Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer - a Clinical Trial Evaluating and Implementing a Model for Evidence-based Cancer Rehabilitation

Conditions
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Esophageal Cancer, Esophageal Neoplasms, Gastric Cancer, Stomach Neoplasm

Intervention / Treatment
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* Other: evidence-based individualized rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years of age esophageal or gastric cancer living in Southern Sweden (Skåne) are planned to undergo curative surgerytreatment at Skåne University Hospital. Exclusion Criteria: unable to communicate in the Swedish language suffering from a cognitive impairment that poses a barrier for participating in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental group<br>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) | Other: evidence-based individualized rehabilitation<br>* The experimental group will receive structured individualized assessment based on physical, psychological or social needs and will be offered evidence-based interventions to promote rehabilitation and recovery.<br>|
| Historical control group<br>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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Quality of life | 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. | Instrument will be answered by the patient at baseline (at treatment decision) | 
| General Quality of life | 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. | Instrument will be answered by the patient at approximately 1 week preoperative | 
| General Quality of life | 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. | Instrument will be answered by the patient after surgery at 6 months postoperative | 
| General Quality of life | 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. | Instrument will be answered by the patient after surgery at 12 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal and gastric cancer specific Quality of life | The instrument QLQ-OG25 is developed by the EORTC and measures diagnose specific quality of life. The instrument hast a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). The scoring approach for this instrument is identical in principle to that used for the scales/items of the EORTC-QLQ-C30. | Instrument will be answered by the patient at baseline (at treatment decision) | 
| Esophageal and gastric cancer specific Quality of life | The instrument QLQ-OG25 is developed by the EORTC and measures diagnose specific quality of life. The instrument hast a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). The scoring approach for this instrument is identical in principle to that used for the scales/items of the EORTC-QLQ-C30. | Instrument will be answered by the patient at approximately 1 week preoperative | 
| Esophageal and gastric cancer specific Quality of life | The instrument QLQ-OG25 is developed by the EORTC and measures diagnose specific quality of life. The instrument hast a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). The scoring approach for this instrument is identical in principle to that used for the scales/items of the EORTC-QLQ-C30. | Instrument will be answered by the patient after surgery at 6 months postoperative | 
| Esophageal and gastric cancer specific Quality of life | The instrument QLQ-OG25 is developed by the EORTC and measures diagnose specific quality of life. The instrument hast a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). The scoring approach for this instrument is identical in principle to that used for the scales/items of the EORTC-QLQ-C30. | Instrument will be answered by the patient after surgery at 12 months postoperative | 
| Information needs | The INFO-26 instrument is developed by the EORTC and measures the patients perception of information received. The response format is a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) in all items except four which has a two point scale (Yes/No). | Instrument will be answered by the patient at baseline (at treatment decision) | 
| Information needs | The INFO-26 instrument is developed by the EORTC and measures the patients perception of information received. The response format is a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) in all items except four which has a two point scale (Yes/No). | Instrument will be answered by the patient at approximately 1 week preoperative | 
| Information needs | The INFO-26 instrument is developed by the EORTC and measures the patients perception of information received. The response format is a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) in all items except four which has a two point scale (Yes/No). | Instrument will be answered by the patient after surgery at 6 months postoperative | 
| Information needs | The INFO-26 instrument is developed by the EORTC and measures the patients perception of information received. The response format is a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) in all items except four which has a two point scale (Yes/No). | Instrument will be answered by the patient after surgery at 12 months postoperative. | 
| International Physical Activity Questionnaire | The instrument IPAQ will be used to measure physical activity trough 5 questions on level of physical activity and time spent on physical activity. The IPAQ short form asks about three specific types of activities which are assessed in walking, moderate-intensity activities and vigorous-intensity activities. The instrument provides separate scores (duration and frequency) on the three types of activity. | Instrument will be answered by the patient at baseline (at treatment decision) | 
| International Physical Activity Questionnaire | The instrument IPAQ will be used to measure physical activity trough 5 questions on level of physical activity and time spent on physical activity. The IPAQ short form asks about three specific types of activities which are assessed in walking, moderate-intensity activities and vigorous-intensity activities. The instrument provides separate scores (duration and frequency) on the three types of activity. | Instrument will be answered by the patient at approximately 1 week preoperative | 
| International Physical Activity Questionnaire | The instrument IPAQ will be used to measure physical activity trough 5 questions on level of physical activity and time spent on physical activity. The IPAQ short form asks about three specific types of activities which are assessed in walking, moderate-intensity activities and vigorous-intensity activities. The instrument provides separate scores (duration and frequency) on the three types of activity. | Instrument will be answered by the patient after surgery at 6 months postoperative | 
| International Physical Activity Questionnaire | The instrument IPAQ will be used to measure physical activity trough 5 questions on level of physical activity and time spent on physical activity. The IPAQ short form asks about three specific types of activities which are assessed in walking, moderate-intensity activities and vigorous-intensity activities. The instrument provides separate scores (duration and frequency) on the three types of activity. | Instrument will be answered by the patient after surgery at 12 months postoperative | 
| Hospital Anxiety and Depression Scale | HADS will be used to measure the patients level of anxiety and depression. HADS is a 14-item scale with items for anxiety and depression subscales. Each item is rated on a 4-point Likert scale (ranging from 0=not at all, to 3=yes definitely) for a total score from 0-21 for each subscale. A higher score indicates higher levels of anxiety or depression. | Instrument will be answered by the patient at baseline (at treatment decision) | 
| Hospital Anxiety and Depression Scale | HADS will be used to measure the patients level of anxiety and depression. HADS is a 14-item scale with items for anxiety and depression subscales. Each item is rated on a 4-point Likert scale (ranging from 0=not at all, to 3=yes definitely) for a total score from 0-21 for each subscale. A higher score indicates higher levels of anxiety or depression. | Instrument will be answered by the patient at approximately 1 week preoperative | 
| Hospital Anxiety and Depression Scale | HADS will be used to measure the patients level of anxiety and depression. HADS is a 14-item scale with items for anxiety and depression subscales. Each item is rated on a 4-point Likert scale (ranging from 0=not at all, to 3=yes definitely) for a total score from 0-21 for each subscale. A higher score indicates higher levels of anxiety or depression. | Instrument will be answered by the patient after surgery at 6 months postoperative | 
| Hospital Anxiety and Depression Scale | HADS will be used to measure the patients level of anxiety and depression. HADS is a 14-item scale with items for anxiety and depression subscales. Each item is rated on a 4-point Likert scale (ranging from 0=not at all, to 3=yes definitely) for a total score from 0-21 for each subscale. A higher score indicates higher levels of anxiety or depression. | Instrument will be answered by the patient after surgery at 12 months postoperative | 
| Assessment of Survivorship Concerns | ASC will be used to measure the patients worry about cancer and worry about health trough 5 questions ranging from 1-4. Higher scores indicates greater worry. | Instrument will be answered by the patient at baseline (at treatment decision) | 
| Assessment of Survivorship Concerns | ASC will be used to measure the patients worry about cancer and worry about health trough 5 questions ranging from 1-4. Higher scores indicates greater worry. | Instrument will be answered by the patient at approximately 1 week preoperative | 
| Assessment of Survivorship Concerns | ASC will be used to measure the patients worry about cancer and worry about health trough 5 questions ranging from 1-4. Higher scores indicates greater worry. | Instrument will be answered by the patient after surgery at 6 months postoperative | 
| Assessment of Survivorship Concerns | ASC will be used to measure the patients worry about cancer and worry about health trough 5 questions ranging from 1-4. Higher scores indicates greater worry. | Instrument will be answered by the patient after surgery at 12 months postoperative | 
| Resilience | Connor-Davidsson Resilience Scale (CD-RISC) will be used to measure patients resilience trough 10 questions ranging from 0-4 Lower scores indicate more problems. | Instrument will be answered by the patient at baseline (at treatment decision) | 
| Resilience | Connor-Davidsson Resilience Scale (CD-RISC) will be used to measure patients resilience trough 10 questions ranging from 0-4 Lower scores indicate more problems. | Instrument will be answered by the patient at approximately 1 week preoperative | 
| Resilience | Connor-Davidsson Resilience Scale (CD-RISC) will be used to measure patients resilience trough 10 questions ranging from 0-4 Lower scores indicate more problems. | Instrument will be answered by the patientafter surgery at 6 months postoperative | 
| Resilience | Connor-Davidsson Resilience Scale (CD-RISC) will be used to measure patients resilience trough 10 questions ranging from 0-4 Lower scores indicate more problems. | Instrument will be answered by the patient after surgery at 12 months postoperative | 
| Assessment of rehabilitation needs. | Assessment of rehabilitation needs will be used to measure patients rehabilitation needs. A 4 point Likert scale which ranges from no problem to very troublesome problem . Higher scores indicate more problems. | Instrument will be answered by the patient at baseline (at treatment decision) | 
| Assessment of rehabilitation needs. | Higher scores indicate more problems. | Instrument will be answered by the patient at approximately 1 week preoperative | 
| Assessment of rehabilitation needs. | Higher scores indicate more problems. | Instrument will be answered by the patient after surgery at 6 months postoperative | 
| Assessment of rehabilitation needs. | Higher scores indicate more problems. | Instrument will be answered by the patient after surgery at 12 months postoperative | 
| Psychological Distress | Psychological Distress is measured by the Distress thermometer and will be used to measure level of distress. A scale from 0 = no distress to 10 = high distress. Higher scores indicate greater distress. | Instrument will be answered by the patient at baseline (at treatment decision) | 
| Psychological Distress | Psychological Distress is measured by the Distress thermometer and will be used to measure level of distress. A scale from 0 = no distress to 10 = high distress. Higher scores indicate greater distress. | Instrument will be answered by the patient at approximately 1 week preoperative. | 
| Psychological Distress | Psychological Distress is measured by the Distress thermometer and will be used to measure level of distress. A scale from 0 = no distress to 10 = high distress. Higher scores indicate greater distress. | Instrument will be answered by the patient after surgery at 6 months postoperative. | 
| Psychological Distress | Psychological Distress is measured by the Distress thermometer and will be used to measure level of distress. A scale from 0 = no distress to 10 = high distress. Higher scores indicate greater distress. | Instrument will be answered by the patient after surgery at 12 months postoperative. | 
| Sickness absence/work | Sickness abscens and to which extent the patient work will be measured by single items concerning this area. | Instrument will be answered by the patient at baseline (at treatment decision). | 
| Sickness absence/work | Sickness abscens and to which extent the patient work will be measured by single items concerning this area. | Instrument will be answered by the patient at approximately 1 week preoperative. | 
| Sickness absence/work | Sickness abscens and to which extent the patient work will be measured by single items concerning this area. | Instrument will be answered by the patient after surgery at 6 months postoperative. | 
| Sickness absence/work | Sickness abscens and to which extent the patient work will be measured by single items concerning this area. | Instrument will be answered by the patient after surgery at 12 months postoperative. | 
| Physical activity | Single item question concerning amount of hours physical activity per day. | Single item question will be answered by the patient at baseline (at treatment decision). | 
| Physical activity | Single item question concerning amount of hours physical activity per day. | Single item question will be answered by the patient at approximately 1 week preoperative. | 
| Physical activity | Single item question concerning amount of hours physical activity per day. | Single item question will be answered by the patient after surgery at 6 months postoperative. | 
| Physical activity | Single item question concerning amount of hours physical activity per day. | Single item question will be answered by the patient after surgery at 12 months postoperative. | 
| Alcohol use | Single item questions concerning alcohol use. | Single item questions will be answered by the patient at baseline (at treatment decision). | 
| Alcohol use | Single item questions concerning alcohol use. | Single item questions will be answered by the patient at approximately 1 week preoperative. | 
| Alcohol use | Single item questions concerning alcohol use. | Single item questions will be answered by the patient after surgery at 6 months postoperative. | 
| Alcohol use | Single item questions concerning alcohol use. | Single item questions will be answered by the patient after surgery at 12 months postoperative. | 
| Tobacco use | Single item questions concerning tobacco use. | Single item questions will be answered by the patient at baseline (at treatment decision). | 
| Tobacco use | Single item questions concerning tobacco use. | Single item questions will be answered by the patient at approximately 1 week preoperative. | 
| Tobacco use | Single item questions concerning tobacco use. | Single item questions will be answered by the patient after surgery at 6 months postoperative. | 
| Tobacco use | Single item questions concerning tobacco use. | Single item questions will be answered by the patient after surgery at 12 months postoperative. | 
| Height | Single item question concerning height in meters. | Single item question will be answered by the patient at baseline (at treatment decision). | 
| Weight | Single item question concerning weight in kilograms. | Single item question will be answered by the patient at baseline (at treatment decision). | 
| Weight | Single item question concerning weight in kilograms. | Single item question will be answered by the patient at approximately 1 week preoperative. | 
| Weight | Single item question concerning weight in kilograms. | Single item question will be answered by the patient after surgery at 6 months postoperative. | 
| Weight | Single item question concerning weight in kilograms. | Single item question will be answered by the patient after surgery at 12 months postoperative. | 
| Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m^2. | Instrument will be answered by the patient after surgery at baseline (at treatment decision). | 
| Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m^2. | Instrument will be answered by the patient at approximately 1 week preoperative. | 
| Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m^2. | Instrument will be answered by the patient after surgery at 6 months postoperative. | 
| Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m^2. | Instrument will be answered by the patient after surgery at 12 months postoperative. | 
| Dysphagia | Dysphagia will be measured by a single item concerning how it works to swallow for the patient and it ranges from 0-4 (0=no dysphagia to 4=total dysphagia) Higher scores indicate more difficulties swallowing. | Instrument will be answered by the patient at baseline (at treatment decision). | 
| Dysphagia | Dysphagia will be measured by a single item concerning how it works to swallow for the patient and it ranges from 0-4 (0=no dysphagia to 4=total dysphagia) Higher scores indicate more difficulties swallowing. | Instrument will be answered by the patient at approximately 1 week preoperative. | 
| Dysphagia | Dysphagia will be measured by a single item concerning how it works to swallow for the patient and it ranges from 0-4 (0=no dysphagia to 4=total dysphagia) Higher scores indicate more difficulties swallowing. | Instrument will be answered by the patient after surgery at 6 months postoperative. | 
| Dysphagia | Dysphagia will be measured by a single item concerning how it works to swallow for the patient and it ranges from 0-4 (0=no dysphagia to 4=total dysphagia) Higher scores indicate more difficulties swallowing. | Instrument will be answered by the patient after surgery at 12 months postoperative. | 
| Rehabilitation process | Questions about the rehabilitation process will be measured by single items concerning this area. | Instrument will be answered by the patient at baseline (at treatment decision). | 
| Rehabilitation process | Questions about the rehabilitation process will be measured by single items concerning this area. | Instrument will be answered by the patient at approximately 1 week preoperative. | 
| Rehabilitation process | Questions about the rehabilitation process will be measured by single items concerning this area. | Instrument will be answered by the patient after surgery at 6 months postoperative. | 
| Rehabilitation process | Questions about the rehabilitation process will be measured by single items concerning this area. | Instrument will be answered by the patient after surgery at 12 months postoperative. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer rehabilitation, Recovery