How Are You Getting on? Nurse-led Proactive Telephone Follow-up With Patients After Completion of Primary Cancer Treatment Increases Their Sense of Security and Well-being
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 512
- 试验地点
- 2
- 主要终点
- Patients' reported Quality of life
研究概览
简要总结
The goal of this randomized study is to test and evaluate nurse-led telephone follow-up intervention in patients primarily curatively treated for breast cancer, colorectal cancer, and prostate cancer.
The main question aims to answer:
Does this nurse-led telephone follow-up improve patients' quality of life? Participants in both groups will be asked to fill in questionnaires regularly. The intervention group will get a telephone follow-up at predetermined intervals, while the control group will get the care as usual.The investigators will compare intervention and control groups to see if predetermined regular nurse-led telephone follow-up improves quality of life.
详细描述
The hypothesis is that nurse-led telephone follow-up will improve the quality of life in patients primarily curatively treated for breast cancer, colorectal cancer, and prostate cancer.
Participants in both groups will respond to a survey regularly during one year from inclusion. The intervention group will get a telephone follow-up at predetermined intervals (1, 3, 6, 9, 12 months) while the control group will get the care as usual. The usual care means that no proactive support is offered to patients from health care while they wait for follow-up, but patients are of course allowed to contact health care if they needed.
Participants in both groups are asked to respond on a survey concerning their quality of life, feelings of anxiety and depression, perception of illness, and experienced symptoms and discomfort regarding to cancer. Additionally, the number of visits at the health care during the waiting for follow-up will be collected from both group.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being primarily curatively treated for breast, colorectal-, or prostate cancer
排除标准
- •no adjuvant treatment
- •no cognitive impairment
- •no known alcohol or other misuse
结局指标
主要结局
Patients' reported Quality of life
时间窗: Baseline, 3 months, 6 months and 12 months from inclusion
Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) The questionnaire consists of 30 items. The QLQ-C30 is composed of both multi-item scales and single-items measures and includes five functional scales, three symptom scales, a global health status /QoL(quality of life) scale, and six single items. Twenty-eight items are answered on a four-point Likert scale with response option labeled "Nor at all", "A little", "Quite a bit" and "Very Much". The last two questions have a seven point scale, ranging from 1 ("Very Poor") to seven ("Excellent"). Higher score for a functional scale represents a high/healthy level of functioning, a high score for the global health status represents a high QoL but a high score for a symptom scale/item represents a high level of symptomatology/problems. The minimum in values is 0, and maximum in values is 100.
次要结局
- Patients' reported quality(Baseline, 3 months, 6 months and 12 months from inclusion)
- Patients' reported anxiety and depression(Baseline, 3 months, 6 months and 12 months from inclusion)
- Patients' experiences of prostata cancer related to symptoms and side effects of treatment and diagnosis.(Baseline, 3 months, 6 months and 12 months from inclusion)
- Patients' perceptions of illness(Baseline, 3 months, 6 months and 12 months from inclusion)
- Patients' experiences of breast cancer related to body image, sexual functioning, systemic therapy side effects and symptoms(Baseline, 3 months, 6 months and 12 months from inclusion)
- Patients' experiences of colorectal cancer related to symptoms and side effects of treatment and diagnosis.(Baseline, 3 months, 6 months and 12 months from inclusion)