Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer - a Clinical Trial Evaluating and Implementing a Model for Evidence-based Cancer Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- General Quality of life
研究概览
简要总结
This study aims to develop and evaluate a model for systematic and evidence-based cancer rehabilitation for people with esophageal and gastric cancer to provide conditions for a better quality of life and fewer cancer-related symptoms.
详细描述
Sweden has had a National Cancer Rehabilitation Programme since 2014. This emphasises that all people with cancer have the right to individualised rehabilitation and that the contact nurse has an important role to play in identifying needs and ensuring evidence-based interventions throughout the cancer process to promote rehabilitation. The needs for optimised rehabilitation vary according to several parameters such as the person's personal circumstances and preferences, social support and type of cancer disease.
Despite this and a growing number evidence within this area cancer rehabilitation is often not integrated in clinical care. The current cancer care focuses on medical and treatment related interventions. It is a challenge for health services to find models to identify and meet the increased need for cancer rehabilitation in a systematic and structured way throughout the cancer process, based on the specific needs of each individual. This study aims to develop and evaluate a model for systematic and evidence-based cancer rehabilitation for people with esophageal and gastric cancer to provide conditions for a better quality of life and fewer cancer-related symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •over 18 years of age
- •esophageal or gastric cancer
- •living in Southern Sweden (Skåne)
- •are planned to undergo curative surgerytreatment at Skåne University Hospital.
排除标准
- •unable to communicate in the Swedish language
- •suffering from a cognitive impairment that poses a barrier for participating in the study.
研究组 & 干预措施
Experimental group
Patients over 18 years of age with esophageal or gastric cancer, who are living in Southern Sweden, and who are planned to undergo curative surgery treatment at Skåne University Hospital. n=100 (anticipated)
干预措施: evidence-based individualized rehabilitation (Other)
Historical control group
The historical control group consists of patients, living in Southern Sweden, who underwent esophageal or gastric cancer surgery between 2013 - 2021 at Skåne University Hospital. n=100 (anticipated)
结局指标
主要结局
General Quality of life
时间窗: Instrument will be answered by the patient after surgery at 12 months postoperative
The instrument QLQ-C30 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measures quality of life. The instrument has a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit 4=very much). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status/QoL scale, and six single items. All of the scales and single-item measures in score from 0-100. A high scale score represents a higher response level. A high score for functional scale represents a high/healthy level of functioning. A high score for global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.
General Quality of life
时间窗: Instrument will be answered by the patient at baseline (at treatment decision)
The instrument QLQ-C30 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measures quality of life. The instrument has a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit 4=very much). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status/QoL scale, and six single items. All of the scales and single-item measures in score from 0-100. A high scale score represents a higher response level. A high score for functional scale represents a high/healthy level of functioning. A high score for global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.
General Quality of life
时间窗: Instrument will be answered by the patient at approximately 1 week preoperative
The instrument QLQ-C30 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measures quality of life. The instrument has a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit 4=very much). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status/QoL scale, and six single items. All of the scales and single-item measures in score from 0-100. A high scale score represents a higher response level. A high score for functional scale represents a high/healthy level of functioning. A high score for global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.
General Quality of life
时间窗: Instrument will be answered by the patient after surgery at 6 months postoperative
The instrument QLQ-C30 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measures quality of life. The instrument has a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit 4=very much). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status/QoL scale, and six single items. All of the scales and single-item measures in score from 0-100. A high scale score represents a higher response level. A high score for functional scale represents a high/healthy level of functioning. A high score for global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.
次要结局
- Esophageal and gastric cancer specific Quality of life(Instrument will be answered by the patient after surgery at 12 months postoperative)
- International Physical Activity Questionnaire(Instrument will be answered by the patient after surgery at 12 months postoperative)
- Resilience(Instrument will be answered by the patient after surgery at 12 months postoperative)
- Psychological Distress(Instrument will be answered by the patient after surgery at 12 months postoperative.)
- Sickness absence/work(Instrument will be answered by the patient after surgery at 12 months postoperative.)
- Information needs(Instrument will be answered by the patient after surgery at 12 months postoperative.)
- Assessment of Survivorship Concerns(Instrument will be answered by the patient after surgery at 12 months postoperative)
- Assessment of rehabilitation needs.(Instrument will be answered by the patient after surgery at 12 months postoperative)
- Tobacco use(Single item questions will be answered by the patient after surgery at 12 months postoperative.)
- Weight(Single item question will be answered by the patient after surgery at 12 months postoperative.)
- Body Mass Index (BMI)(Instrument will be answered by the patient after surgery at 12 months postoperative.)
- Alcohol use(Single item questions will be answered by the patient after surgery at 12 months postoperative.)
- Dysphagia(Instrument will be answered by the patient after surgery at 12 months postoperative.)
- Rehabilitation process(Instrument will be answered by the patient after surgery at 12 months postoperative.)
- Hospital Anxiety and Depression Scale(Instrument will be answered by the patient after surgery at 12 months postoperative)
- Height(Single item question will be answered by the patient at baseline (at treatment decision).)
- Physical activity(Single item question will be answered by the patient after surgery at 12 months postoperative.)
- Esophageal and gastric cancer specific Quality of life(Instrument will be answered by the patient at baseline (at treatment decision))
- Esophageal and gastric cancer specific Quality of life(Instrument will be answered by the patient at approximately 1 week preoperative)
- Esophageal and gastric cancer specific Quality of life(Instrument will be answered by the patient after surgery at 6 months postoperative)
- Information needs(Instrument will be answered by the patient at baseline (at treatment decision))
- Information needs(Instrument will be answered by the patient at approximately 1 week preoperative)
- Information needs(Instrument will be answered by the patient after surgery at 6 months postoperative)
- International Physical Activity Questionnaire(Instrument will be answered by the patient at baseline (at treatment decision))
- Resilience(Instrument will be answered by the patient at approximately 1 week preoperative)
- International Physical Activity Questionnaire(Instrument will be answered by the patient at approximately 1 week preoperative)
- International Physical Activity Questionnaire(Instrument will be answered by the patient after surgery at 6 months postoperative)
- Hospital Anxiety and Depression Scale(Instrument will be answered by the patient at baseline (at treatment decision))
- Hospital Anxiety and Depression Scale(Instrument will be answered by the patient at approximately 1 week preoperative)
- Hospital Anxiety and Depression Scale(Instrument will be answered by the patient after surgery at 6 months postoperative)
- Assessment of Survivorship Concerns(Instrument will be answered by the patient at baseline (at treatment decision))
- Assessment of Survivorship Concerns(Instrument will be answered by the patient at approximately 1 week preoperative)
- Assessment of Survivorship Concerns(Instrument will be answered by the patient after surgery at 6 months postoperative)
- Resilience(Instrument will be answered by the patient at baseline (at treatment decision))
- Resilience(Instrument will be answered by the patientafter surgery at 6 months postoperative)
- Assessment of rehabilitation needs.(Instrument will be answered by the patient at baseline (at treatment decision))
- Assessment of rehabilitation needs.(Instrument will be answered by the patient at approximately 1 week preoperative)
- Assessment of rehabilitation needs.(Instrument will be answered by the patient after surgery at 6 months postoperative)
- Psychological Distress(Instrument will be answered by the patient at baseline (at treatment decision))
- Psychological Distress(Instrument will be answered by the patient at approximately 1 week preoperative.)
- Psychological Distress(Instrument will be answered by the patient after surgery at 6 months postoperative.)
- Sickness absence/work(Instrument will be answered by the patient at baseline (at treatment decision).)
- Sickness absence/work(Instrument will be answered by the patient at approximately 1 week preoperative.)
- Sickness absence/work(Instrument will be answered by the patient after surgery at 6 months postoperative.)
- Physical activity(Single item question will be answered by the patient at baseline (at treatment decision).)
- Physical activity(Single item question will be answered by the patient at approximately 1 week preoperative.)
- Physical activity(Single item question will be answered by the patient after surgery at 6 months postoperative.)
- Alcohol use(Single item questions will be answered by the patient at baseline (at treatment decision).)
- Alcohol use(Single item questions will be answered by the patient at approximately 1 week preoperative.)
- Alcohol use(Single item questions will be answered by the patient after surgery at 6 months postoperative.)
- Tobacco use(Single item questions will be answered by the patient at baseline (at treatment decision).)
- Tobacco use(Single item questions will be answered by the patient at approximately 1 week preoperative.)
- Tobacco use(Single item questions will be answered by the patient after surgery at 6 months postoperative.)
- Weight(Single item question will be answered by the patient at baseline (at treatment decision).)
- Weight(Single item question will be answered by the patient at approximately 1 week preoperative.)
- Weight(Single item question will be answered by the patient after surgery at 6 months postoperative.)
- Body Mass Index (BMI)(Instrument will be answered by the patient after surgery at baseline (at treatment decision).)
- Body Mass Index (BMI)(Instrument will be answered by the patient at approximately 1 week preoperative.)
- Body Mass Index (BMI)(Instrument will be answered by the patient after surgery at 6 months postoperative.)
- Dysphagia(Instrument will be answered by the patient at baseline (at treatment decision).)
- Dysphagia(Instrument will be answered by the patient at approximately 1 week preoperative.)
- Dysphagia(Instrument will be answered by the patient after surgery at 6 months postoperative.)
- Rehabilitation process(Instrument will be answered by the patient at baseline (at treatment decision).)
- Rehabilitation process(Instrument will be answered by the patient at approximately 1 week preoperative.)
- Rehabilitation process(Instrument will be answered by the patient after surgery at 6 months postoperative.)
研究者
Marlene Malmström
Associate professor
Region Skane