NCT01494883

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 19, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 11, 2015

Status Verified

September 1, 2015

Enrollment Period

3.6 years

First QC Date

December 2, 2011

Last Update Submit

September 9, 2015

Conditions

Lung Cancer

Keywords

Mindfulness Based Stress Reductionlung cancerpsychological distresscaretakers

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Psychological Distress at 3 and 6 months

    at 0, 3, 6 months

Secondary Outcomes (4)

  • Change from baseline in Marital satisfaction at 3 and 6 months

    at 0, 3, 6 months

  • Change from baseline in Quality of Life at 3 and 6 months

    at 0, 3, 6 months

  • Change from baseline in Medical costs at 3 and 6 months

    at 0, 3, 6 months

  • Change from baseline in Mindfulness Skills at 3 and 6 months

    0, 3, 6 months

Study Arms (2)

Treatment as usual

NO INTERVENTION

Mindfulnes Based Stress Reduction

EXPERIMENTAL

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

Behavioral: Mindfulness Based Stress Reduction

Interventions

Mindfulness Based Stress ReductionBEHAVIORAL

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

Mindfulnes Based Stress Reduction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 24386906DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Anne EM Speckens, Prof. dr.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Miep A van der Drift, Drs.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Judith B Prins, Prof. dr.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2011

First Posted

December 19, 2011

Study Start

February 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 11, 2015

Record last verified: 2015-09

Locations

NL(1)