A Randomized Controlled Trial Comparing Active Intervention at Diagnosis With Usual Care to Improve the Psycho-social Care in the Adolescent and Young Adult Oncology (AYAO) Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Extent of symptom burden measured using Rotterdam Symptom Checklist (RSCL)
研究概览
简要总结
Adolescents and young adults (AYA) patients experience significant distress in specific areas at diagnosis. The investigators hypothesize that providing developmentally-appropriate AYA-specific psychosocial care, with an individualized multi-disciplinary program will alleviate this distress, as well as improve health-related quality of life (HRQOL).
The investigators' primary aim is to evaluate the impact of psychosocial interventions on HRQOL. The secondary aims are to firstly identify the types of psychosocial distress experienced and secondly, to assess the feasibility of implementing a psychosocial screening and intervention program amongst AYA patients newly diagnosed with cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 to 39 years old
- •Newly diagnosed with any form of cancers
- •Capable of giving informed consent (by patients or parents, whichever applicable)
- •Ability to understand and willingness to sign a written informed consent document
- •Able to speak and understand English
- •Able to commit to attending the 3 info-educational sessions as well as patient-directed additional visits
排除标准
- •Patients with uncontrolled brain metastasis.
- •Patients who are unable to commit to attend all 3 info-educational sessions
- •Patients who are unable to communicate in English.
结局指标
主要结局
Extent of symptom burden measured using Rotterdam Symptom Checklist (RSCL)
时间窗: 6 months post recruitment
The Rotterdam Symptom Checklist (RSCL) is a self-report measure to assess the quality of life of cancer patients. It uses a 4-point Likert-type scales (not at all, a little, quite a bit, very much) to measure four domains, namely the physical symptom distress (23 items), psychological distress (7 items) activity level (8 items) overall valuation of life (1 item). The higher the score, the higher the level of burden or impairment. Standardized scores of scales can also be obtained when comparing different scales by transforming raw scores into scores on a 100-point scale using the formula \[(raw scale score - minimum raw score) / (maximum - minimum score)\] x 100 = transformed score.
Health-related quality of life using PedsQL 4.0 Generic Core Scales
时间窗: 6 months post recruitment
Pediatrics Quality of Life Inventory (PedsQL) is a model used to measure health-related quality of life (HRQOL) in adolescents and young adults by generating a physical health summary score and psychosocial health summary score both ranging from 0-100, whereby a higher score suggests a better HRQOL. It encompasses physical, mental, and social health, the core dimensions of health defined by the World Health Organization, as well as is school functioning to generate pediatric HRQOL.
次要结局
- Satisfaction Questionnaire(At 3 months from baseline)
- Patients' distress levels using the National Comprehensive Cancer Network (NCCN) Distress Thermometer(6 months post recruitment)