Lung CancerNCT01399541
Recovery and Rehabilitation After Lung Cancer Surgery
An observational study of Lung Cancer and Pain, run by Oslo University Hospital at 4 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Pain, Fatigue
- How many people
- 300 participants
- Where
- 4 sitesNorway
- Study dates
- Oct 2010to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients with lung cancer patients above the age of 18 that have been treated with surgery, who are able to speak and understand Norwegian,
Who cannot join
- and who suffer no cognitive impairment.
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Haukeland Sykehus
Bergen, 5021
Rikshospitalet, OUS
Oslo, 0037
Ullevaal University Hospital
Oslo, 0407
St. Olavs Hospital
Trondheim, 7006
About this study
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.
Read the 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.
- Conditions
- Lung Cancer, Pain, Fatigue, Depression, Breathlessness
- Keywords
- Symptoms, Symptoms cluster, Fatigue, Depression, Sleeplessness, Social support, Stigma
- Medical subject headings
- Lung Neoplasms, Pain, Fatigue, Depression, Dyspnea, Sleep Initiation and Maintenance Disorders, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Under and over 65 years | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year with 5 measurement points
Secondary outcomes (8)
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.
Measured: one year with 5 measuresments
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.
Measured: one year with five measurements points
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.
Measured: One year with five measurements points
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.
Measured: One year with two measurements points
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.
Measured: One year with five measurements points
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.
Measured: one year with five measurements points
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.
Measured: One year with five measurements points
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)
Measured: 1 year with one measurements points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startOct 2010
- Primary completionApr 2014
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Ullevaal University Hospital
- Responsible party
- Principal investigator, Tone Rustøen, Oslo University Hospital
- Investigators
- Tone Rustøen, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399541
- Sponsor's protocol ID
- 59081001
- Status last verified
- Aug 2018
- First submitted
- 1 Oct 2010
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery and Rehabilitation After Lung Cancer Surgery
- ClinicalTrials.gov ID
- NCT01399541
- Acronym / sponsor ID
- 59081001
- Conditions
- Lung Cancer, Pain, Fatigue, Depression, Breathlessness
- Keywords
- Symptoms, Symptoms cluster, Fatigue, Depression, Sleeplessness, Social support, Stigma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Ullevaal University Hospital
- Study start
- Oct 2010 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Under and over 65 years | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients with lung cancer patients above the age of 18 that have been treated with surgery, who are able to speak and understand Norwegian,
Key exclusion criteria (1 listed)
- and who suffer no cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
The total burden of symptoms will be one key measures in this observational study.
Time frame: one year with 5 measuresments
A key measure to measure fatigue will be used.
Time frame: one year with five measurements points
A key measures to measure sleep disturbances will be used.
Time frame: One year with five measurements points
A key measures will be used to evaluate social support
Time frame: One year with two measurements points
A self administered questionnaire to measure Anxiety
Time frame: One year with five measurements points
A self administered questionnaire to measure pain
Time frame: one year with five measurements points
Depression is a key measure
Time frame: One year with five measurements points
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tone Rustøen, PhD principal investigator
Oslo University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Pain, run by Oslo University Hospital at 4 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Key measures that will be the focus of the study is Quality of life. (time frame: 1 year with 5 measurement points). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.