Mindfulness for Lung Cancer Patients and Partners

NCT ID: NCT01494883

Last Updated: 2015-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-09-30

Brief Summary

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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

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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

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Mindfulnes Based Stress Reduction

A weekly training of eight session lasting two and a half hours.

Group Type EXPERIMENTAL

Mindfulness Based Stress Reduction

Intervention Type BEHAVIORAL

A weekly training of eight sessions lasting two and a half hours.

Interventions

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Mindfulness Based Stress Reduction

A weekly training of eight sessions lasting two and a half hours.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dutch Cancer Society

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne EM Speckens, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Miep A van der Drift, Drs.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Judith B Prins, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 24386906 (View on PubMed)

Other Identifiers

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MFN 2011-2015

Identifier Type: -

Identifier Source: org_study_id

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