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Completed

NCT Number: NCT01399541

Recovery and Rehabilitation After Lung Cancer Surgery

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.

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Key information

Conditions

Lung Cancer Behavior Behavioral Symptoms Breathlessness Depression Dyspnea Dyssomnias Fatigue Lung Diseases Lung Neoplasms Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Social Behavior Social Stigma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland Sykehus, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Key measures that will be the focus of the study is Quality of life.

    Time frame: 1 year with 5 measurement points

    Data will be collecetd using the self administered questionnaire: EORTC QLQ-C30 + LC13

Secondary outcomes

  1. The total burden of symptoms will be one key measures in this observational study.

    Time frame: one year with 5 measuresments

    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.

  2. A key measure to measure fatigue will be used.

    Time frame: one year with five measurements points

    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.

  3. A key measures to measure sleep disturbances will be used.

    Time frame: One year with five measurements points

    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.

  4. A key measures will be used to evaluate social support

    Time frame: One year with two measurements points

    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.

  5. A self administered questionnaire to measure Anxiety

    Time frame: One year with five measurements points

    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.

  6. A self administered questionnaire to measure pain

    Time frame: one year with five measurements points

    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.

  7. Depression is a key measure

    Time frame: One year with five measurements points

    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.

  8. 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

    Data will be collected using the self administered questionnaire: Cataldo Lung Cancer Stigma Scale (CLCSS)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • St. Olavs Hospital
  • Ullevaal University Hospital

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2018
First posted
Jul 21, 2011
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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