Needs Assessment and Decision-making Tool (NEAT-decision) Integrated in a Clinical Practice to Enhance Patient Involvement in Head and Neck Cancer Rehabilitation - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Change in Health Related Quality of Life, from baseline to 9, 21 and until 67 days post surgery
研究概览
简要总结
The study tests a needs assessment and decision-making tool with patients who are in need of rehabilitation after surgery for Head and Neck Cancer. The purpose is to enhance patient involvement in decision-making.
详细描述
The study tests a needs assessment and decision-making tool with patients surgically treated for Head and Neck Cancer. The tool will be an integrated part of a new clinical practice with nursing consultations at three seperate time-points in the post-surgical period of the patients. Half of the participants will receive nursing consultations using the tool and the other half will receive standard care.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Head and Neck Cancer
- •Stage T3 or T4
- •Surgically treated
- •Must be able to speak and understand Danish
排除标准
- •Treated surgically for thyroid or parotic cancers
- •Referred to adjuvant radio - or chemotherapy
- •Having an unstable psychiatric illness.
研究组 & 干预措施
Intervention Group (IG)
Patients receive needs assessment tool integrated in nursing consultation in accordance with requirements by Danish Health and Medicine Board follow-up program for HNC patients. The consultation consists of 6 steps 1. Welcoming patient; 2. Introducing patient to assessment tool; 3. Discuss symptoms and concerns patient wishes to discuss; 4. Follow up on patients symptoms, concerns and emotional reactions/problems; 5. Accompany/support patient during appointment with surgeon and in cooperation with patient and surgeon ensure that problems arising from the tool needing medical attention are focused on; 6. Continue the consultation after appointment with surgeon; refer patient to multi-disciplinary team members when needed
干预措施: Needs assesment tool integrated in nursing consultation. (Other)
Control Group (CG)
CG will receive standard care according to the Danish Health and Medicine Board's follow-up program for HNC patients. At present this is done by a staff nurse interviewing the patient, who is a member of the rehabilitation team who perform nursing consultations. The interview takes place after the appointment with the surgeon. The nurse refers the patient to physical rehabilitation if needed
结局指标
主要结局
Change in Health Related Quality of Life, from baseline to 9, 21 and until 67 days post surgery
时间窗: Baseline; 9; 21 and 67 days post-surgery
Questionnaire measuring 35 items related to quality of life in head and neck cancer. European Organisation for Research and Treatment of Cancer Quality of Life and Head and Neck Cancer (EORTC QLQ-H\&N35). Scores range from 0 - 100,, where a high score represents high quality of life. The study will measure global quality of life
次要结局
- Change in Symptom Burden from baseline to 2, 14 and 60 days post-surgery(Baseline, 2, 14 and 60 days post-surgery)
研究者
Annelise Mortensen
PhD student
Rigshospitalet, Denmark