Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer

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

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 Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Esophageal Cancer; Esophageal Neoplasms; Stomach Neoplasm
• Intervention / Treatment: Other: evidence-based individualized rehabilitation

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Marlene Malmström, PhD; Phone Number: +4646175950; Email: marlene.malmström@skane.se
• Study Contact Backup: Name: Wenche Melander, PhD-student; Phone Number: +4646171310; Email: wenche.melander@skane.se

Study Locations

• Sweden
  • Lund
    • Lund, Lund, Sweden, 222 42
      • Recruiting
      • Skåne University Hospital
      • Contact: Wenche Melander, PhD-student; Phone Number: +464171310; Email: wenche.melander@skane.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

*patients over 18 years of age with esophageal or gastric cancer, who are living in Southern Sweden (Skåne), and are planned to undergo or has undergone curative surgerytreatment at Skåne University Hospital.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental group; Patients over 18 years of age with esophageal or gastric cancer, who are living in Southern Sweden, and who are planned to undergo curative surgery treatment at Skåne University Hospital. n=100 (anticipated)	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.
Historical control group; The historical control group consists of patients, living in Southern Sweden, who underwent esophageal or gastric cancer surgery between 2013 - 2021 at Skåne University Hospital. n=100 (anticipated)

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Recovery; Cancer rehabilitation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Neoplasms; Esophageal Neoplasms
• Other Study ID Numbers: Esophageal/gastric cancerrehab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No