Esophageal CancerNCT05698992
Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer
An observational study of Esophageal Cancer and Esophageal Neoplasms, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Esophageal Neoplasms, Gastric Cancer
- What is being tested?
- evidence-based individualized rehabilitation
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 27 Feb 2023to 31 Dec 2027
- How long will I take part?
- 15 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- over 18 years of age
- esophageal or gastric cancer
- living in Southern Sweden (Skåne)
- are planned to undergo curative surgerytreatment at Skåne University Hospital.
Who cannot join
- unable to communicate in the Swedish language
- suffering from a cognitive impairment that poses a barrier for participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital
Lund, Lund, 222 42
Wenche Melander, PhD-student, +464171310, wenche.melander@skane.se
About this study
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
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.
Read the 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.
- Being tested
- evidence-based individualized rehabilitation
- Keywords
- Cancer rehabilitation, Recovery
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evidence-based individualized rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: evidence-based individualized rehabilitation | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Instrument will be answered by the patient after surgery at 12 months postoperative
Secondary outcomes (65)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Instrument will be answered by the patient at baseline (at treatment decision)
Assessment of rehabilitation needs.
Higher scores indicate more problems.
Measured: Instrument will be answered by the patient at approximately 1 week preoperative
Assessment of rehabilitation needs.
Higher scores indicate more problems.
Measured: Instrument will be answered by the patient after surgery at 6 months postoperative
Assessment of rehabilitation needs.
Higher scores indicate more problems.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Single item question will be answered by the patient after surgery at 12 months postoperative.
Alcohol use
Single item questions concerning alcohol use.
Measured: Single item questions will be answered by the patient at baseline (at treatment decision).
Alcohol use
Single item questions concerning alcohol use.
Measured: Single item questions will be answered by the patient at approximately 1 week preoperative.
Alcohol use
Single item questions concerning alcohol use.
Measured: Single item questions will be answered by the patient after surgery at 6 months postoperative.
Alcohol use
Single item questions concerning alcohol use.
Measured: Single item questions will be answered by the patient after surgery at 12 months postoperative.
Tobacco use
Single item questions concerning tobacco use.
Measured: Single item questions will be answered by the patient at baseline (at treatment decision).
Tobacco use
Single item questions concerning tobacco use.
Measured: Single item questions will be answered by the patient at approximately 1 week preoperative.
Tobacco use
Single item questions concerning tobacco use.
Measured: Single item questions will be answered by the patient after surgery at 6 months postoperative.
Tobacco use
Single item questions concerning tobacco use.
Measured: Single item questions will be answered by the patient after surgery at 12 months postoperative.
Height
Single item question concerning height in meters.
Measured: Single item question will be answered by the patient at baseline (at treatment decision).
Weight
Single item question concerning weight in kilograms.
Measured: Single item question will be answered by the patient at baseline (at treatment decision).
Weight
Single item question concerning weight in kilograms.
Measured: Single item question will be answered by the patient at approximately 1 week preoperative.
Weight
Single item question concerning weight in kilograms.
Measured: Single item question will be answered by the patient after surgery at 6 months postoperative.
Weight
Single item question concerning weight in kilograms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Instrument will be answered by the patient after surgery at 12 months postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start27 Feb 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Marlene Malmström, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698992
- Sponsor's protocol ID
- Esophageal/gastric cancerrehab
- Status last verified
- May 2026
- First submitted
- 2 Dec 2022
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05698992
- Acronym / sponsor ID
- Esophageal/gastric cancerrehab
- Keywords
- Cancer rehabilitation, Recovery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop and evaluate a model for systematic and evidence-based cancer rehabilitation for people with esophageal and gastric cancer to provide conditions for a better quality of life and fewer cancer-related symptoms.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: evidence-based individualized rehabilitationPatients 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) |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- over 18 years of age
- esophageal or gastric cancer
- living in Southern Sweden (Skåne)
- are planned to undergo curative surgerytreatment at Skåne University Hospital.
Key exclusion criteria (2 listed)
- unable to communicate in the Swedish language
- suffering from a cognitive impairment that poses a barrier for participating in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evidence-based individualized rehabilitationThe 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. | Other | Experimental group |
Primary outcome
General Quality of life
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.
General Quality of life
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.
General Quality of life
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.
General Quality of life
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.
65 secondary outcomes
Esophageal and gastric cancer specific Quality of life
Time frame: Instrument will be answered by the patient at baseline (at treatment decision)
Esophageal and gastric cancer specific Quality of life
Time frame: Instrument will be answered by the patient at approximately 1 week preoperative
Esophageal and gastric cancer specific Quality of life
Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative
Esophageal and gastric cancer specific Quality of life
Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative
Information needs
Time frame: Instrument will be answered by the patient at baseline (at treatment decision)
Information needs
Time frame: Instrument will be answered by the patient at approximately 1 week preoperative
Information needs
Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative
Information needs
Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative.
International Physical Activity Questionnaire
Time frame: Instrument will be answered by the patient at baseline (at treatment decision)
International Physical Activity Questionnaire
Time frame: Instrument will be answered by the patient at approximately 1 week preoperative
International Physical Activity Questionnaire
Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative
International Physical Activity Questionnaire
Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative
Hospital Anxiety and Depression Scale
Time frame: Instrument will be answered by the patient at baseline (at treatment decision)
Hospital Anxiety and Depression Scale
Time frame: Instrument will be answered by the patient at approximately 1 week preoperative
Hospital Anxiety and Depression Scale
Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative
Hospital Anxiety and Depression Scale
Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative
Assessment of Survivorship Concerns
Time frame: Instrument will be answered by the patient at baseline (at treatment decision)
Assessment of Survivorship Concerns
Time frame: Instrument will be answered by the patient at approximately 1 week preoperative
Assessment of Survivorship Concerns
Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative
Assessment of Survivorship Concerns
Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative
Resilience
Time frame: Instrument will be answered by the patient at baseline (at treatment decision)
Resilience
Time frame: Instrument will be answered by the patient at approximately 1 week preoperative
Resilience
Time frame: Instrument will be answered by the patientafter surgery at 6 months postoperative
Resilience
Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative
Assessment of rehabilitation needs.
Time frame: Instrument will be answered by the patient at baseline (at treatment decision)
Assessment of rehabilitation needs.
Time frame: Instrument will be answered by the patient at approximately 1 week preoperative
Assessment of rehabilitation needs.
Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative
Assessment of rehabilitation needs.
Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative
Psychological Distress
Time frame: Instrument will be answered by the patient at baseline (at treatment decision)
Psychological Distress
Time frame: Instrument will be answered by the patient at approximately 1 week preoperative.
Psychological Distress
Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative.
Psychological Distress
Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative.
Sickness absence/work
Time frame: Instrument will be answered by the patient at baseline (at treatment decision).
Sickness absence/work
Time frame: Instrument will be answered by the patient at approximately 1 week preoperative.
Sickness absence/work
Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative.
Sickness absence/work
Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative.
Physical activity
Time frame: Single item question will be answered by the patient at baseline (at treatment decision).
Physical activity
Time frame: Single item question will be answered by the patient at approximately 1 week preoperative.
Physical activity
Time frame: Single item question will be answered by the patient after surgery at 6 months postoperative.
Physical activity
Time frame: Single item question will be answered by the patient after surgery at 12 months postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Esophageal Neoplasms, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenche Melander, PhD-student (+4646171310, wenche.melander@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Quality of life (time frame: Instrument will be answered by the patient at baseline (at treatment decision)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.