- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04902313
Cultivating Resilience in Oncology Practice (CROP)
Cultivating Resilience in Oncology Practice: A Feasibility Study of Pediatric Patients
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Oskar Lundgren, MD, Phd, MSc
- Phone Number: 46 70-2285546
- Email: oskar.lundgren@liu.se
Study Locations
-
-
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Linköping, Sweden, 58183
- H.K.H. Crown Princess Victoria Children's Hospital, Linköping University Hospital, Sweden
-
Contact:
- Oskar Lundgren, MD, PhD, MSc
- Phone Number: 46 010-1030326
- Email: oskar.lundgren@regionostergotland.se
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cancer patients
Youths (10-18 y) with newly diagnosed cancer, as well as their family members.
|
12 week of daily reflection and meditation exercises, delivered by mobile phone text messages, after 3-4 live introduction sessions.
|
Active Comparator: Pediatric patients
Youths (10-18 y) with a chronic somatic disease receiving care at a pediatric outpatient facility.
|
12 week of daily reflection and meditation exercises, delivered by mobile phone text messages, after 3-4 live introduction sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental Health Continuum-Short Form (MHC-SF)
Time Frame: At the beginning of the trial.
|
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)
Time Frame: After 12 weeks of participation in the trial.
|
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)
Time Frame: At 12-month after completion of the trial.
|
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)
Time Frame: At the beginning of the trial.
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25 items.
Score (min-max): 0-25.
A high score indicates psychiatric difficulties.
|
At the beginning of the trial.
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Strenghs and Difficulties Questionnaire (SDQ)
Time Frame: After 12 weeks of participation in the trial.
|
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)
Time Frame: At 12-month after completion of the trial.
|
25 items.
Score (min-max): 0-25.
A high score indicate psychiatric difficulties.
|
At 12-month after completion of the trial.
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Revised Child Anxiety and Depression Scale Short form (RCADS-SF)
Time Frame: At the beginning of the trial.
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25 items.
Score (min-max): 0-75.
A high score indicates symptoms of anxiety and depression.
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At the beginning of the trial.
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Revised Child Anxiety and Depression Scale (RCADS)
Time Frame: After 12 weeks of participation in the trial.
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25 items.
Score (min-max): 0-75.
A high score indicates symptoms of anxiety and depression.
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After 12 weeks of participation in the trial.
|
Revised Child Anxiety and Depression Scale (RCADS)
Time Frame: At 12-month after completion of the trial.
|
25 items.
Score (min-max): 0-75.
A high score indicates symptoms of anxiety and depression.
|
At 12-month after completion of the trial.
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System Usability Scale (SUS)
Time Frame: After completion of the 12 week trial.
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10 items.
Score (min-max): 10-50.
A high score indicates a high level of usability.
|
After completion of the 12 week trial.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Catrin Furuhjelm, MD, PhD, Region Östergötland
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-01044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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