Clinical trial NCT01399541: Recovery and Rehabilitation After Lung Cancer Surgery
Official title: Recovery and Rehabilitation After Lung Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Pain
Fatigue
Depression
Breathlessness
Keywords: Symptoms
Symptoms cluster
Fatigue
Depression
Sleeplessness
Social support
Stigma
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Ullevaal University Hospital
First posted: 2011-07-21
Enrollment: 300
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: Eligible patients are lung cancer patients above the age of 18 that have been treated with surgery, who are able to speak and understand Norwegian, and who suffer no cognitive impairment. The patients in the study must give written informed consent to participation in the study. It is estimated that we need 300 patients.

Brief summary: The specific aims of this translational, interdisciplinary, multi-center, international research study with 300 Lung cancer patients are to:

Aim 1 Explore how the patients experience the transfer between different locations and between different levels of care at the same location and how they experienced coming home.

Aim 2 Explore lung cancer patients' symptoms, symptom clusters, and changes in symptoms and symptom clusters over time.

Aim 3 Explore interaction between lung cancers patients' symptoms, symptom clusters, health related quality of life and social support.

Detailed description: Approximately 2500 patients are diagnosed with lung cancer annually i Norway, and approximately 400 of these undergo surgery. Many patients report that life after lung cancer surgery is difficult. After surgery, the patients are frequently transferred to a local hospital or to another level of care at the hospital where they were operated. The transfer is critical for patients' safety because communication failure is one of the most common causes of medical error.

Studies that have analyzed the quality of life of lung cancer patients after surgery reach different conclusions about the patients' Quality of life (QOL), some studies state that lung cancer patients are back to normal quality of life after 9 months, while others indicate that the patients still have reduced QOL two years after surgery. It is difficult to assess the reason for the differences in results as most of the studies used the same QOL questionnaire. Studies that have evaluated the social support that lung cancer patients receive indicate that lung cancer patients receive less support than other cancer patients.

Lung cancer patients have a wide range of physical problems (fatigue, dyspnea, coughing and pain) and psychological (depression) problems following surgery.

Based on findings from this literature review a need exist for improved postoperative follow-up of patients after surgery for lung cancer The proposed study will evaluate the social support, the levels of lung cancer stigma, symptoms and changes in this over time as well as evaluate patient experience with transfer in the immediate postoperative period.

Eligibility criteria: Inclusion Criteria:

* patients with lung cancer patients above the age of 18 that have been treated with surgery, who are able to speak and understand Norwegian,

Exclusion Criteria:

* and who suffer no cognitive impairment.

Primary outcomes:
measure: Key measures that will be the focus of the study is Quality of life.
timeFrame: 1 year with 5 measurement points
Secondary outcomes:
measure: The total burden of symptoms will be one key measures in this observational study.
timeFrame: one year with 5 measuresments
measure: A key measure to measure fatigue will be used.
timeFrame: one year with five measurements points
measure: A key measures to measure sleep disturbances will be used.
timeFrame: One year with five measurements points
measure: A key measures will be used to evaluate social support
timeFrame: One year with two measurements points
measure: A self administered questionnaire to measure Anxiety
timeFrame: One year with five measurements points
measure: A self administered questionnaire to measure pain
timeFrame: one year with five measurements points
measure: Depression is a key measure
timeFrame: One year with five measurements points
measure: One key measures that will be used to evaluate stigma related to having lung cancer in this observational study.
timeFrame: 1 year with one measurements points
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland Sykehus
city: Oslo
country: Norway
facility: Rikshospitalet, OUS
city: Oslo
country: Norway
facility: Ullevaal University Hospital
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Oslo University Hospital
name: Tone Rustøen, PhD
role: PRINCIPAL_INVESTIGATOR
References: