Recovery and Rehabilitation After Lung Cancer Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
St. Olavs Hospital
Ullevaal University Hospital
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01399541
First received: October 1, 2010
Last updated: July 20, 2011
Last verified: May 2011
  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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399541

Contacts
Contact: Tone Rustøen, PhD +4723075462 tone.rustoen@rr-research.no
Contact: Johny Kongerud, PhD +47 23072517 johny.kongerud@rikshospitalet.no

Locations
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         
Sponsors and Collaborators
Oslo University Hospital
St. Olavs Hospital
Ullevaal University Hospital
Investigators
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:
Lung Neoplasms
Depression
Depressive Disorder
Fatigue
Dyspnea
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Signs and Symptoms
Respiration Disorders
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on September 15, 2014