Person-centred Support for Women in the Follow-up Period After Surgical Treatment for Gynaecological Cancer - a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Primary Outcome: Quality of life measured by the scale Quality of life- Cancer Survivors (QOL-CS)
研究概览
简要总结
Women treated for gynaecological cancer perceive many difficulties in life on the personal, social, and physical levels. Today they are offered a 3 to 5 year follow-up programme at the hospital where the main purpose is to improve survival. However, the women are very nervous before follow-up visits and although they feel safe about them, they express that their needs of psychosocial care and self-management support are not fulfilled.
The proposed study will test a person-centred intervention tailored the women's needs in a randomised controlled trial. The intervention will be based on the method Guided Self Determination (GSD), which has proved able to realize empowerment in practice in relationships between patients and healthcare professionals. GSD involves systematic use of condition-adjusted worksheets ('reflection sheets'), and advanced professional communication. Using reflection sheets filled out by each woman as the starting point for communication, problem solving will be tailored her personal needs. We expect that the intervention has the potential to support the women in better managing specific complications and difficulties related to concerns about recovery, body perception, fertility and establishment of intimate relations with their partner, all aspects important for the women's quality of life in the follow-up period after cancer diagnosis and treatment. The study will be the first to test GSD in cancer patients.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women only surgically treated for cervix, ovarian (including borderline tumors), endometrial or vulva cancer, who attend follow up at the Gynaecological Department at The University Hospital Rigshospitalet in Copenhagen.
- •The women should read, write and understand the danish language.
- •Exclusion criteria:
- •Known recurrence.
- •Participation in the preliminary pilotstudy.
- •Health related problems both physical or psychological, that prevent participation. For example cognitive impairment, or patients with psychiatric diseases that is estimated to require nurses with competences within the psychiatric speciality.
排除标准
- 未提供
结局指标
主要结局
Primary Outcome: Quality of life measured by the scale Quality of life- Cancer Survivors (QOL-CS)
时间窗: 9 months after randomisation
+/- one week for practical reasons
次要结局
- Symptom monitoring and recognition(3 and 9 months after randomisation (+/- one week for practical reasons))
- Quality of Life measured by the scale Quality of Life Cancer Survivors- (QOL-CS)(3 months after randomisation)
- Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)(3 and 9 months from randomisation)
- Changes in Quality of life in the two groups(9 months)
- Self-esteem measured by Rosenbergs Self Esteem Scale(3 and 9 months after randomisation)
- Autonomy-supportive relationship between patient and health care professionals measured by Health Care Climate Questionnaire (HCCQ)(3 and 9 months from randomisation)
- Distress measured by Distress Thermometer(DT).(3 and 9 months from randomisation)
- Positive and negative impact of cancer measured by Impact of Cancer version 2 (IOCv2)(3 and 9 months after randomisation)
研究者
Mette Linnet Olesen
Ph.d student
Rigshospitalet, Denmark