Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 754
- 试验地点
- 15
- 主要终点
- Patients' score on the Health Education Impact Questionnaire (HEI-Q)
研究概览
简要总结
This study compares traditional follow-up of gynaecological cancer patients to an alternative follow-up model. In the alternative follow-up model the patients will meet a nurse at every second consultation. The nurse will focus on psychosocial health and educate the patients in the use of a study specific smartphone-application.
详细描述
The goal is to improve follow-up of past and present cancer patients to have the best quality of life possible, despite having a serious illness. Todays' survivors differ from the survival population for whom the traditional follow-up was designed. Improvements in treatment assure that many cancer patients survive longer after diagnosis often with age-related comorbidities. Consequently, new evidence-based models for follow-up after cancer treatment with focus on techniques to improve coping with and management of late effects without increasing the costs are warranted. The chronic care model, which uses self-management interventions, is used for many chronic diseases-such as diabetes and asthma and is a valid model to consider for cancer follow-up care(1). Another relevant model is the risk stratified model where patients are stratified into low, moderate, or high-risk on the basis of expected recurrence rate and late-effects(2). Gynecological cancer patients constitute an underrepresented group in clinical cancer research.
The research group has developed a follow-up model based on the principles of the risk-stratified model and the chronic care model with one or three year's hospital follow-up for low- versus medium/high-risk patients. Physicians will be replaced by nurses in 50% of the consultations. The nurses will use evidence-based behavior change techniques to coach the cancer patients on how to take an active role in management of their physical and mental late effects. These techniques will be further reinforced with a multifunctional smart phone-application (app). The "Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology-app" (LETSGO-app) has three main functions: 1) Self-evaluated symptoms (on recurrence or late effects) regularly reported through the app; 2) Targeted information on treatment, signs of recurrence, and late-effects on each cancer type and 3) Facilitation of early rehabilitation through physical activity instructions, goal-setting and electronic reminders.
The investigators will conduct a multicenter study including 754 cancer survivors in Norway. Ten Norwegian hospitals will participate whereof five hospitals are intervention hospitals and five are control hospitals.
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
- •Histologically verified gynaecological cancer
- •Cervical cancer restricted to squameous cell carcinoma, adeno carcinoma and adeno-squameous carcinoma) or
- •Endometrial cancer or
- •Ovarian cancer (restricted to epithelial type) or
- •Vulvar cancer
- •Must have completed primary treatment and scheduled to follow-up
排除标准
- •Participating in other cancer treatment trial or follow-up trial
- •Cervical cancer patients treated with trachelectomy
- •On maintenance therapy
- •Dementia or other mental/cognitive impairment
- •Illiterate in Norwegian
结局指标
主要结局
Patients' score on the Health Education Impact Questionnaire (HEI-Q)
时间窗: Assessed right after initial treatment, and 3, 6, 12, 24 and 36 months after treatment
Evaluating the immediate effects of self-management interventions in cancer follow-up. It contains the following domains: Health-directed activities, Positive and active engagement in life, Emotional distress, Constructive attitudes and approaches, Self-monitoring and insight, Skill and technique acquisition, Social integration and support, Health service navigation. Individuals are asked to indicate their level of agreement with 42 statements across the eight domains on four-point Likert scales (1 "strongly disagree" to 4 "Strongly agree"). Higher scores indicate greater performance of specific self-management behaviors. Higher scores on the emotional well-being domain denote higher levels of negative affect. Data from each domain will be used individually and the results reported as mean domain score. The primary outcome is the change of the insight subscale scores of the HEI-Q from right after treatment (baseline) to 12 months after treatment.
次要结局
- Patients' score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), measuring ´Health related quality of life (HRQL)(Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively)
- Changes in physical activity level based on International Physical Activity Questionnaire - Short Form (IPAQ)(Change from baseline to 12, 24 and 36 months after completion of primary treatment)
- Frequency of health care use(Change from baseline to 36 months after completion of primary treatment)
- Time to recurrence(Differences between intervention group and control group at 60 months after completion of primary treatment)
- Impact of physical activity changes on insulin biomarkers in blood(Change from baseline to 36 months after completion of primary treatment)
- 4.Cancer type specific quality of life using the EORTC Cervical Cancer Module (EORTC QLQ-CX24)(Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively)
- Survival(Differences between intervention group and control group at 60 months after completion of primary treatment)
- Change adherence to physical activity recommendations(Change from baseline to 12, 24 and 36 months after completion of primary treatment)
- Physical activity goals(Change from baseline to 12, 24 and 36 months after completion of primary treatment)
- Patients' score on the Health Education Impact Questionnaire (HEI-Q)(Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively)
- Differences in expression of biomarkers in cancer tissue in relation to recurrence of disease(Compare differences between patients with and without recurrence at 36 months after completion of primary treatment)
- Examination of Circulating tumor DNA (ctDNA) at the point of disease progression compared with 3 months values(At 3 months and at progression)
- 4.Cancer type specific quality of life using the EORTC Endometrial Cancer Module (EORTC QLQ-EN24)(Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively)
- Changes in the use of a study specific smartphone application(36 months after completion of primary treatment)
- Costs-effectiveness using the EuroQol 5-Dimensional (EQ5D)(Change from end of treatment (baseline) to 36 months after completion of primary treatment)
- Impact of physical activity changes on inflammatory biomarkers in blood(Change from baseline to 36 months after completion of primary treatment)
- 4.Cancer type specific quality of life using the EORTC Ovarian Cancer Module (EORTC QLQ-OV28)(Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively)
- 4.Cancer type specific quality of life using the EORTC Vulvar Cancer Module (EORTC QLQ-VU34)(Questionnaires are administered at end of treatment, 3, 6, 12, 24 and 36 months after treatment, respectively)
研究者
Ingvild Vistad
Professor
Sorlandet Hospital HF