Recovery and Rehabilitation After Lung Cancer Surgery

Depression Clinical Trial

Official title:

Recovery and Rehabilitation After Lung Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399541
• Other study ID #: 59081001
• Status: Completed
• Start date: October 2010
• Est. completion date: April 2018

Study information

• Verified date: August 2018
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2018
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breathlessness
• Depression
• Dyspnea
• Fatigue
• Lung Cancer
• Lung Neoplasms
• Pain

Locations

Country	Name	City	State
Norway	Haukeland Sykehus	Bergen
Norway	Rikshospitalet, OUS	Oslo
Norway	Ullevaal University Hospital	Oslo
Norway	St. Olavs Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	St. Olavs Hospital, Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Key measures that will be the focus of the study is Quality of life.	Data will be collecetd using the self administered questionnaire: EORTC QLQ-C30 + LC13	1 year with 5 measurement points
Secondary	The total burden of symptoms will be one key measures in this observational study.	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.	one year with 5 measuresments
Secondary	A key measure to measure fatigue will be used.	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.	one year with five measurements points
Secondary	A key measures to measure sleep disturbances will be used.	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.	One year with five measurements points
Secondary	A key measures will be used to evaluate social support	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.	One year with two measurements points
Secondary	A self administered questionnaire to measure Anxiety	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.	One year with five measurements points
Secondary	A self administered questionnaire to measure pain	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.	one year with five measurements points
Secondary	Depression is a key measure	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 year with five measurements points
Secondary	One key measures that will be used to evaluate stigma related to having lung cancer in this observational study.	Data will be collected using the self administered questionnaire: Cataldo Lung Cancer Stigma Scale (CLCSS)	1 year with one measurements points