To Live Better After Breast Cancer Treatment - a Randomized Pilot Trial of a Supportive and Person-centered Care Intervention in Primary Healthcare
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Interviews with patients and study-specific nurses
研究概览
简要总结
The most common cancer among women in Sweden is breast cancer. Advances in treatment have improved survival, but these advances have come at a steep price since most treatments impose substantial morbidity and burden on patients and their families. 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 person-centered care where the patient is a participatory member of the team. This study aims to pilot-test a supportive and person-centered care intervention in primary healthcare for six months during the first year after primary treatment for breast cancer, assisted by digital technology and compare it to standard care only. The intervention consists of symptom reporting and management in an app in combination with health dialogues with a study-specific nurse at the Primary healthcare centre.
详细描述
The incidence rate of breast cancer has increased during the past decades and has surpassed lung cancer as the most frequently diagnosed type of cancer worldwide. In Sweden, it is the most common cancer among women and in 2021, 8 616 women received a diagnosis, the ten-year survival rate is over 87%. The overall increase in survival rates can be explained by population-based mammography screening, early detection, and advancements in treatment. The negative impact of treatment on patients' quality of life (QoL) has been established as important to consider in the adjuvant treatment setting of operable breast cancer. Furthermore, several treatments are given over longer periods; e.g. anti-hormonal treatments are prescribed for up to 10 years after a breast cancer diagnosis. As the number of patients with breast cancer increases, so does the demands on the healthcare services throughout the whole cancer trajectory.
Patient-reported outcome (PRO) is an outcome that is reported by the patients. Previous research on collecting PRO:s 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 survival. Current research emphasizes the importance of user involvement in the development phase of web-based interventions and that its content is specific to the patient´s needs as well as delivered at the right stage in the cancer trajectory.
The aim is to pilot- test routine assessment of patient's reported symptoms and support in self-management assisted by digital technology for six months during the first year after primary treatment for breast cancer in combination with health dialogues with a study-specific nurse at the Primary healthcare centre. The primary objective is to evaluate the acceptability and feasibility of a digital and nurse-led support intervention in primary healthcare for patients with breast cancer during the first year after primary treatment. The secondary objectives of this trial are to (i) evaluate the potential efficacy of the intervention, (ii) obtain estimates for secondary outcome measures and potential mediators and moderators to be used in a future trial and (iii) evaluate the feasibility of such assessments.
There are 250 PHCCs within the region and to achieve representativeness for randomization the Care Need Index (CNI) for calculating economic compensation to the PHCC is used. It measures healthcare needs for the distribution of primary care resources to the population with the biggest need. A high CNI index equals low socioeconomic status, and a low CNI index equals high socioeconomic status. The intervention involves the entire PHCC and cluster randomisation is used to avoid a spill-over effect. Approximately ten PHCCs will be matched on CNI index and the number of patients allocated to the PHCCs.
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
- •patients with breast 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
结局指标
主要结局
Interviews with patients and study-specific nurses
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 experience of using the Interaktor system and about the health dialogues.
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 Scale is a questionnaire with ten items 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.
Other feasibility measures
时间窗: Through study completion, an average 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-care 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 - C30.(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.)
- 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.)
- Patient Activation Measure (PAM-13)(Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.)
- The Sense of Coherence Scale (SOC-13)(Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.)
- Symptom burden measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module BR45.(Baseline, 3 months, 6 months, 12 months, 18 months and 24 months.)
研究者
Ann Langius-Eklöf
Professor
Karolinska Institutet