To Live Better and Longer With Prostate Cancer: Effects of Supportive and Person-centered Care Assisted by Mobile Technology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Acceptability E -scale
研究概览
简要总结
It is evident that patients receiving treatment for cancer have symptoms that often are undetected. Furthermore, many survivors from cancer have ongoing poor health and well-being and long-term rehabilitation and support should not be neglected to prevent recurrence and increase survival. There are good reasons to believe that routine collection of relevant patient-reported symptoms facilitates a person-centered care where the patient is a participatory member in the team. This study aims to evaluate the effects of routine assessment of diagnose-related symptoms assisted with an app during the first year of survivor ship in patients with prostate cancer in combination with survivor ship care coached by a district nurse, in primary health care and compare it to standard care only. The hypothesis is improved symptom burden and improved quality of life.
详细描述
Prostate cancer is the most common form of cancer in Sweden and the most common form of cancer among men in Sweden, representing approximately 30 percent of all cancer cases among men. The median age for being diagnosed with prostate cancer is around 69. The treatments available for prostate cancer can impact the patients' quality of life (QoL) (Katz, 2007). After surgery and radiation treatment, the function of the bowel and bladder is affected. Erectile dysfunction is common after surgery, radiation, and hormonal therapy. Symptoms and side effects can start quite suddenly, get improved, but also persist a long time after treatment.
Psychosocial support to patients during the treatment shows different results, some with positive effects on QoL by psychoeducational or nurse-delivered interventions and some with no effect at all.
Patient-reported outcome (PRO) is an outcome that is reported by the patients. Previous research on collecting PROs through an interactive application during treatment for breast cancer, pancreatic cancer, and prostate cancer shows promising results such as reduced symptom burden and improved QoL as well as on survival. A synthesis of current research on web-based interventions shows how important it is that content is specific to the patients' needs and delivered at the right stage in the cancer trajectory and emphasize user involvement in the developmental phase.
The aim is to evaluate the effects of routine assessment of patient reported symptoms and support in self-management assisted with mobile technology (an app) during the first year of survivorship in patients with breast- and prostate cancer in combination with survivorship care coached by a study-specific nurse. The primary hypotheses are improved symptom burden and quality of life improvement. Secondary hypotheses are that the intervention is cost-effective and increase survival.
This study will be performed in primary health care within the Stockholm County Council, Sweden. There are around 200 Primary Health Care Centers (PHCC) in Stockholm. Cluster randomization of the PHCC will be used. To achieve representative PHCCs for randomization a Care Need Index (CNI) is used. CNI is a model that measures healthcare needs for the distribution of primary care resources to the population with the biggest need. Based on CNI and population number four PHCC units with high CNI index (low socioeconomic status) and four PHCC with low CNI index (high socioeconomic status) will be selected. A matched pair randomization stratified design will be used which is often preferable when randomizing numbers of clusters. In total 70 patients will receive the intervention and standard care and 70 patients in a control group receiving standard care.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •patients with prostate cancer at the end of curative treatment
- •able to read and understand Swedish
- •considered being physically, psychologically and cognitively able to participate in the study
排除标准
- 未提供
研究组 & 干预措施
Intervention
The intervention consists of standard care and an app for routine symptom reporting, weekly the first month and thereafter as mutually agreed, at minimum once a month in one year, with instant self-managment advice in combination with supportive care with a study-specific nurse. At health dialogues with the nurse, the patient-reported assessments in the app will be used to discuss the individual's current situation and to plan eventual additional actions needed. The intervention will last for 6 months.
干预措施: Interactive app (Device)
Intervention
The intervention consists of standard care and an app for routine symptom reporting, weekly the first month and thereafter as mutually agreed, at minimum once a month in one year, with instant self-managment advice in combination with supportive care with a study-specific nurse. At health dialogues with the nurse, the patient-reported assessments in the app will be used to discuss the individual's current situation and to plan eventual additional actions needed. The intervention will last for 6 months.
干预措施: Supportive Care (Other)
Control
The participants in the control group will only receive standard care. Usually after ended curative treatment the follow-up is a blood sample (PSA) every three or six months the first year, this can be handled either by a nurse or a physician in secondary care. Most hospitals also have one physical meeting with a physician three months after ended treatment (Regional Cancer Centers, 2020). All patients are allocated a contact nurse with a telephone number to contact when needed.
结局指标
主要结局
Acceptability E -scale
时间窗: 6 months
The Acceptability e-scale is a questionnaire with 6 items that evaluate the acceptability of a system. Items are scored using a Likert scale ranging from 1-5 with higher values indicating higher acceptability.
System Usability Scale (Q5 and Q10)
时间窗: 6 months
The System Usability Scala is a questionnaire with ten item that evaluate the usability of a system. Items are scored using a Likert scale ranging from 1-5. Only question 5 and 10 will be included in this study.
Interviews
时间窗: 7 months
To assess acceptability and feasibility, the participants in the intervention group and the study specific nurses will be interviewed about their experinece using the Interaktor system and about the health dialouges.
Other feasibility measures
时间窗: Through study completion, an avrage of 24 months
To evaluate the feasibility of the future trial methodology, enrollment, recruitment, and withdrawal rates will be documented. Other feasibility measures include completion rates and missing data in each study questionnaire. Objective measures will be extracted from the logged data in the app, i.e., the number of reports sent (adherence), self-managment advice viewings, and notes from the study-specific nurses.
次要结局
- Symptom burden measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Prostate Module(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Quality of Life measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- The Patient Activation Measure (PAM -13)(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Quality of life measured measured by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L)(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- The Sence of Coherence Scale (SOC-13)(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Health Literacy CCHL (5-items)(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
研究者
Ann Langius-Eklöf
Professor
Karolinska Institutet