Expectations and Priorities of Elderly Patients for a First Medical Treatment for Cancer : PRIORITY Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation
研究概览
简要总结
The main objective of study is to describe the priorities of elderly patients (70 years and over) undergoing a first medical treatment for cancer, at initiation of treatment and after 3 months of treatment. The main criterion is a prioritization of 4 items per patient from a list of 8 expectations regarding the objectives of their treatment: treatment efficacy, life expectancy, autonomy, daily activities, social activities, heaviness of treatment, toxicity, economics.
详细描述
For the primary endpoint assessment, this self-administered patient questionnaire will used an opinion scale (Not at all, A little, Moderately, Enough, Many) to explore the eight domains. Next to the completion of the expectations questionnaire, patients will have to order 4 of the different 8 items that they prioritized in regard of the first line treatment that has just been prescribed by their physician.
Secondary endpoint will focus on those 8 proposed expectations of patients at different periods of time since treatment initiation. Patients' priorities will be compared to physician's priorities (using the same prioritization grid) before medical treatment and after 3 months of treatment and to younger patients' priorities (18-69 years). Associations between elderly patients' characteristics (social, medical...) and their priorities will be search.
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
- •Male or female:
- •Age ≥ 70 years
- •Aged 18-69 years (case population)
- •ECOG / performance status 0-3 (WHO).
- •First line of medical oncology treatment (chemotherapy, targeted therapy, hormone therapy, combination):
- •Neo-adjuvant setting,
- •Adjuvant setting: previous neo-adjuvant treatment is allowed,
- •Metastatic setting: previous neo-adjuvant and/or adjuvant treatment are allowed,
- •Solid tumors (breast, colorectal, kidney, lung, prostate, sarcoma, and ovarian) and lymphoma (indolent and aggressive).
- •Life expectancy of more than 3 months.
- •Patients potentially compliant with the rules of the follow-up study.
- •Patients affiliated to a social security scheme.
- •Patients who received clear information from the investigator on the study and had not refused to participate.
排除标准
- •Exclusive surgery treatment.
- •Exclusive radiotherapy treatment or in combination with oncological medical treatment (concomitant radio-chemotherapy or radio-hormonotherapy).
- •Previous first line of oncological medical treatment in the same indication as the one concerned by the inclusion:
- •Neo-adjuvant setting: previous line(s) of neo-adjuvant medical treatment,
- •Adjuvant setting: previous line(s) of adjuvant medical treatment,
- •Metastatic setting: previous line(s) of metastatic medical treatment,
- •Supportive care without specific medical treatment
- •Previous or ongoing cancer under treatment at the time of inclusion.
- •Patient already included in this study
- •Patient who for psychological, psychiatric, social, family or geographical reasons could not be regularly monitored according to the criteria of the study; patient private of liberty or under guardianship.
结局指标
主要结局
Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation
时间窗: Day 0 initiation of treatment
Prioritization among of the 4 items selected from a list of 8 expectations regarding the objectives of their treatment : treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden. For each expectation, the number and rate of priorization are reported.
Priorities of Patients Receiving First Medical Treatment for Cancer 3 Months After Initiation of Treatment
时间窗: 3 months after initiation of treatment
Prioritization among of the 4 items selected from a list of 8 expectations regarding the objectives of their treatment : treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden. For each expectation, the number and rate of priorization are reported.
次要结局
- Expectations of Patients at Initiation of Treatment(Day 0 initiation of treatment)
- Expectations of Patients 3 Months After Initiation of Treatment(3 months after initiation of treatment)
- Stability of Patients in Their Priorities at 3 Months(3 months after initiation of treatment)
- 1-year Overall Survival(From inclusion to the end of study)
- Agreement Rate for Prioritization of Expectations Between Patients and Physicians(Day 0 initiation of treatment)