Lung CancerNCT01494883
Mindfulness for Lung Cancer Patients and Partners
A study testing Mindfulness Based Stress Reduction in people with Lung Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The aim of the current study is to examine the (cost)effectiveness of mindfulness based stress reduction (MBSR) in comparison with treatment as usual for patients with lung cancer and their partners. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Mindfulness Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2012to Sep 2015
- Phase
- Interventional
- 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
Who may be able to join
- Cytologically or histologically proven non-small cell lung cancer and small cell lung cancer.
- Patients can participate after lung cancer diagnosis, from start of treatment or after treatment.
- Sufficient understanding of Dutch language.
Who cannot join
- Former participation in MBSR or MBCT course.
- Current psychological treatment by psychologist or psychiatrist.
- Cognitive impairments hampering participation in MBSR and completion of questionnaires.
- Physical impairments prohibiting participation in MBSR training.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500HB
About this study
Official title: Mindfulness Based Stress Reduction (MBSR) for Patients With Lung Cancer and Their Partners: a Randomized Controlled Trial.
The aim of the current study is to examine the (cost)effectiveness of mindfulness based stress reduction (MBSR) in comparison with treatment as usual for patients with lung cancer and their partners.
Read the detailed description
Receiving a diagnosis of cancer is a major cause of distress and is usually characterized by anxiety and depression. Compared to patients with other cancer diagnoses, patients with lung cancer report higher levels of distress, which probably can be explained by the poor prognosis. At the time of diagnosis, lung cancer is often locally or systematically advanced and 5-year survival is only 15 percent.
Mindfulness based stress reduction (MBSR) is a recently developed psychological intervention that appears to be promising in terms of reducing psychological distress in cancer patients. It consists of 8 weekly group sessions in which formal and informal mindfulness practices are practiced. As most of the earlier studies have been conducted in patients with breast cancer, it is important to examine the effectiveness of this approach in patients with other types of cancer, such as lung cancer. Furthermore, a diagnosis of cancer is not only highly distressing for the patient but also for the partner and family.
In this study, the (cost)effectiveness of MBSR compared with treatment as usual will be investigated in 110 patients with lung cancer and 110 partners.
- Conditions
- Lung Cancer
- Being tested
- Mindfulness Based Stress Reduction
- Keywords
- Mindfulness Based Stress Reduction, lung cancer, psychological distress, caretakers
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress ReductionBehavioural
A weekly training of eight sessions lasting two and a half hours.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Not described |
| Mindfulnes Based Stress Reduction | Experimental | A weekly training of eight session lasting two and a half hours. Receives: Behavioral: Mindfulness Based Stress Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Psychological Distress at 3 and 6 months
Measured: at 0, 3, 6 months
Secondary outcomes (4)
Change from baseline in Marital satisfaction at 3 and 6 months
Measured: at 0, 3, 6 months
Change from baseline in Quality of Life at 3 and 6 months
Measured: at 0, 3, 6 months
Change from baseline in Medical costs at 3 and 6 months
Measured: at 0, 3, 6 months
Change from baseline in Mindfulness Skills at 3 and 6 months
Measured: 0, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Sponsor
- Investigators
- Anne EM Speckens, Prof. dr., Principal investigator, Radboud University Medical CenterMiep A van der Drift, Drs., Principal investigator, Radboud University Medical CenterJudith B Prins, Prof. dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494883
- Sponsor's protocol ID
- MFN 2011-2015
- Status last verified
- Sep 2015
- First submitted
- 2 Dec 2011
- Last updated
- 11 Sep 2015
- Results posted
- No
Publications
Schellekens MP, van den Hurk DG, Prins JB, Molema J, Donders AR, Woertman WH, van der Drift MA, Speckens AE. Study protocol of a randomized controlled trial comparing Mindfulness-Based Stress Reduction with treatment as usual in reducing psychological distress in patients with lung cancer and their partners: the MILON study. BMC Cancer. 2014 Jan 3;14:3. doi: 10.1186/1471-2407-14-3.
PubMed 24386906
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Stress Reduction (MBSR) for Patients With Lung Cancer and Their Partners: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01494883
- Acronym / sponsor ID
- MFN 2011-2015
- Conditions
- Lung Cancer
- Keywords
- Mindfulness Based Stress Reduction, lung cancer, psychological distress, caretakers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- Feb 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Dec 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 aim of the current study is to examine the (cost)effectiveness of mindfulness based stress reduction (MBSR) in comparison with treatment as usual for patients with lung cancer and their partners.
Detailed description
Receiving a diagnosis of cancer is a major cause of distress and is usually characterized by anxiety and depression. Compared to patients with other cancer diagnoses, patients with lung cancer report higher levels of distress, which probably can be explained by the poor prognosis. At the time of diagnosis, lung cancer is often locally or systematically advanced and 5-year survival is only 15 percent.
Mindfulness based stress reduction (MBSR) is a recently developed psychological intervention that appears to be promising in terms of reducing psychological distress in cancer patients. It consists of 8 weekly group sessions in which formal and informal mindfulness practices are practiced. As most of the earlier studies have been conducted in patients with breast cancer, it is important to examine the effectiveness of this approach in patients with other types of cancer, such as lung cancer. Furthermore, a diagnosis of cancer is not only highly distressing for the patient but also for the partner and family.
In this study, the (cost)effectiveness of MBSR compared with treatment as usual will be investigated in 110 patients with lung cancer and 110 partners.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | – |
| Mindfulnes Based Stress Reduction | Experimental | Behavioral: Mindfulness Based Stress ReductionA weekly training of eight session lasting two and a half hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cytologically or histologically proven non-small cell lung cancer and small cell lung cancer.
- Patients can participate after lung cancer diagnosis, from start of treatment or after treatment.
- Sufficient understanding of Dutch language.
Key exclusion criteria (4 listed)
- Former participation in MBSR or MBCT course.
- Current psychological treatment by psychologist or psychiatrist.
- Cognitive impairments hampering participation in MBSR and completion of questionnaires.
- Physical impairments prohibiting participation in MBSR training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Stress ReductionA weekly training of eight sessions lasting two and a half hours. | Behavioural | Mindfulnes Based Stress Reduction |
Primary outcome
Change from baseline in Psychological Distress at 3 and 6 months
Time frame: at 0, 3, 6 months
4 secondary outcomes
Change from baseline in Marital satisfaction at 3 and 6 months
Time frame: at 0, 3, 6 months
Change from baseline in Quality of Life at 3 and 6 months
Time frame: at 0, 3, 6 months
Change from baseline in Medical costs at 3 and 6 months
Time frame: at 0, 3, 6 months
Change from baseline in Mindfulness Skills at 3 and 6 months
Time frame: 0, 3, 6 months
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 11 Sep 2015.
- Derived from this study: PubMed 24386906Schellekens MP, van den Hurk DG, Prins JB, Molema J, Donders AR, Woertman WH, van der Drift MA, Speckens AE. Study protocol of a randomized controlled trial comparing Mindfulness-Based Stress Reduction with treatment as usual in reducing psychological distress in patients with lung cancer and their partners: the MILON study. BMC Cancer. 2014 Jan 3;14:3. doi: 10.1186/1471-2407-14-3.
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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.
Anne EM Speckens, Prof. dr. principal investigator
Radboud University Medical Center
Miep A van der Drift, Drs. principal investigator
Radboud University Medical Center
Judith B Prins, Prof. dr. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction in people with Lung Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 4 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 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Change from baseline in Psychological Distress at 3 and 6 months (time frame: at 0, 3, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01494883, which also lists 1 linked publication.
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 11 Sep 2015.