Recovery and Rehabilitation After Lung Cancer Surgery
Recruitment status was Recruiting
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Purpose
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.
| Condition |
|---|
|
Lung Cancer Pain Fatigue Depression Breathlessness |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Recovery and Rehabilitation After Lung Cancer Surgery |
- Key measures that will be the focus of the study is Quality of life. [ Time Frame: 1 year with 5 measurement points ] [ Designated as safety issue: No ]Data will be collecetd using the self administered questionnaire: EORTC QLQ-C30 + LC13
- The total burden of symptoms will be one key measures in this observational study. [ Time Frame: one year with 5 measuresments ] [ Designated as safety issue: No ]The self administered questionnaire: Memorial Assessment scale (MSAS) Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
- A key measure to measure fatigue will be used. [ Time Frame: one year with five measurements points ] [ Designated as safety issue: No ]The self administered questionnaire: Lee Fatigue Scale, LFS. Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
- A key measures to measure sleep disturbances will be used. [ Time Frame: One year with five measurements points ] [ Designated as safety issue: No ]A questionnaire: General sleep disturbances scale (GSDS). Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
- A key measures will be used to evaluate social support [ Time Frame: One year with two measurements points ] [ Designated as safety issue: No ]The self administered questionnaire: Social Provision Scale. Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
- A self administered questionnaire to measure Anxiety [ Time Frame: One year with five measurements points ] [ Designated as safety issue: No ]The self administered questionnaire: State and trait anxiety (STAI). Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
- A self administered questionnaire to measure pain [ Time Frame: one year with five measurements points ] [ Designated as safety issue: No ]The self administered questionnaire: Brief Pain Inventory. Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
- Depression is a key measure [ Time Frame: One year with five measurements points ] [ Designated as safety issue: No ]The self administered questionnaire: Self-report depression scale (CES-D). Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
- One key measures that will be used to evaluate stigma related to having lung cancer in this observational study. [ Time Frame: 1 year with one measurements points ] [ Designated as safety issue: No ]Data will be collected using the self administered questionnaire: Cataldo Lung Cancer Stigma Scale (CLCSS)
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Under and over 65 years |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
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.
Contacts and Locations| Contact: Tone Rustøen, PhD | +4723075462 | tone.rustoen@rr-research.no |
| Contact: Johny Kongerud, PhD | +47 23072517 | johny.kongerud@rikshospitalet.no |
| Norway | |
| Haukeland Sykehus | Recruiting |
| Bergen, Norway, 5021 | |
| Contact: Per Bakke, Phd +47 05300 per.bakke@med.uib.no | |
| Principal Investigator: Per Bakke, Phd | |
| Ullevaal University Hospital | Recruiting |
| Oslo, Norway, 0407 | |
| Contact: Øystein Vengen Vengen, PhD +47 58115216 uxoyve@ous-hf.no | |
| Contact: Jonny Vangen + 47 22118080 Jonny.Vangen@ulleval.no | |
| Sub-Investigator: Jeanette O Lillesø | |
| Rikshospitalet, OUS | Recruiting |
| Oslo, Norway, 0037 | |
| Contact: Johny Kongerud, Phd +4723072517 johny.kongerud@rikshospitalet.no | |
| Contact: Trine Oksholm, Master +4791173965 trine.oksholm@rikshospitalet.no | |
| St. Olavs Hospital | Recruiting |
| Trondheim, Norway, 7006 | |
| Contact: Anne H Henriksen, PhD +47 815 55 850 anne.henriksen@stolav.no | |
| Contact: Kari H Gjeilo, PhD +47 815 55 850 Kari.Gjeilo@stolav.no | |
| Sub-Investigator: Heidi Korstad | |
| Principal Investigator: | Tone Rustøen, PhD | Oslo University Hospital |
More Information
No publications provided
| Responsible Party: | Tone Rustøen, Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT01399541 History of Changes |
| Other Study ID Numbers: | 59081001 |
| Study First Received: | October 1, 2010 |
| Last Updated: | July 20, 2011 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by Oslo University Hospital:
|
Symptoms Symptoms cluster Fatigue Depression |
Sleeplessness Social support Stigma |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Dyspnea Fatigue Lung Neoplasms Behavioral Symptoms Mood Disorders Mental Disorders Respiration Disorders |
Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
ClinicalTrials.gov processed this record on May 23, 2013