SerenApp Project: Protocol for a Pilot Study and Co-Creation of a Digital Tool for Psychological Support in Women Under Follow-Up and Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in Stress Coping Strategies
研究概览
简要总结
This study will design, test, and evaluate SerenApp, a digital health tool created to support women after completing treatment for breast cancer. Many women live for many years after breast cancer, but a large number continue to experience emotional difficulties such as anxiety, sadness, stress, or fear of the cancer coming back. These problems can strongly affect quality of life and are often not addressed during routine medical visits.
SerenApp is being developed as a safe, easy-to-use mobile application that provides psychological support and practical resources to help breast cancer survivors manage these challenges. What makes this project different is that the app will be created together with patients and healthcare professionals, to ensure that it responds to real needs and is adapted to the public health system in Spain.
The main questions of the study are:
Can SerenApp help women feel less anxious, depressed, or stressed and improve their overall quality of life?
Will women and professionals find the app useful, acceptable, and easy to use?
Could this digital tool reduce the need for additional healthcare resources and be cost-effective for the health system?
详细描述
The project has two main parts:
Co-creation phase:
Women who have had breast cancer and healthcare providers (such as oncologists, nurses, and psychologists) will participate in workshops and group discussions.
They will share their experiences, identify needs, and help design the functions and content of the app.
This ensures that the final product is adapted to what patients and professionals really want and need.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥18 years.
- •History of breast cancer with completion of primary treatment (surgery, chemotherapy, and/or radiotherapy), currently in follow-up.
- •Access to a smartphone or tablet with internet connection.
- •Ability to understand and provide written informed consent.
- •Sufficient knowledge of Spanish to use the app and complete questionnaires.
排除标准
- •Current recurrence or metastatic breast cancer.
- •Severe cognitive impairment or psychiatric disorder that may interfere with participation (e.g., psychosis, severe dementia).
- •Concurrent participation in another psychosocial intervention study.
- •Lack of access to digital devices or inability to use mobile applications.
研究组 & 干预措施
Usual Oncological Follow-up
Participants in this group will continue to receive standard oncological follow-up care according to routine clinical practice, without access to SerenApp during the study period. They will complete the same baseline and post-intervention assessments as the intervention group, which will allow comparison of psychological, quality of life, and healthcare resource outcomes.
SerenApp Intervention
Participants in this group will receive access to SerenApp for 8 weeks. SerenApp is a co-designed digital mental health application for breast cancer survivors, aimed at reducing stress, anxiety, and depressive symptoms, and enhancing coping strategies and empowerment. Participants will be encouraged to engage with the app modules during the study period and will complete baseline and post-intervention assessments, including validated psychological and usability measures.
干预措施: SerenApp Digital Psychological Intervention (Device)
结局指标
主要结局
Change in Stress Coping Strategies
时间窗: Baseline (T0) and 8 weeks (T1)
The CAEPO assesses cognitive and behavioral coping strategies used by oncology patients to manage stress related to their disease. It includes 40 items across seven subscales: Confrontation and Active Fighting, Self-Control and Emotional Control, Seeking Social Support, Anxiety and Anxious Worry, Passivity and Passive Resignation, Escape and Distancing, and Denial. Each item is rated on a 4-point Likert scale (0-3), with higher scores indicating greater use of each coping strategy.
Change in Anxiety Symptoms
时间窗: Baseline (T0, before intervention) and 8 weeks post-intervention (T1)
Measured using the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A), this outcome evaluates changes in anxiety symptom severity in breast cancer survivors. The HADS-A consists of 7 items rated on a 0-3 Likert scale, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety symptoms.
Change in Depressive Symptoms
时间窗: Baseline (T0) and 8 weeks (T1).
Depressive symptoms will be assessed with the Patient Health Questionnaire-9 (PHQ-9), a validated 9-item scale widely used in oncology and primary care. Higher scores indicate more severe depression. Total Score: 0-27
次要结局
- Change in Health-Related Quality of Life(Baseline (T0) and 8 weeks (T1))
- Usability of SerenApp(8 weeks (T1, post-intervention only).)
- Satisfaction with Care(8 weeks (T1))