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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
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.
Skåne University Hospital
Lund, Lund, Sweden
RECRUITINGGeneral 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: Instrument will be answered by the patient after surgery at 12 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Instrument will be answered by the patient at baseline (at treatment decision)
Assessment of rehabilitation needs.
Higher scores indicate more problems.
Time frame: Instrument will be answered by the patient at approximately 1 week preoperative
Assessment of rehabilitation needs.
Higher scores indicate more problems.
Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative
Assessment of rehabilitation needs.
Higher scores indicate more problems.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Single item question will be answered by the patient after surgery at 12 months postoperative.
Alcohol use
Single item questions concerning alcohol use.
Time frame: Single item questions will be answered by the patient at baseline (at treatment decision).
Alcohol use
Single item questions concerning alcohol use.
Time frame: Single item questions will be answered by the patient at approximately 1 week preoperative.
Alcohol use
Single item questions concerning alcohol use.
Time frame: Single item questions will be answered by the patient after surgery at 6 months postoperative.
Alcohol use
Single item questions concerning alcohol use.
Time frame: Single item questions will be answered by the patient after surgery at 12 months postoperative.
Tobacco use
Single item questions concerning tobacco use.
Time frame: Single item questions will be answered by the patient at baseline (at treatment decision).
Tobacco use
Single item questions concerning tobacco use.
Time frame: Single item questions will be answered by the patient at approximately 1 week preoperative.
Tobacco use
Single item questions concerning tobacco use.
Time frame: Single item questions will be answered by the patient after surgery at 6 months postoperative.
Tobacco use
Single item questions concerning tobacco use.
Time frame: Single item questions will be answered by the patient after surgery at 12 months postoperative.
Height
Single item question concerning height in meters.
Time frame: Single item question will be answered by the patient at baseline (at treatment decision).
Weight
Single item question concerning weight in kilograms.
Time frame: Single item question will be answered by the patient at baseline (at treatment decision).
Weight
Single item question concerning weight in kilograms.
Time frame: Single item question will be answered by the patient at approximately 1 week preoperative.
Weight
Single item question concerning weight in kilograms.
Time frame: Single item question will be answered by the patient after surgery at 6 months postoperative.
Weight
Single item question concerning weight in kilograms.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative.