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Mindfulness Based Stress Reduction (MBSR) for Patients With Lung Cancer and Their Partners: a Randomized Controlled Trial.


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Mindfulness Based Stress Reduction (MBSR) for Patients With Lung Cancer and Their Partners: a Randomized Controlled Trial.


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Change from baseline in Psychological Distress at 3 and 6 months

Outcome Time Frame:

at 0, 3, 6 months

Safety Issue:

No

Principal Investigator

Anne EM Speckens, Prof. dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

MFN 2011-2015

NCT ID:

NCT01494883

Start Date:

February 2012

Completion Date:

January 2015

Related Keywords:

  • Lung Cancer
  • Mindfulness Based Stress Reduction
  • lung cancer
  • psychological distress
  • caretakers
  • Lung Neoplasms

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