Cultivating Resilience in Oncology Practice: A Feasibility Study of Pediatric Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mental Health Continuum-Short Form (MHC-SF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Collection of data and analysis will be made by researcher with limited knowledge of participant status.
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed cancer
- •Chronic pediatric disease
排除标准
- •Severe crisis reaction
- •Late-stage palliative care
- •Severe intellectual disability
- •Psychiatric disease hindrance
- •Participation in other study with psychological intervention
研究组 & 干预措施
Cancer patients
Youths (10-18 y) with newly diagnosed cancer, as well as their family members.
干预措施: Awareness and insight Modules (AiM) (Behavioral)
Pediatric patients
Youths (10-18 y) with a chronic somatic disease receiving care at a pediatric outpatient facility.
干预措施: Awareness and insight Modules (AiM) (Behavioral)
结局指标
主要结局
Mental Health Continuum-Short Form (MHC-SF)
时间窗: At 12-month after completion of the trial.
14 items. Score (min-max): 0-70. A high score indicates mental well-being.
Mental Health Continuum-Short Form (MHC-SF)
时间窗: At the beginning of the trial.
14 items. Score (min-max): 0-70. A high score indicates mental well-being.
Mental Health Continuum-Short Form (MHC-SF)
时间窗: After 12 weeks of participation in the trial.
14 items. Score (min-max): 0-70. A high score indicates mental well-being.
次要结局
- Revised Child Anxiety and Depression Scale Short form (RCADS-SF)(At the beginning of the trial.)
- Strengths and Difficulties Questionnaire (SDQ)(At 12-month after completion of the trial.)
- Revised Child Anxiety and Depression Scale (RCADS)(At 12-month after completion of the trial.)
- System Usability Scale (SUS)(After completion of the 12 week trial.)
- Strenghs and Difficulties Questionnaire (SDQ)(After 12 weeks of participation in the trial.)
- Strengths and Difficulties Questionnaire (SDQ)(At the beginning of the trial.)
- Revised Child Anxiety and Depression Scale (RCADS)(After 12 weeks of participation in the trial.)
研究者
Oskar Lundgren, MD, PhD, MSc
Lecturer
Linkoeping University