Mind-body Online Therapy in a Somatic Setting - a Randomized-controlled, Two-arm, Monocentric Study in Gynecological Oncology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- General distress
研究概览
简要总结
In this randomized-controlled two-arm monocentric study with three measurement time points, the effectiveness and feasibility of an internet-based, therapist-guided mind-body self-help intervention for gynecological cancer patients with primary diagnoses is examined. Different modules (e.g., relaxation, mindfulness, stress management, disease management, nutrition and exercise behaviors) with a mind-body focus are available for the patients. The goal of the intervention is to improve or maintain the quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •At least 18 years old
- •Oncologic disease: first diagnosed; within the first 12 weeks of diagnosis, first-line treatment (either systemic treatment - including chemotherapy, hormonal therapy or targeted therapy - or radiotherapy), Notes: (1) Patients treated for first recurrence of a tumor previously treated with curative intent are also eligible. (2) Psychological distress is taken into account by stratification according to the stress thermometer. In research, this procedure corresponds to the current state-of-the-art. Individual subgroups (e.g. cancer stages) can then be studied post-hoc.
- •Sufficient computer skills and internet access
- •Availability of an emergency address
- •Written informed consent by signing the informed consent form
排除标准
- •Patient unable to provide written informed consent by signing informed consent form
- •Insufficient knowledge of German
- •Moderate to severe depressive symptomatology (BDI > 18; HAM-D17 ≥ 17) during T1 survey
- •Suicidality (BDI suicidality item > 1; HAM-D17 suicidality item ≥ 2) in the context of the T1 survey
- •Diagnosis of psychotic, bipolar, or other serious mental or somatic disorder requiring immediate treatment
- •Male breast cancer patients
结局指标
主要结局
General distress
时间窗: Week 0, Week 8, Week 16
German version of the questionnaire "Distress Thermometer" (BTH; Mehnert et al., 2006)
Insomnia (Severity)
时间窗: Changes between week 0, 8, 16
German version of the questionnaire "Insomnia Severity Index" (ISI; Morin, 1993)
Anxiety and depression
时间窗: Changes between week 0, 8, 16
German version of the questionnaire "Hospital Anxiety and Depression Scale" (HADS; (Herrmann et al., 1995; Herrmann-Lingen et al., 2011)
Impairment from cancer therapy
时间窗: Changes between week 0, 8, 16
German version of the questionnaire "Functional Assessment of Cancer Therapy" (FACT-G; Cella \& Bonomi, 1996; Cella et al., 1993)
SpO2 [%]
时间窗: Changes between week 0, 8, 16
Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)
Depression (external assessment)
时间窗: Changes between week 0, 8, 16
German version of the questionnaire "Hamilton Depression Scale" (HAM-D17; Hamilton, 1960; Hamilton, 1986)
Somatization
时间窗: Changes between week 0, 8, 16
German version of the questionnaire "Patient Health Questionnaire" (PHQ-9; Gräfe et al., 2004; Kroenke et al., 2010)
Psychological stress
时间窗: Changes between week 0, 8, 16
German version of the questionnaire "Symptom Checklist" (SCL-K11; Franke, 2001; Franke, 2002)
Sleep quality
时间窗: Changes between week 0, 8, 16
German version of the questionnaire "Pittsburgh Sleep Quality Index" (PSQI; Buysse et al., 1989; Carpenter \& Andrykowski, 1998)
Health-related quality of life
时间窗: Changes between week 0, 8, 16
German version of the questionnaire "Short Form 12" (SF-12; Morfeld et al., 2012)
Peripheral arterial tone (PAT) [mmHG]
时间窗: Changes between week 0, 8, 16
Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)
次要结局
- Feasibility of the intervention (Patient satisfaction)(Changes between week 8, 16)
- Feasibility of the intervention (Patient-therapist relationship)(Changes between week 8, 16)
- Feasibility of the intervention (Usability)(Changes between week 8, 16)
研究者
Katja Haemmerli Keller
Principal Investigator
Cantonal Hospital of St. Gallen