Mindfulness for Lung Cancer Patients and Partners
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Behavioral: Mindfulness Based Stress Reduction |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Mindfulness Based Stress Reduction (MBSR) for Patients With Lung Cancer and Their Partners: a Randomized Controlled Trial. |
- Change from baseline in Psychological Distress at 3 and 6 months [ Time Frame: at 0, 3, 6 months ] [ Designated as safety issue: No ]
- Change from baseline in Marital satisfaction at 3 and 6 months [ Time Frame: at 0, 3, 6 months ] [ Designated as safety issue: No ]
- Change from baseline in Quality of Life at 3 and 6 months [ Time Frame: at 0, 3, 6 months ] [ Designated as safety issue: No ]
- Change from baseline in Medical costs at 3 and 6 months [ Time Frame: at 0, 3, 6 months ] [ Designated as safety issue: No ]
- Change from baseline in Mindfulness Skills at 3 and 6 months [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 220 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Treatment as usual |
Behavioral: Mindfulness Based Stress Reduction
A weekly training of eight sessions lasting two and a half hours.
|
|
Experimental: Mindfulnes Based Stress Reduction
A weekly training of eight session lasting two and a half hours.
|
Behavioral: Mindfulness Based Stress Reduction
A weekly training of eight sessions lasting two and a half hours.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: Melanie PJ Schellekens, MSc | +31243610405 | m.schellekens@psy.umcn.nl |
| Contact: Desirée GM van den Hurk, MANP | +31611038463 | d.vandenhurk@uccz.umcn.nl |
| Netherlands | |
| Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre | Recruiting |
| Nijmegen, Gelderland, Netherlands, 6500HB | |
| Principal Investigator: | Anne EM Speckens, Prof. dr. | Radboud University |
| Principal Investigator: | Miep A van der Drift, Drs. | Radboud University |
| Principal Investigator: | Judith B Prins, Prof. dr. | Radboud University |
More Information
No publications provided
| Responsible Party: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT01494883 History of Changes |
| Other Study ID Numbers: | MFN 2011-2015 |
| Study First Received: | December 2, 2011 |
| Last Updated: | March 9, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
Mindfulness Based Stress Reduction lung cancer psychological distress caretakers |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013