Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05698992

Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Skåne University Hospital

Lund, 222 42, Sweden

Location status: Recruiting

Location contact

Wenche Melander, PhD-student

CONTACT

[email protected]

+464171310

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

evidence-based individualized rehabilitation

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Esophageal and gastric cancer specific Quality of life

    Time frame: Instrument will be answered by the patient at baseline (at treatment decision)

    The instrument QLQ-OG25 is developed by the EORTC and measures diagnose specific quality of life. The instrument hast a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). The scoring approach for this instrument is identical in principle to that used for the scales/items of the EORTC-QLQ-C30.

  2. Esophageal and gastric cancer specific Quality of life

    Time frame: Instrument will be answered by the patient at approximately 1 week preoperative

    The instrument QLQ-OG25 is developed by the EORTC and measures diagnose specific quality of life. The instrument hast a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). The scoring approach for this instrument is identical in principle to that used for the scales/items of the EORTC-QLQ-C30.

  3. Esophageal and gastric cancer specific Quality of life

    Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative

    The instrument QLQ-OG25 is developed by the EORTC and measures diagnose specific quality of life. The instrument hast a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). The scoring approach for this instrument is identical in principle to that used for the scales/items of the EORTC-QLQ-C30.

  4. Esophageal and gastric cancer specific Quality of life

    Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative

    The instrument QLQ-OG25 is developed by the EORTC and measures diagnose specific quality of life. The instrument hast a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). The scoring approach for this instrument is identical in principle to that used for the scales/items of the EORTC-QLQ-C30.

  5. Information needs

    Time frame: Instrument will be answered by the patient at baseline (at treatment decision)

    The INFO-26 instrument is developed by the EORTC and measures the patients perception of information received. The response format is a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) in all items except four which has a two point scale (Yes/No).

  6. Information needs

    Time frame: Instrument will be answered by the patient at approximately 1 week preoperative

    The INFO-26 instrument is developed by the EORTC and measures the patients perception of information received. The response format is a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) in all items except four which has a two point scale (Yes/No).

  7. Information needs

    Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative

    The INFO-26 instrument is developed by the EORTC and measures the patients perception of information received. The response format is a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) in all items except four which has a two point scale (Yes/No).

  8. Information needs

    Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative.

    The INFO-26 instrument is developed by the EORTC and measures the patients perception of information received. The response format is a four-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) in all items except four which has a two point scale (Yes/No).

  9. International Physical Activity Questionnaire

    Time frame: Instrument will be answered by the patient at baseline (at treatment decision)

    The instrument IPAQ will be used to measure physical activity trough 5 questions on level of physical activity and time spent on physical activity. The IPAQ short form asks about three specific types of activities which are assessed in walking, moderate-intensity activities and vigorous-intensity activities. The instrument provides separate scores (duration and frequency) on the three types of activity.

  10. International Physical Activity Questionnaire

    Time frame: Instrument will be answered by the patient at approximately 1 week preoperative

    The instrument IPAQ will be used to measure physical activity trough 5 questions on level of physical activity and time spent on physical activity. The IPAQ short form asks about three specific types of activities which are assessed in walking, moderate-intensity activities and vigorous-intensity activities. The instrument provides separate scores (duration and frequency) on the three types of activity.

  11. International Physical Activity Questionnaire

    Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative

    The instrument IPAQ will be used to measure physical activity trough 5 questions on level of physical activity and time spent on physical activity. The IPAQ short form asks about three specific types of activities which are assessed in walking, moderate-intensity activities and vigorous-intensity activities. The instrument provides separate scores (duration and frequency) on the three types of activity.

  12. International Physical Activity Questionnaire

    Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative

    The instrument IPAQ will be used to measure physical activity trough 5 questions on level of physical activity and time spent on physical activity. The IPAQ short form asks about three specific types of activities which are assessed in walking, moderate-intensity activities and vigorous-intensity activities. The instrument provides separate scores (duration and frequency) on the three types of activity.

  13. Hospital Anxiety and Depression Scale

    Time frame: Instrument will be answered by the patient at baseline (at treatment decision)

    HADS will be used to measure the patients level of anxiety and depression. HADS is a 14-item scale with items for anxiety and depression subscales. Each item is rated on a 4-point Likert scale (ranging from 0=not at all, to 3=yes definitely) for a total score from 0-21 for each subscale. A higher score indicates higher levels of anxiety or depression.

  14. Hospital Anxiety and Depression Scale

    Time frame: Instrument will be answered by the patient at approximately 1 week preoperative

    HADS will be used to measure the patients level of anxiety and depression. HADS is a 14-item scale with items for anxiety and depression subscales. Each item is rated on a 4-point Likert scale (ranging from 0=not at all, to 3=yes definitely) for a total score from 0-21 for each subscale. A higher score indicates higher levels of anxiety or depression.

  15. Hospital Anxiety and Depression Scale

    Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative

    HADS will be used to measure the patients level of anxiety and depression. HADS is a 14-item scale with items for anxiety and depression subscales. Each item is rated on a 4-point Likert scale (ranging from 0=not at all, to 3=yes definitely) for a total score from 0-21 for each subscale. A higher score indicates higher levels of anxiety or depression.

  16. Hospital Anxiety and Depression Scale

    Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative

    HADS will be used to measure the patients level of anxiety and depression. HADS is a 14-item scale with items for anxiety and depression subscales. Each item is rated on a 4-point Likert scale (ranging from 0=not at all, to 3=yes definitely) for a total score from 0-21 for each subscale. A higher score indicates higher levels of anxiety or depression.

  17. Assessment of Survivorship Concerns

    Time frame: Instrument will be answered by the patient at baseline (at treatment decision)

    ASC will be used to measure the patients worry about cancer and worry about health trough 5 questions ranging from 1-4. Higher scores indicates greater worry.

  18. Assessment of Survivorship Concerns

    Time frame: Instrument will be answered by the patient at approximately 1 week preoperative

    ASC will be used to measure the patients worry about cancer and worry about health trough 5 questions ranging from 1-4. Higher scores indicates greater worry.

  19. Assessment of Survivorship Concerns

    Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative

    ASC will be used to measure the patients worry about cancer and worry about health trough 5 questions ranging from 1-4. Higher scores indicates greater worry.

  20. Assessment of Survivorship Concerns

    Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative

    ASC will be used to measure the patients worry about cancer and worry about health trough 5 questions ranging from 1-4. Higher scores indicates greater worry.

  21. Resilience

    Time frame: Instrument will be answered by the patient at baseline (at treatment decision)

    Connor-Davidsson Resilience Scale (CD-RISC) will be used to measure patients resilience trough 10 questions ranging from 0-4 Lower scores indicate more problems.

  22. Resilience

    Time frame: Instrument will be answered by the patient at approximately 1 week preoperative

    Connor-Davidsson Resilience Scale (CD-RISC) will be used to measure patients resilience trough 10 questions ranging from 0-4 Lower scores indicate more problems.

  23. Resilience

    Time frame: Instrument will be answered by the patientafter surgery at 6 months postoperative

    Connor-Davidsson Resilience Scale (CD-RISC) will be used to measure patients resilience trough 10 questions ranging from 0-4 Lower scores indicate more problems.

  24. Resilience

    Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative

    Connor-Davidsson Resilience Scale (CD-RISC) will be used to measure patients resilience trough 10 questions ranging from 0-4 Lower scores indicate more problems.

  25. Assessment of rehabilitation needs.

    Time frame: Instrument will be answered by the patient at baseline (at treatment decision)

    Assessment of rehabilitation needs will be used to measure patients rehabilitation needs. A 4 point Likert scale which ranges from "no problem" to "very troublesome problem" . Higher scores indicate more problems.

  26. Assessment of rehabilitation needs.

    Time frame: Instrument will be answered by the patient at approximately 1 week preoperative

    Higher scores indicate more problems.

  27. Assessment of rehabilitation needs.

    Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative

    Higher scores indicate more problems.

  28. Assessment of rehabilitation needs.

    Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative

    Higher scores indicate more problems.

  29. Psychological Distress

    Time frame: Instrument will be answered by the patient at baseline (at treatment decision)

    Psychological Distress is measured by the "Distress thermometer" and will be used to measure level of distress. A scale from 0 = no distress to 10 = high distress. Higher scores indicate greater distress.

  30. Psychological Distress

    Time frame: Instrument will be answered by the patient at approximately 1 week preoperative.

    Psychological Distress is measured by the "Distress thermometer" and will be used to measure level of distress. A scale from 0 = no distress to 10 = high distress. Higher scores indicate greater distress.

  31. Psychological Distress

    Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative.

    Psychological Distress is measured by the "Distress thermometer" and will be used to measure level of distress. A scale from 0 = no distress to 10 = high distress. Higher scores indicate greater distress.

  32. Psychological Distress

    Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative.

    Psychological Distress is measured by the "Distress thermometer" and will be used to measure level of distress. A scale from 0 = no distress to 10 = high distress. Higher scores indicate greater distress.

  33. Sickness absence/work

    Time frame: Instrument will be answered by the patient at baseline (at treatment decision).

    Sickness abscens and to which extent the patient work will be measured by single items concerning this area.

  34. Sickness absence/work

    Time frame: Instrument will be answered by the patient at approximately 1 week preoperative.

    Sickness abscens and to which extent the patient work will be measured by single items concerning this area.

  35. Sickness absence/work

    Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative.

    Sickness abscens and to which extent the patient work will be measured by single items concerning this area.

  36. Sickness absence/work

    Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative.

    Sickness abscens and to which extent the patient work will be measured by single items concerning this area.

  37. Physical activity

    Time frame: Single item question will be answered by the patient at baseline (at treatment decision).

    Single item question concerning amount of hours physical activity per day.

  38. Physical activity

    Time frame: Single item question will be answered by the patient at approximately 1 week preoperative.

    Single item question concerning amount of hours physical activity per day.

  39. Physical activity

    Time frame: Single item question will be answered by the patient after surgery at 6 months postoperative.

    Single item question concerning amount of hours physical activity per day.

  40. Physical activity

    Time frame: Single item question will be answered by the patient after surgery at 12 months postoperative.

    Single item question concerning amount of hours physical activity per day.

  41. Alcohol use

    Time frame: Single item questions will be answered by the patient at baseline (at treatment decision).

    Single item questions concerning alcohol use.

  42. Alcohol use

    Time frame: Single item questions will be answered by the patient at approximately 1 week preoperative.

    Single item questions concerning alcohol use.

  43. Alcohol use

    Time frame: Single item questions will be answered by the patient after surgery at 6 months postoperative.

    Single item questions concerning alcohol use.

  44. Alcohol use

    Time frame: Single item questions will be answered by the patient after surgery at 12 months postoperative.

    Single item questions concerning alcohol use.

  45. Tobacco use

    Time frame: Single item questions will be answered by the patient at baseline (at treatment decision).

    Single item questions concerning tobacco use.

  46. Tobacco use

    Time frame: Single item questions will be answered by the patient at approximately 1 week preoperative.

    Single item questions concerning tobacco use.

  47. Tobacco use

    Time frame: Single item questions will be answered by the patient after surgery at 6 months postoperative.

    Single item questions concerning tobacco use.

  48. Tobacco use

    Time frame: Single item questions will be answered by the patient after surgery at 12 months postoperative.

    Single item questions concerning tobacco use.

  49. Height

    Time frame: Single item question will be answered by the patient at baseline (at treatment decision).

    Single item question concerning height in meters.

  50. Weight

    Time frame: Single item question will be answered by the patient at baseline (at treatment decision).

    Single item question concerning weight in kilograms.

  51. Weight

    Time frame: Single item question will be answered by the patient at approximately 1 week preoperative.

    Single item question concerning weight in kilograms.

  52. Weight

    Time frame: Single item question will be answered by the patient after surgery at 6 months postoperative.

    Single item question concerning weight in kilograms.

  53. Weight

    Time frame: Single item question will be answered by the patient after surgery at 12 months postoperative.

    Single item question concerning weight in kilograms.

  54. Body Mass Index (BMI)

    Time frame: Instrument will be answered by the patient after surgery at baseline (at treatment decision).

    Weight and height will be combined to report BMI in kg/m^2.

  55. Body Mass Index (BMI)

    Time frame: Instrument will be answered by the patient at approximately 1 week preoperative.

    Weight and height will be combined to report BMI in kg/m^2.

  56. Body Mass Index (BMI)

    Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative.

    Weight and height will be combined to report BMI in kg/m^2.

  57. Body Mass Index (BMI)

    Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative.

    Weight and height will be combined to report BMI in kg/m^2.

  58. Dysphagia

    Time frame: Instrument will be answered by the patient at baseline (at treatment decision).

    Dysphagia will be measured by a single item concerning how it works to swallow for the patient and it ranges from 0-4 (0=no dysphagia to 4=total dysphagia) Higher scores indicate more difficulties swallowing.

  59. Dysphagia

    Time frame: Instrument will be answered by the patient at approximately 1 week preoperative.

    Dysphagia will be measured by a single item concerning how it works to swallow for the patient and it ranges from 0-4 (0=no dysphagia to 4=total dysphagia) Higher scores indicate more difficulties swallowing.

  60. Dysphagia

    Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative.

    Dysphagia will be measured by a single item concerning how it works to swallow for the patient and it ranges from 0-4 (0=no dysphagia to 4=total dysphagia) Higher scores indicate more difficulties swallowing.

  61. Dysphagia

    Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative.

    Dysphagia will be measured by a single item concerning how it works to swallow for the patient and it ranges from 0-4 (0=no dysphagia to 4=total dysphagia) Higher scores indicate more difficulties swallowing.

  62. Rehabilitation process

    Time frame: Instrument will be answered by the patient at baseline (at treatment decision).

    Questions about the rehabilitation process will be measured by single items concerning this area.

  63. Rehabilitation process

    Time frame: Instrument will be answered by the patient at approximately 1 week preoperative.

    Questions about the rehabilitation process will be measured by single items concerning this area.

  64. Rehabilitation process

    Time frame: Instrument will be answered by the patient after surgery at 6 months postoperative.

    Questions about the rehabilitation process will be measured by single items concerning this area.

  65. Rehabilitation process

    Time frame: Instrument will be answered by the patient after surgery at 12 months postoperative.

    Questions about the rehabilitation process will be measured by single items concerning this area.

Other outcomes

  1. Demographics

    Time frame: The data will be collected 12 months after surgery.

    Demographic details will be collected from participants via NREV (Swedish national quality registry for esophageal and gastric cancer). There are no scales, only quality registry data.This data includes gender,cancerdiagnosis, tumourstage, comorbidity according to ASA, surgerydate, postoperative tumourstage.

  2. Overall survival

    Time frame: Up to 1 year after surgery

    Overall survival will be collected from participants via NREV (Swedish national quality registry for esophageal and gastric cancer). There are no scales, only quality registry data.

  3. Incidence and severity of general complications

    Time frame: Up to 30 days postoperative

    Incidence rate and severity of general complication according to Clavien-Dindo classification. Genereal complications will be collected from participants via NREV (Swedish national quality registry for esophageal and gastric cancer).

  4. Change of level of care

    Time frame: Up to 30 days postoperative

    Incidence rate of change of level of care in the context of postoperative care will be collected from participants via NREV (Swedish national quality registry for esophageal and gastric cancer).

  5. Length of stay

    Time frame: from the day before surgery to discharge from the hospital

    Length of stay at the hospital will be collected from participants via NREV (Swedish national quality registry for esophageal and gastric cancer). Will be measured in number of days.

  6. Rate of re-admission

    Time frame: Up to 30 days postoperative

    The rate of re-admission up to 30 days postoperative will be collected via NREV (Swedish national quality registry for esophageal and gastric cancer).

  7. Discharge destination

    Time frame: The data will be collected 12 months postoperative

    Postoperative discharge destination (i.e if the patients goes home or to another care unit after discharge) will be collected via NREV (Swedish national quality registry for esophageal and gastric cancer)

Study contacts

Contact information is provided by the study sponsor or research team.

Marlene Malmström, PhD

CONTACT

marlene.malmströ[email protected]

+4646175950

Wenche Melander, PhD-student

CONTACT

[email protected]

+4646171310

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.