StressNCT01502189
Information to Parents of Children With Cancer. An Exploratory Study
A study testing Representational approach in people with Stress and Health Knowledge, Attitudes, Practice, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Health Knowledge, Attitudes, Practice
- What is being tested?
- Representational approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Stress, Health Knowledge, Attitudes, Practice
- Being tested
- Representational approach
- Keywords
- patient education as topic, representational approach, parents, childhood cancer, paediatric oncology, nursing, parents of children with cancer, Stress, Health Knowledge, Attitudes, Practice
- Medical subject headings
- Behavior, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Representational approachOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Representational approach | Experimental | The Representational approach as described in the detailed description. Receives: Other: Representational approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress
As measured by the Perceived stress scale (PSS). 10 items answered on a 5-point Likert scale.
Measured: Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).
Secondary outcomes (5)
Physical symptoms from stress
Includes headache, sleep disturbances, palpitations, and heartburn, each measured on a 4-point scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Changes during baseline and intervention period (measured once a week for a total of 11 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulla Hallgren Graneheim, Umeå University
- Investigators
- Ulla Hällgren Graneheim, Associate professor, Study director, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502189
- Sponsor's protocol ID
- PROJ07/029
- Status last verified
- Dec 2014
- First submitted
- 21 Dec 2011
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Information to Parents of Children With Cancer. An Exploratory Study
- ClinicalTrials.gov ID
- NCT01502189
- Acronym / sponsor ID
- PROJ07/029
- Conditions
- Stress, Health Knowledge, Attitudes, Practice
- Keywords
- patient education as topic, representational approach, parents, childhood cancer, paediatric oncology, nursing, parents of children with cancer, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 30 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Representational approach | Experimental | Other: Representational approachThe Representational approach as described in the detailed description. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being a parent of a child that
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Representational approachThe 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. | Other | Representational approach |
Primary outcome
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.
5 secondary outcomes
Physical symptoms from stress
Time frame: 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).
Depressive symptoms
Time frame: 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).
Healthcare contacts
Time frame: Changes during baseline and intervention period (measured once a week for a total of 11 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulla Hällgren Graneheim, Associate professor study director
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Representational approach in people with Stress and Health Knowledge, Attitudes, Practice, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived stress (time frame: Changes during baseline and intervention period (measured twice a week for a total of 11 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.