Esophageal Cancer, Esophageal Neoplasms, Gastric Cancer, Stomach Neoplasm
Conditions
Keywords
Cancer rehabilitation, Recovery
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.
Interventions
OTHERevidence-based individualized rehabilitation
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.
Sponsors
Region Skane
Karolinska Institutet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General Quality of life | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal and gastric cancer specific Quality of life | 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. |
| Information needs | 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). |
| International Physical Activity Questionnaire | 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. |
| Hospital Anxiety and Depression Scale | 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. |
| Assessment of Survivorship Concerns | 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. |
| Resilience | 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. |
| Assessment of rehabilitation needs. | 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. |
| Psychological Distress | 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. |
| Sickness absence/work | 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. |
| Physical activity | 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. |
| Alcohol use | Single item questions will be answered by the patient at baseline (at treatment decision). | Single item questions concerning alcohol use. |
| Tobacco use | Single item questions will be answered by the patient at baseline (at treatment decision). | Single item questions concerning tobacco use. |
| Height | Single item question will be answered by the patient at baseline (at treatment decision). | Single item question concerning height in meters. |
| Weight | Single item question will be answered by the patient at baseline (at treatment decision). | Single item question concerning weight in kilograms. |
| Body Mass Index (BMI) | 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. |
| Dysphagia | 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. |
| Rehabilitation process | 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. |
Countries
Sweden
Contacts
CONTACTWenche Melander, PhD-student
CONTACTMarlene Malmström, PhD
Outcome results
None listed