Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698992
• Other study ID #: Esophageal/gastric cancerrehab
• Status: Recruiting
• Start date: February 27, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2023
• Source: Region Skane
• Contact: Wenche Melander, PhD-student
• Phone: +4646171310
• Email: wenche.melander[@]skane.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Neoplasms
• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Other:
• evidence-based individualized rehabilitation
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.

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	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.	The data will be collected 12 months after surgery.
Other	Overall survival	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.	Up to 1 year after surgery
Other	Incidence and severity of general complications	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).	Up to 30 days postoperative
Other	Change of level of care	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).	Up to 30 days postoperative
Other	Length of stay	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.	from the day before surgery to discharge from the hospital
Other	Rate of re-admission	The rate of re-admission up to 30 days postoperative will be collected via NREV (Swedish national quality registry for esophageal and gastric cancer).	Up to 30 days postoperative
Other	Discharge destination	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)	The data will be collected 12 months postoperative
Primary	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)
Primary	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
Primary	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
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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.
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	Assessment of rehabilitation needs.	Higher scores indicate more problems.	Instrument will be answered by the patient at approximately 1 week preoperative
Secondary	Assessment of rehabilitation needs.	Higher scores indicate more problems.	Instrument will be answered by the patient after surgery at 6 months postoperative
Secondary	Assessment of rehabilitation needs.	Higher scores indicate more problems.	Instrument will be answered by the patient after surgery at 12 months postoperative
Secondary	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)
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Alcohol use	Single item questions concerning alcohol use.	Single item questions will be answered by the patient at baseline (at treatment decision).
Secondary	Alcohol use	Single item questions concerning alcohol use.	Single item questions will be answered by the patient at approximately 1 week preoperative.
Secondary	Alcohol use	Single item questions concerning alcohol use.	Single item questions will be answered by the patient after surgery at 6 months postoperative.
Secondary	Alcohol use	Single item questions concerning alcohol use.	Single item questions will be answered by the patient after surgery at 12 months postoperative.
Secondary	Tobacco use	Single item questions concerning tobacco use.	Single item questions will be answered by the patient at baseline (at treatment decision).
Secondary	Tobacco use	Single item questions concerning tobacco use.	Single item questions will be answered by the patient at approximately 1 week preoperative.
Secondary	Tobacco use	Single item questions concerning tobacco use.	Single item questions will be answered by the patient after surgery at 6 months postoperative.
Secondary	Tobacco use	Single item questions concerning tobacco use.	Single item questions will be answered by the patient after surgery at 12 months postoperative.
Secondary	Height	Single item question concerning height in meters.	Single item question will be answered by the patient at baseline (at treatment decision).
Secondary	Weight	Single item question concerning weight in kilograms.	Single item question will be answered by the patient at baseline (at treatment decision).
Secondary	Weight	Single item question concerning weight in kilograms.	Single item question will be answered by the patient at approximately 1 week preoperative.
Secondary	Weight	Single item question concerning weight in kilograms.	Single item question will be answered by the patient after surgery at 6 months postoperative.
Secondary	Weight	Single item question concerning weight in kilograms.	Single item question will be answered by the patient after surgery at 12 months postoperative.
Secondary	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).
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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.
Secondary	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.
Secondary	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.