Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-05-31
2023-05-02
Brief Summary
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The feasibility study aims to evaluate the implementation and participant experience of the digital intervention and register psychological outcome measures preliminary evidence for its acceptability, feasibility, and potential beneficial effects.
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Detailed Description
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Investigators will recruit an equal number of pediatric patients with other chronic conditions to an observational comparison group to indicate the influences on participation and outcome from the oncology care context.
Investigators will obtain informed consent from all participants. Upon inclusion in the study, participants will start getting a text message every day for 12 consecutive weeks. The texts will contain links to a digital platform on which participants will complete an exercise in either self-reflection or guided mindfulness meditation.
The psychological training program is based on 12 modules with evidence-based treatments in other medical contexts and age groups. The practices are based on acceptance, commitment, re-appraisal, meaning and purpose, expressive writing, narrative processes, mindfulness, compassion, equanimity, and gratitude. The combination of practices and the implementation in pediatric oncology has not been studied earlier.
The cancer patients will be recruited during the first month after diagnosis, meet with an instructor during 2-4 start-up meetings, and thereafter practice on their own or with participating family members.
The pediatric patients with chronic diseases will be recruited during a follow-up visit to an out-patient clinic and meet with an instructor during 2-4 start-up meetings, and thereafter practice on their own or together with participating family members.
Investigators will address the primary research question of the feasibility of the intervention by investigating participant activity data, written evaluations of the experience of participation, and through phone interviews of participants.
Secondary research questions, such as preliminary data on changes in mental health and psychological distress, will be investigated with self-report questionnaires.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Cancer patients
Youths (10-18 y) with newly diagnosed cancer, as well as their family members.
Awareness and insight Modules (AiM)
12 week of daily reflection and meditation exercises, delivered by mobile phone text messages, after 3-4 live introduction sessions.
Pediatric patients
Youths (10-18 y) with a chronic somatic disease receiving care at a pediatric outpatient facility.
Awareness and insight Modules (AiM)
12 week of daily reflection and meditation exercises, delivered by mobile phone text messages, after 3-4 live introduction sessions.
Interventions
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Awareness and insight Modules (AiM)
12 week of daily reflection and meditation exercises, delivered by mobile phone text messages, after 3-4 live introduction sessions.
Eligibility Criteria
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Inclusion Criteria
* Chronic pediatric disease
Exclusion Criteria
* Late-stage palliative care
* Severe intellectual disability
* Psychiatric disease hindrance
* Participation in other study with psychological intervention
10 Years
18 Years
ALL
No
Sponsors
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Linkoeping University
OTHER_GOV
Responsible Party
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Oskar Lundgren
Lecturer
Principal Investigators
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Catrin Furuhjelm, MD, PhD
Role: STUDY_CHAIR
Region Östergötland
Locations
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H.K.H. Crown Princess Victoria Children's Hospital, Linköping University Hospital, Sweden
Linköping, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-01044
Identifier Type: -
Identifier Source: org_study_id
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