Improving Chemotherapy-induced Nausea Control Through Bright Ideas®-CIN Training: a Feasibility Study in Children Receiving Oral Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 8
- 主要终点
- Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months
研究概览
简要总结
In this study investigators will determine the feasibility of a future trial comparing chemotherapy-induced nausea control in children with ALL receiving oral 6-mercaptopurine who do and do not receive problem-solving skill training. This is a novel approach to controlling an important and common treatment-related symptom.
详细描述
This study will evaluate a novel approach to controlling a treatment-related symptom that detracts significantly from the quality of life of many patients. It will preserve and enhance the patient's and family's autonomy with respect to self-care. If found to be effective, this approach may be generalizable to pediatric patients receiving chemotherapy other than 6-mercaptopurine and thus has the potential to improve the quality of life of many children receiving cancer therapy.
This study will evaluate the efficacy of Bright IDEAS-CIN, adapted from the validated Bright IDEAS framework to improve CIN control in children with ALL who experience nausea while receiving 6-mercaptopurine. Bright IDEAS is an 8-session face-to-face intervention with a caregiver. In this first session, the caregiver is taught the problem-solving framework and begins working on their first self-selected problem. Sessions 2-7 involve working through relevant problems, with most caregivers working through 3-4 different problems. The final session summarizes the skills and discusses how to continue to use these new skills for new problems instead of lapsing into old ineffective strategies. Investigators adapted Bright IDEAS to meet the specific problem of CINV by adapting it to 3 sessions focused specifically on CINV, including the child in the conversation when developmentally appropriate and allowing the latter sessions to be conducted by phone or video-chat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 4 years (PeNAT validated in patients 4 to 18 yrs)
- •newly diagnosed or recurrent disease: first diagnosis of ALL (i.e. non-relapsed) in maintenance therapy
- •English, French or Spanish-speaking with an English, French or Spanish-speaking guardian (PeNAT available in these languages)
- •without physical or cognitive impairments that preclude use of the PeNAT
- •planned to receive PO 6-mercaptopurine
- •not planned to receive IV, IM, SC or IT chemotherapy or oral or IV corticosteroids during the 7-day study period
排除标准
- 未提供
结局指标
主要结局
Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months
时间窗: 24 months from study activation
A future trial will be feasible if * 50% of patients deemed to be eligible to participate in Phase 1 consent/assent to participate * the recruitment into Phase 2 of 20 evaluable patients across all participating centers within 24 months of study activation of whom 80% return a completed CINV diary for at least 5 days of each 7-day data collection period. A completed CINV diary contains at least one PeNAT score and a record of the time of each vomiting episode or noting the presence/absence of vomiting daily. Evaluable patients are defined as those who have completed at least one cycle of PSST.
次要结局
- CIN and CIV incidence(24 months from study activation)
研究者
Lee Dupuis
Senior Associate Scientist
The Hospital for Sick Children