Clinical trial NCT05698992: Rehabilitation and Recovery for Persons with Esophageal or Gastric Cancer
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Cancer
Esophageal Neoplasms
Gastric Cancer
Stomach Neoplasm
Keywords: Cancer rehabilitation
Recovery
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2023-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: General Quality of life
timeFrame: Instrument will be answered by the patient at baseline (at treatment decision)
measure: General Quality of life
timeFrame: Instrument will be answered by the patient at approximately 1 week preoperative
measure: General Quality of life
timeFrame: Instrument will be answered by the patient after surgery at 6 months postoperative
measure: General Quality of life
timeFrame: Instrument will be answered by the patient after surgery at 12 months postoperative
Secondary outcomes:
measure: Esophageal and gastric cancer specific Quality of life
timeFrame: Instrument will be answered by the patient at baseline (at treatment decision)
measure: Esophageal and gastric cancer specific Quality of life
timeFrame: Instrument will be answered by the patient at approximately 1 week preoperative
measure: Esophageal and gastric cancer specific Quality of life
timeFrame: Instrument will be answered by the patient after surgery at 6 months postoperative
measure: Esophageal and gastric cancer specific Quality of life
timeFrame: Instrument will be answered by the patient after surgery at 12 months postoperative
measure: Information needs
timeFrame: Instrument will be answered by the patient at baseline (at treatment decision)
measure: Information needs
timeFrame: Instrument will be answered by the patient at approximately 1 week preoperative
measure: Information needs
timeFrame: Instrument will be answered by the patient after surgery at 6 months postoperative
measure: Information needs
timeFrame: Instrument will be answered by the patient after surgery at 12 months postoperative.
measure: International Physical Activity Questionnaire
timeFrame: Instrument will be answered by the patient at baseline (at treatment decision)
measure: International Physical Activity Questionnaire
timeFrame: Instrument will be answered by the patient at approximately 1 week preoperative
measure: International Physical Activity Questionnaire
timeFrame: Instrument will be answered by the patient after surgery at 6 months postoperative
measure: International Physical Activity Questionnaire
timeFrame: Instrument will be answered by the patient after surgery at 12 months postoperative
measure: Hospital Anxiety and Depression Scale
timeFrame: Instrument will be answered by the patient at baseline (at treatment decision)
measure: Hospital Anxiety and Depression Scale
timeFrame: Instrument will be answered by the patient at approximately 1 week preoperative
measure: Hospital Anxiety and Depression Scale
timeFrame: Instrument will be answered by the patient after surgery at 6 months postoperative
measure: Hospital Anxiety and Depression Scale
timeFrame: Instrument will be answered by the patient after surgery at 12 months postoperative
measure: Assessment of Survivorship Concerns
timeFrame: Instrument will be answered by the patient at baseline (at treatment decision)
measure: Assessment of Survivorship Concerns
timeFrame: Instrument will be answered by the patient at approximately 1 week preoperative
measure: Assessment of Survivorship Concerns
timeFrame: Instrument will be answered by the patient after surgery at 6 months postoperative
measure: Assessment of Survivorship Concerns
timeFrame: Instrument will be answered by the patient after surgery at 12 months postoperative
measure: Resilience
timeFrame: Instrument will be answered by the patient at baseline (at treatment decision)
measure: Resilience
timeFrame: Instrument will be answered by the patient at approximately 1 week preoperative
measure: Resilience
timeFrame: Instrument will be answered by the patientafter surgery at 6 months postoperative
measure: Resilience
timeFrame: Instrument will be answered by the patient after surgery at 12 months postoperative
measure: Assessment of rehabilitation needs.
timeFrame: Instrument will be answered by the patient at baseline (at treatment decision)
measure: Assessment of rehabilitation needs.
timeFrame: Instrument will be answered by the patient at approximately 1 week preoperative
measure: Assessment of rehabilitation needs.
timeFrame: Instrument will be answered by the patient after surgery at 6 months postoperative
measure: Assessment of rehabilitation needs.
timeFrame: Instrument will be answered by the patient after surgery at 12 months postoperative
measure: Psychological Distress
timeFrame: Instrument will be answered by the patient at baseline (at treatment decision)
measure: Psychological Distress
timeFrame: Instrument will be answered by the patient at approximately 1 week preoperative.
measure: Psychological Distress
timeFrame: Instrument will be answered by the patient after surgery at 6 months postoperative.
measure: Psychological Distress
timeFrame: Instrument will be answered by the patient after surgery at 12 months postoperative.
measure: Sickness absence/work
timeFrame: Instrument will be answered by the patient at baseline (at treatment decision).
measure: Sickness absence/work
timeFrame: Instrument will be answered by the patient at approximately 1 week preoperative.
measure: Sickness absence/work
timeFrame: Instrument will be answered by the patient after surgery at 6 months postoperative.
measure: Sickness absence/work
timeFrame: Instrument will be answered by the patient after surgery at 12 months postoperative.
measure: Physical activity
timeFrame: Single item question will be answered by the patient at baseline (at treatment decision).
measure: Physical activity
timeFrame: Single item question will be answered by the patient at approximately 1 week preoperative.
measure: Physical activity
timeFrame: Single item question will be answered by the patient after surgery at 6 months postoperative.
measure: Physical activity
timeFrame: Single item question will be answered by the patient after surgery at 12 months postoperative.
measure: Alcohol use
timeFrame: Single item questions will be answered by the patient at baseline (at treatment decision).
measure: Alcohol use
timeFrame: Single item questions will be answered by the patient at approximately 1 week preoperative.
measure: Alcohol use
timeFrame: Single item questions will be answered by the patient after surgery at 6 months postoperative.
measure: Alcohol use
timeFrame: Single item questions will be answered by the patient after surgery at 12 months postoperative.
measure: Tobacco use
timeFrame: Single item questions will be answered by the patient at baseline (at treatment decision).
measure: Tobacco use
timeFrame: Single item questions will be answered by the patient at approximately 1 week preoperative.
measure: Tobacco use
timeFrame: Single item questions will be answered by the patient after surgery at 6 months postoperative.
measure: Tobacco use
timeFrame: Single item questions will be answered by the patient after surgery at 12 months postoperative.
measure: Height
timeFrame: Single item question will be answered by the patient at baseline (at treatment decision).
measure: Weight
timeFrame: Single item question will be answered by the patient at baseline (at treatment decision).
measure: Weight
timeFrame: Single item question will be answered by the patient at approximately 1 week preoperative.
measure: Weight
timeFrame: Single item question will be answered by the patient after surgery at 6 months postoperative.
measure: Weight
timeFrame: Single item question will be answered by the patient after surgery at 12 months postoperative.
measure: Body Mass Index (BMI)
timeFrame: Instrument will be answered by the patient after surgery at baseline (at treatment decision).
measure: Body Mass Index (BMI)
timeFrame: Instrument will be answered by the patient at approximately 1 week preoperative.
measure: Body Mass Index (BMI)
timeFrame: Instrument will be answered by the patient after surgery at 6 months postoperative.
measure: Body Mass Index (BMI)
timeFrame: Instrument will be answered by the patient after surgery at 12 months postoperative.
measure: Dysphagia
timeFrame: Instrument will be answered by the patient at baseline (at treatment decision).
measure: Dysphagia
timeFrame: Instrument will be answered by the patient at approximately 1 week preoperative.
measure: Dysphagia
timeFrame: Instrument will be answered by the patient after surgery at 6 months postoperative.
measure: Dysphagia
timeFrame: Instrument will be answered by the patient after surgery at 12 months postoperative.
measure: Rehabilitation process
timeFrame: Instrument will be answered by the patient at baseline (at treatment decision).
measure: Rehabilitation process
timeFrame: Instrument will be answered by the patient at approximately 1 week preoperative.
measure: Rehabilitation process
timeFrame: Instrument will be answered by the patient after surgery at 6 months postoperative.
measure: Rehabilitation process
timeFrame: Instrument will be answered by the patient after surgery at 12 months postoperative.
Other outcomes:
measure: Demographics
timeFrame: The data will be collected 12 months after surgery.
measure: Overall survival
timeFrame: Up to 1 year after surgery
measure: Incidence and severity of general complications
timeFrame: Up to 30 days postoperative
measure: Change of level of care
timeFrame: Up to 30 days postoperative
measure: Length of stay
timeFrame: from the day before surgery to discharge from the hospital
measure: Rate of re-admission
timeFrame: Up to 30 days postoperative
measure: Discharge destination
timeFrame: The data will be collected 12 months postoperative
Locations:
city: Lund
country: Sweden
facility: Skåne University Hospital
Study officials:
References: