJ07/029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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