Anxiety Disorders and Symptoms, Childhood Cancer, Depressive Symptoms, Mental Health Issue
Conditions
Brief summary
The purpose of the CROP study is to investigate the potential to cultivate psychological resources and resilience in childhood cancer patients and their family members using a mobile phone-based intervention. 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.
Detailed description
The feasibility study (CROP) will recruit 20 youths with newly diagnosed cancer (10-18 y) and family members for participation in a 12-week digital intervention to cultivate psychological resources. 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.
Interventions
BEHAVIORALAwareness and insight Modules (AiM)
12 week of daily reflection and meditation exercises, delivered by mobile phone text messages, after 3-4 live introduction sessions.
Sponsors
Linkoeping University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Collection of data and analysis will be made by researcher with limited knowledge of participant status.
Intervention model description
Interventional group of cancer patients, and observational group of pediatric patients with other chronic conditions.
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed cancer * Chronic pediatric disease
Exclusion criteria
* Severe crisis reaction * Late-stage palliative care * Severe intellectual disability * Psychiatric disease hindrance * Participation in other study with psychological intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mental Health Continuum-Short Form (MHC-SF) | At the beginning of the trial. | 14 items. Score (min-max): 0-70. A high score indicates mental well-being. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Strengths and Difficulties Questionnaire (SDQ) | At the beginning of the trial. | 25 items. Score (min-max): 0-25. A high score indicates psychiatric difficulties. |
| Strenghs and Difficulties Questionnaire (SDQ) | After 12 weeks of participation in the trial. | 25 items. Score (min-max): 0-25. A high score indicates psychiatric difficulties. |
| Revised Child Anxiety and Depression Scale Short form (RCADS-SF) | At the beginning of the trial. | 25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression. |
| Revised Child Anxiety and Depression Scale (RCADS) | After 12 weeks of participation in the trial. | 25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression. |
| System Usability Scale (SUS) | After completion of the 12 week trial. | 10 items. Score (min-max): 10-50. A high score indicates a high level of usability. |
Countries
Sweden
Contacts
STUDY_CHAIRCatrin Furuhjelm, MD, PhD
Region Östergötland
Outcome results
None listed