Cultivating Resilience in Oncology Practice

Depressive Symptoms Clinical Trial

— CROP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04902313
• Other study ID #: 2020-01044
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 31, 2021
• Est. completion date: May 2, 2023

Study information

• Verified date: May 2021
• Source: Linkoeping University
• Contact: Oskar Lundgren, MD, Phd, MSc
• Phone: 70-2285546
• Email: oskar.lundgren[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Disorders and Symptoms
• Childhood Cancer
• Depression
• Depressive Symptoms
• Mental Health Issue

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Sweden	H.K.H. Crown Princess Victoria Children's Hospital, Linköping University Hospital, Sweden	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Strengths and Difficulties Questionnaire (SDQ)	25 items. Score (min-max): 0-25. A high score indicates psychiatric difficulties.	At the beginning of the trial.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.