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Mindfulness for Lung Cancer Patients and Partners

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Mindfulness Based Stress Reduction, lung cancer, psychological distress, caretakers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as usual

Mindfulnes Based Stress Reduction

Arm Description

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

Outcomes

Primary Outcome Measures

Change from baseline in Psychological Distress at 3 and 6 months

Secondary Outcome Measures

Change from baseline in Marital satisfaction at 3 and 6 months
Change from baseline in Quality of Life at 3 and 6 months
Change from baseline in Medical costs at 3 and 6 months
Change from baseline in Mindfulness Skills at 3 and 6 months

Full Information

First Posted
December 2, 2011
Last Updated
September 9, 2015
Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT01494883
Brief Title
Mindfulness for Lung Cancer Patients and Partners
Official Title
Mindfulness Based Stress Reduction (MBSR) for Patients With Lung Cancer and Their Partners: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Mindfulness Based Stress Reduction, lung cancer, psychological distress, caretakers

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Title
Mindfulnes Based Stress Reduction
Arm Type
Experimental
Arm Description
A weekly training of eight session lasting two and a half hours.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction
Intervention Description
A weekly training of eight sessions lasting two and a half hours.
Primary Outcome Measure Information:
Title
Change from baseline in Psychological Distress at 3 and 6 months
Time Frame
at 0, 3, 6 months
Secondary Outcome Measure Information:
Title
Change from baseline in Marital satisfaction at 3 and 6 months
Time Frame
at 0, 3, 6 months
Title
Change from baseline in Quality of Life at 3 and 6 months
Time Frame
at 0, 3, 6 months
Title
Change from baseline in Medical costs at 3 and 6 months
Time Frame
at 0, 3, 6 months
Title
Change from baseline in Mindfulness Skills at 3 and 6 months
Time Frame
0, 3, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne EM Speckens, Prof. dr.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miep A van der Drift, Drs.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Judith B Prins, Prof. dr.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24386906
Citation
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.
Results Reference
derived

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Mindfulness for Lung Cancer Patients and Partners

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