Cultivating Resilience in Oncology Practice

Study Overview
=================
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.

Official Title
-----------------
Cultivating Resilience in Oncology Practice: A Feasibility Study of Pediatric Patients

Conditions
-----------------
Childhood Cancer, Depressive Symptoms, Anxiety Disorders and Symptoms, Mental Health Issue

Intervention / Treatment
-----------------
* Behavioral: Awareness and insight Modules (AiM)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional group of cancer patients, and observational group of pediatric patients with other chronic conditions.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cancer patients<br>Youths (10-18 y) with newly diagnosed cancer, as well as their family members. | Behavioral: Awareness and insight Modules (AiM)<br>* 12 week of daily reflection and meditation exercises, delivered by mobile phone text messages, after 3-4 live introduction sessions.<br>|
| Active Comparator: Pediatric patients<br>Youths (10-18 y) with a chronic somatic disease receiving care at a pediatric outpatient facility. | Behavioral: Awareness and insight Modules (AiM)<br>* 12 week of daily reflection and meditation exercises, delivered by mobile phone text messages, after 3-4 live introduction sessions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Health Continuum-Short Form (MHC-SF) | 14 items. Score (min-max): 0-70. A high score indicates mental well-being. | At the beginning of the trial. | 
| Mental Health Continuum-Short Form (MHC-SF) | 14 items. Score (min-max): 0-70. A high score indicates mental well-being. | After 12 weeks of participation in the trial. | 
| Mental Health Continuum-Short Form (MHC-SF) | 14 items. Score (min-max): 0-70. A high score indicates mental well-being. | At 12-month after completion of the trial. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strengths and Difficulties Questionnaire (SDQ) | 25 items. Score (min-max): 0-25. A high score indicates psychiatric difficulties. | At the beginning of the trial. | 
| Strenghs and Difficulties Questionnaire (SDQ) | 25 items. Score (min-max): 0-25. A high score indicates psychiatric difficulties. | After 12 weeks of participation in the trial. | 
| Strengths and Difficulties Questionnaire (SDQ) | 25 items. Score (min-max): 0-25. A high score indicate psychiatric difficulties. | At 12-month after completion of the trial. | 
| Revised Child Anxiety and Depression Scale Short form (RCADS-SF) | 25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression. | At the beginning of the trial. | 
| Revised Child Anxiety and Depression Scale (RCADS) | 25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression. | After 12 weeks of participation in the trial. | 
| Revised Child Anxiety and Depression Scale (RCADS) | 25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression. | At 12-month after completion of the trial. | 
| System Usability Scale (SUS) | 10 items. Score (min-max): 10-50. A high score indicates a high level of usability. | After completion of the 12 week trial. |