Skåne University Hospital
Lund, 222 42, Sweden
Location status: Recruiting
NCT Number: NCT05698992
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Lund, 222 42, Sweden
Location status: Recruiting
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Instrument will be answered by the patient at baseline (at treatment decision)
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
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
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
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)
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
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
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.
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)
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
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
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
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)
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
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
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
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)
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
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
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
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)
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
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
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
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)
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 approximately 1 week preoperative
Higher scores indicate more problems.
Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative
Higher scores indicate more problems.
Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative
Higher scores indicate more problems.
Time frame: Instrument will be answered by the patient at baseline (at treatment decision)
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 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 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.
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).
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 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 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.
Sickness abscens and to which extent the patient work will be measured by single items concerning this area.
Time frame: Single item question will be answered by the patient at baseline (at treatment decision).
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.
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.
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.
Single item question concerning amount of hours physical activity per day.
Time frame: Single item questions will be answered by the patient at baseline (at treatment decision).
Single item questions concerning alcohol use.
Time frame: Single item questions will be answered by the patient at approximately 1 week preoperative.
Single item questions concerning alcohol use.
Time frame: Single item questions will be answered by the patient after surgery at 6 months postoperative.
Single item questions concerning alcohol use.
Time frame: Single item questions will be answered by the patient after surgery at 12 months postoperative.
Single item questions concerning alcohol use.
Time frame: Single item questions will be answered by the patient at baseline (at treatment decision).
Single item questions concerning tobacco use.
Time frame: Single item questions will be answered by the patient at approximately 1 week preoperative.
Single item questions concerning tobacco use.
Time frame: Single item questions will be answered by the patient after surgery at 6 months postoperative.
Single item questions concerning tobacco use.
Time frame: Single item questions will be answered by the patient after surgery at 12 months postoperative.
Single item questions concerning tobacco use.
Time frame: Single item question will be answered by the patient at baseline (at treatment decision).
Single item question concerning height in meters.
Time frame: Single item question will be answered by the patient at baseline (at treatment decision).
Single item question concerning weight in kilograms.
Time frame: Single item question will be answered by the patient at approximately 1 week preoperative.
Single item question concerning weight in kilograms.
Time frame: Single item question will be answered by the patient after surgery at 6 months postoperative.
Single item question concerning weight in kilograms.
Time frame: Single item question will be answered by the patient after surgery at 12 months postoperative.
Single item question concerning weight in kilograms.
Time frame: Instrument will be answered by the patient after surgery at baseline (at treatment decision).
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.
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.
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.
Weight and height will be combined to report BMI in kg/m^2.
Time frame: Instrument will be answered by the patient at baseline (at treatment decision).
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 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 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.
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).
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.
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.
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.
Questions about the rehabilitation process will be measured by single items concerning this area.
Time frame: The data will be collected 12 months after surgery.
Demographic details will be collected from participants via NREV (Swedish national quality registry for esophageal and gastric cancer). There are no scales, only quality registry data.This data includes gender,cancerdiagnosis, tumourstage, comorbidity according to ASA, surgerydate, postoperative tumourstage.
Time frame: Up to 1 year after surgery
Overall survival will be collected from participants via NREV (Swedish national quality registry for esophageal and gastric cancer). There are no scales, only quality registry data.
Time frame: Up to 30 days postoperative
Incidence rate and severity of general complication according to Clavien-Dindo classification. Genereal complications will be collected from participants via NREV (Swedish national quality registry for esophageal and gastric cancer).
Time frame: Up to 30 days postoperative
Incidence rate of change of level of care in the context of postoperative care will be collected from participants via NREV (Swedish national quality registry for esophageal and gastric cancer).
Time frame: from the day before surgery to discharge from the hospital
Length of stay at the hospital will be collected from participants via NREV (Swedish national quality registry for esophageal and gastric cancer). Will be measured in number of days.
Time frame: Up to 30 days postoperative
The rate of re-admission up to 30 days postoperative will be collected via NREV (Swedish national quality registry for esophageal and gastric cancer).
Time frame: The data will be collected 12 months postoperative
Postoperative discharge destination (i.e if the patients goes home or to another care unit after discharge) will be collected via NREV (Swedish national quality registry for esophageal and gastric cancer)
Contact information is provided by the study sponsor or research team.
Marlene Malmström, PhD
CONTACT
marlene.malmströ[email protected]
Wenche Melander, PhD-student
CONTACT
Region Skane
Other
Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer - a Clinical Trial Evaluating and Implementing a Model for Evidence-based Cancer Rehabilitation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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