Web-based Stress Management for Newly Diagnosed Cancer Patients (STREAM-1): A Randomized, Wait-list Controlled Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Characteristics (Sociodemographic and medical history; i.e. age, gender, education, cancer diagnosis and cancer treatment) of the population willing to participate in an online stress management program shortly after diagnosis of cancer
研究概览
简要总结
Many cancer patients experience their illness as substantial psychological burden. About half of the cancer patients suffer from severe stress symptoms and around one third of the patients fulfill the criteria for a clinically relevant psychological disorder (mainly anxiety disorder and/or major depression). Studies show, that a high level of distress in cancer patients is associated with more side effects of and a reduced compliance for oncological treatment.
Today, the efficacy of psycho-oncological interventions is well studied and proven. Besides the reduction of levels of anxiety, distress and depression, psycho-oncological support facilitates dealing with physical complaints and increases quality of life. Yet, psycho-oncological support is rarely utilized by male patients and insufficiently accessible for many patients (i.a. lack of supply in the respective area, cost issues).
The internet overcomes some of these barriers, as it can be used independently of time and location. Internet-based therapies are therefore a growing field of interest in research and there is evidence for treatment efficacy for several psychological disorders. Moreover effect sizes of traditional face-to-face and interactive web-based interventions are comparable. However, web-based interventions for cancer patients are still scarce. The present research project therefore develops a comprehensive stress management program accessible for a vast number of cancer patients. The study targets primarily to evaluate the feasibility of the program (technical, organizational feasibility, accessibility). In addition, the preliminary efficacy of the program will be analyzed in order to adapt future programs for specific patient groups.
详细描述
The present study is designed as a randomized controlled wait-list intervention study. Within 12 weeks of the start of anti-cancer treatment, patients will be randomly assigned to the web-based stress management intervention or a wait-list control condition.
Inclusion criteria:
Patients with any kind of newly diagnosed cancer undergoing first Treatment regardless of the Setting. Patients undergoing first treatment for newly diagnosed relapse of cancer, who have received prior curatively-intended Treatment.
Inclusion is allowed immediately prior to or within 12 weeks of the start of treatment. If surgery was performed initially and is followed by systemic treatment or radiotherapy, start of systemic treatment or radiotherapy is counted as first treatment. Prior treatment -including chemotherapy- for a different, prior malignant tumor is allowed. Concomitant participation in an experimental therapeutic drug trial is allowed. Age >18 years. Command of the German language. Internet access and basic computer skills. Life expectancy of >6 months.
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 any kind of newly diagnosed cancer undergoing first treatment (including radiotherapy, hormonal treatment, targeted therapies, chemotherapy or combined-modality treatment) regardless of the setting (adjuvant treatment, curative treatment, palliative first-line treatment)
- •Patients with newly diagnosed relapse of cancer, who had received prior curatively-intended treatment
- •Inclusion is allowed immediately prior to or within 12 weeks of the start of treatment
- •Patients must have cytologically or histologically proven diagnosis of malignant disease (either at diagnosis or at relapse)
- •Prior treatment -including chemotherapy- for a different, prior malignant tumor is allowed
- •Concomitant participation in an experimental therapeutic drug trial is allowed
- •Age >18 years
- •Command of the German language
- •Internet access and basic computer skills
- •Life expectancy of >6 months
排除标准
- •Patients undergoing palliative second- or further line chemotherapy treatment
- •Patients treated with surgery only
- •Patients participating in a concomitant psychological intervention trial
结局指标
主要结局
Characteristics (Sociodemographic and medical history; i.e. age, gender, education, cancer diagnosis and cancer treatment) of the population willing to participate in an online stress management program shortly after diagnosis of cancer
时间窗: Measures assessed at time point of recruitment
Usability scores on the System Usability Scale (SUS)
时间窗: participants will be followed for the duration of the intervention, an expected average of 8 weeks
Number of participants who completed at least 6 out of 8 modules, i.e. 75 % of each module
时间窗: participants will be followed for the duration of the intervention, an expected average of 8 weeks
Working Alliance scores on the Working Alliance (WAI) Questionnaire
时间窗: participants will be followed for the duration of the intervention, an expected average of 8 weeks
Client satisfaction on the Client Satisfaction Questionnaire-8 (CSQ-8)
时间窗: Measures assessed after 8 weeks
German Version of the Client Satisfaction Questionnaire: Fragebogen zur Messung der Patientenzufriedenheit (ZUF-8) will be used
Dropout rate during the internet-based recruitment procedure
时间窗: Measures assessed at time point of recruitment
次要结局
- Anxiety and Depression scores on the Hospital Anxiety and Depression Scale (HADS)(Change measures (e.g., "baseline, 8 weeks"))
- Quality of life and fatigue scores on the Functional Assessment in Cancer Therapy-Fatigue (FACT-F)(hange measures (e.g., "baseline, 8 weeks"))
- Psychological distress on the Distress Thermometer (visual analogue scale)(Change measures (e.g., "baseline, 8 weeks"))
- Avoidance and psychological inflexibility scores on the Acceptance and Action questionnaire (AAQ)(ange measures (e.g., "baseline, 8 weeks"))