Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
over 18 years of age
esophageal or gastric cancer
living in Southern Sweden (Skåne)
are planned to undergo curative surgerytreatment at Skåne University Hospital.
Disqualifiers
unable to communicate in the Swedish language
suffering from a cognitive impairment that poses a barrier for participating in the study.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
evidence-based individualized rehabilitation
Other interventionThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Experimental group1 intervention
Group B: Historical control group0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Instrument will be answered by the patient at baseline (at treatment decision)2
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.
Time frame
Instrument will be answered by the patient at approximately 1 week preoperative3
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.
Time frame
Instrument will be answered by the patient after surgery at 6 months postoperative4
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.
Time frame
Instrument will be answered by the patient after surgery at 12 months postoperativeSecondary outcomes
1
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.
Time frame
Instrument will be answered by the patient at baseline (at treatment decision)2
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.
Time frame
Instrument will be answered by the patient at approximately 1 week preoperative3
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.
Time frame
Instrument will be answered by the patient after surgery at 6 months postoperative4
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.
Time frame
Instrument will be answered by the patient after surgery at 12 months postoperativeOther outcomes
1
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.
Time frame
The data will be collected 12 months after surgery.2
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.
Time frame
Up to 1 year after surgery3
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).
Time frame
Up to 30 days postoperative4
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).
Time frame
Up to 30 days postoperativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Skane
Lead sponsor
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov