The HOLISTIC Study: Health-related Quality Of Life in Patients With Advanced Soft Tissue Sarcomas Treated With Chemotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Change in global health-related quality of life score after treatment with 1st line chemotherapy.
研究概览
简要总结
The benefits of cancer treatments, such as chemotherapy, are traditionally measured by outcomes such as progression free survival and overall survival. The degree to which treatments affect symptoms of disease, patient functioning and HRQoL are rarely measured or incorporated in the main endpoints of large-scale clinical trials. Systemic treatments for the majority of patients with advanced STS are not curative but aim to improve patients' HRQoL through reduction of symptoms, slowing or halting disease progression, and may extend life for some patients. Despite this, there is little research into the impact of chemotherapy on HRQoL for advanced STS patients. In order for patients to make an informed decision about chemotherapy and the predicted effects on all aspects of their lives, clinicians should be able to provide data on HRQoL. This will also enhance the shared decision-making process between clinicians and their patients. Given that survival benefits of treatment beyond 2nd line chemotherapy are marginal, and HRQoL data are lacking for patients treated with third line systemic treatment, simultaneous collection of HRQoL data in patients treated with 1st and 3rd line chemotherapy will enable assessment of the course of HRQoL in patients at the beginning, and further along, their treatment trajectory. After discontinuation of 1st or 3rd line chemotherapy, all patients will be followed up at 2-3 month intervals to determine trajectory of quality of life over time, irrespective of whether or not they receive subsequent line(s) of chemotherapy.
详细描述
Eligible patients with advanced soft tissue sarcoma will be introduced to this study by their hospital consultant during their routine outpatient appointment. Before deciding if he/she would like to take part, the patient will be provided with a patient information sheet which describes the study in detail. Participation in the study is entirely voluntary and their care will not be affected if he/she chooses not to take part.
The patient information sheet explains that this study involves completing regular questionnaires online, or by paper-and-pencil, about health-related quality of life, expectations of treatment, preferences for making treatment choices and thoughts at the end of chemotherapy.
If a patient agrees to take part, he/she will be asked to sign an informed consent form indicating their willingness to participate. Each patient will be given unique login details to complete the consent form online using the PROFILES website. If he/she prefers to receive paper versions of the questionnaires and complete a paper version of the informed consent form.
After informed consent has been given, each patient will be asked to complete the first questionnaire. This will take around 15-20 minutes to complete. Further questionnaires are completed every time the patient attends hospital for treatment with chemotherapy (each cycle). These questionnaires will take around 10-15 minutes to complete. Most patients have a maximum of six cycles of chemotherapy and therefore will complete six questionnaires during treatment. At the end of chemotherapy, patients will complete one further questionnaire. During follow-up patients will be asked to complete questionnaires online (or by paper) at home every 2-3 months. The maximum time a patient will participate in the study is 2 years.
Only after a participant has given consent, the research team will collect information for their medical files such as the date of their cancer diagnosis and any previous treatments received. This information will be linked to the questionnaire data at the end of the study, in order to analyse whether it is associated with health-related quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years
- •Diagnosis of advanced (not amenable to curative surgical resection) soft tissue sarcoma (histology confirmed by sarcoma histopathologist)
- •Starting 1st line palliative chemotherapy or 3rd line palliative chemotherapy according to standard treatment guidelines.
- •Able to communicate in English
- •Mental capacity to provide informed consent and to participate in the study (as determined by the treating physician).
- •Patients must be able to complete questionnaires themselves (a prerequisite for 'patient reported outcome' data).
- •Patients must be under treatment or follow-up at one of the participating centres
排除标准
- •Patients with GIST, Ewing sarcoma, rhabdomyosarcoma and desmoplastic small round cell tumour.
- •Patients who have already started 1st line or 3rd chemotherapy.
- •Patients who are too ill to receive any further systemic treatment (death is imminent), as determined by the referring health care professional
结局指标
主要结局
Change in global health-related quality of life score after treatment with 1st line chemotherapy.
时间窗: After up to six cycles of chemotherapy (approximately six months)
Patients will complete the EORTC-QLQ-C30 questionnaire at baseline and each cycle of chemotherapy. Question 30 asks patients to rate their global health-related quality of life on a scale from 1(very poor)- 7 (excellent). After linear transformation, patients will have a score from 0-100. A higher score on global health-related quality of life question means better HRQoL. Change in global HRQoL over treatment with first-line chemotherapy will be presented using descriptive statistics such as mean and standard deviation after each cycle. Change in global HRQoL will be tested using a paired sample t test from baseline to 4 cycles with a 2 sided 5 % significance level. For patients who do not complete 4 cycles, the last score/observation (post baseline) will be carried forward for the analysis. A sensitivity analysis will also be performed excluding those patients who do not reach 4 cycles. If data is not normally distributed, then the Wilcoxon test will be used.
次要结局
- Change in physical, cognitive, social, role and emotional functioning scores after treatment with first-line chemotherapy.(After up to six cycles of chemotherapy (approximately six months))
- Health-related quality of life symptoms scores after treatment with first line chemotherapy(After up to six cycles of chemotherapy (approximately six months))