A Mobile Supportive Care App for Patients With Metastatic Lung Cancer: a Pilot Randomized Controlled Trial - The Lung Cancer App (LuCApp) Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 主要终点
- The primary outcome is the change in the score of the Trial Outcome Index (TOI) in the Functional Assessment of Cancer Therapy (Lung) questionnaire from baseline to 12 weeks.
研究概览
简要总结
Self-management interventions can help patients and their families care for themselves along the cancer care continuum. This scenario has witnessed the rapid and ongoing growth in mobile technologies, including mobile health (mHealth). LuCApp (Lung Cancer App) is an application developed by researchers and lung cancer clinicians to gather symptom data in real time and to share it with healthcare professionals. This is a 24-week, two-arm, non-blinded multicenter feasibility parallel randomized controlled trial aimed to evaluate the usability and effectiveness of LuCApp vs standard care to improve self-management of symptoms and health related quality of life in lung cancer patients.
详细描述
Background: Self-management interventions can help patients and their families care for themselves along the cancer care continuum. This scenario has witnessed the rapid and ongoing growth in mobile technologies, including mobile health (mHealth). LuCApp (Lung Cancer App) is an application developed by researchers and lung cancer clinicians to gather symptom data in real time and to share it with healthcare professionals.
Objectives: To evaluate the usability and effectiveness of LuCApp vs standard care to improve self-management of symptoms and health related quality of life in lung cancer patients.
Design: This is a 24-week, two-arm, non-blinded multicenter feasibility parallel randomized controlled trial.
Patient population: Adults of both sexes diagnosed with small or non-small cell lung cancer, eligible for pharmaceutical treatments with good performance status and life expectancy of ≥6 months or more, fluently speaking Italian and able to use a smartphone will be eligible for recruitment. Participants will remain on study until discontinuation of cancer treatment, voluntary withdrawal, study termination or death.
Intervention and comparator: Consenting patients will be assigned in a 1:1 randomized way to receiving either standard care or LuCApp in addition to standard care. During the treatment period, LuCApp allows daily monitoring and grading of a list of symptoms which trigger alerts to the physicians in case predefined severity thresholds are met.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18 years of age individuals of both sexes;
- •diagnosed with small or non-small cell lung cancer;
- •patients eligible for chemotherapy, immunotherapy or biological therapy;
- •patients diagnosed with non-resectable tumor and eligible for neoadjuvant therapies;
- •life expectancy of six months or more;
- •a performance status between 0 (asymptomatic) and 2 (symptomatic, <50% in bed during the day) according to the Eastern Cooperative Oncology Group (ECOG) score;
- •patients fluently speaking Italian;
- •patients able to provide informed consent to participate in the study;
- •patients who own a smartphone that can access either the iOS or the Android platform.
排除标准
- •individuals unable to provide written informed consent;
- •individuals unable to see the App and all other materials (i.e. are blind);
- •patients receiving or that plan to receive radiotherapy or surgical resection;
- •patients already included or about to join other clinical trials;
- •patients already using other smartphone applications to self-manage cancer symptoms.
研究组 & 干预措施
LuCApp + Standard Care
LuCApp (Lung Cancer App) is an application developed by researchers and lung cancer clinicians to gather symptom data in real time and to share it with healthcare professionals.
LuCApp allows daily monitoring and grading of a list of symptoms which trigger alerts to the physicians in case predefined severity thresholds are met.
干预措施: The Lung Cancer App - LuCApp (Other)
Standard Care
Usual care will consist of standard procedures currently available at participating centers for monitoring and documenting symptoms. These therapeutical procedures are based on the guidelines developed by the National Comprehensive Cancer Network (NCCN) and the Associazione Italiana di Oncologia Medica (AIOM). Symptoms for control arm patients will be discussed and registered during scheduled clinical visits with the oncologists. Standard-of-care patients will fill out their PROMs following the same schedule identified for LuCApp patients with paper questionnaires during clinic visits, or at home (having received paper questionnaires during the previous visit) or via telephonic interviews with the research team.
干预措施: Standard care (Other)
结局指标
主要结局
The primary outcome is the change in the score of the Trial Outcome Index (TOI) in the Functional Assessment of Cancer Therapy (Lung) questionnaire from baseline to 12 weeks.
时间窗: 12 weeks
FACT-L questionnaire contains four general and one lung cancer symptom-specific subscales. General subscales include: Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). The Lung Cancer Subscale (LCS) assesses symptoms commonly reported by lung cancer patients (e.g., shortness of breath; loss of weight; tightness in chest). The TOI is derived by adding scores on the PWB and FWB subscales to the LCS. Because they contain the most relevant questions about symptoms and physical functioning, the LCS and TOI were selected as the primary focus of this analysis.
次要结局
- ZBI(24 weeks)
- SCNS-SF34(24 weeks)
- Usability of LuCApp(24 weeks)
- Resource use(0-24 weeks)
- HADS(The questionnaire will be administered at baseline, at 12 weeks, and at 24 weeks.)
- Satisfaction of LuCApp(24 weeks)
- Eq-5D-5L(The questionnaire will be administered at baseline, every 3 ± 1 weeks up to 24 weeks from date of randomization)