Rehabilitation and Recovery for Persons with Esophageal or Gastric Cancer
1 other identifier
observational
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2022
CompletedFirst Posted
Study publicly available on registry
January 26, 2023
CompletedStudy Start
First participant enrolled
February 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
November 19, 2024
November 1, 2024
3.8 years
December 2, 2022
November 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (65)
Esophageal and gastric cancer specific Quality of life
Instrument will be answered by the patient at baseline (at treatment decision)
Esophageal and gastric cancer specific Quality of life
Instrument will be answered by the patient at approximately 1 week preoperative
Esophageal and gastric cancer specific Quality of life
Instrument will be answered by the patient after surgery at 6 months postoperative
Esophageal and gastric cancer specific Quality of life
Instrument will be answered by the patient after surgery at 12 months postoperative
Information needs
Instrument will be answered by the patient at baseline (at treatment decision)
- +60 more secondary outcomes
Other Outcomes (7)
Demographics
The data will be collected 12 months after surgery.
Overall survival
Up to 1 year after surgery
Incidence and severity of general complications
Up to 30 days postoperative
- +4 more other outcomes
Study Arms (2)
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)
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)
Interventions
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.
Eligibility Criteria
\*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.
You may qualify if:
- over 18 years of age
- esophageal or gastric cancer
- living in Southern Sweden (Skåne)
- are planned to undergo curative surgerytreatment at Skåne University Hospital.
You may not qualify if:
- unable to communicate in the Swedish language
- suffering from a cognitive impairment that poses a barrier for participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
- Karolinska Institutetcollaborator
Study Sites (1)
Skåne University Hospital
Lund, Lund, 222 42, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 15 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
December 2, 2022
First Posted
January 26, 2023
Study Start
February 27, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
November 19, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share