Malignant Wounds: A Randomized Clinical Trial Investigating a Complementary Multidimensional Intervention
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Wound size
研究概览
简要总结
The purpose of this study is to investigate whether treatment for cancer patients with malignant wounds can improve (wound healing/wound size, odor, infection, seepage, pain) through comparing the effects of two multidimensional interventions including wound treatment, psycho-social support and relaxation therapy.
详细描述
Objective: To investigate whether treatment for cancer patients with malignant wounds can improve (wound healing/wound size, odor, infection, seepage, pain) through comparing the effects of two multidimensional interventions:
- wound treatment (silver product, alginate and foam dressing >< honey product, alginate and foam dressing) in combination with,
- psycho-social support (based on the structure in cognitive therapy) and
- relaxation therapy.
Furthermore to investigate coping strategies, body image, stigma and quality of life in cancer patients with malignant wounds.
Design: A hypothesis testing prospective randomized clinical intervention study (n=70) and an explorative qualitative interview study
Method: Digital photographing, measurement of wound size with Quantify-Image-One, wound morphology registration (the extent of malodour, infection, seepage, bleeding, pain, the healing process), grafting, VAS-score, quality of life questionnaire (EORTC-QLQ-C30, DLQI), Hospital Anxiety and Depression Scale (HAD), Mental Adjustment to Cancer (MAC), interview.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer with evidence of disease.
- •Cancer wound >2 cm.
- •Receiving antineoplasm treatment.
- •> 18 years.
- •Receiving antineoplasm treatment in out-patient clinic.
- •Read, speak and write Danish.
排除标准
- •No radiation therapy the last 6 month (on the wound).
- •Life expectancy > 3 month.
- •Not psychotic.
结局指标
主要结局
Wound size
时间窗: after four weeks intervention period
次要结局
- Wound odor. Wound infection. Wound exudate. Wound pain. Anxiety and depression. Body-Image.Sexuality.Quality of life.(after the four week intervention period)