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

Melanie P. J. Schellekens; Desiree G. M. van den Hurk; Judith B. Prins; Johan Molema; A. Rogier T. Donders; Willem H. Woertman; Miep A. van der Drift; Anne E. M. Speckens

doi:10.1186/1471-2407-14-3

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

Melanie P. J. Schellekens^*
, Desiree G. M. van den Hurk
, Judith B. Prins
, Johan Molema
, A. Rogier T. Donders
, Willem H. Woertman
, Miep A. van der Drift
, Anne E. M. Speckens

^*Corresponding author for this work

Research output: Contribution to journal › Article › Scientific › peer-review

Abstract

Background
Lung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis. It has a major impact on the psychological wellbeing of patients and their partners. Recently, it has been shown that Mindfulness-Based Stress Reduction (MBSR) is effective in reducing anxiety and depressive symptoms in cancer patients. The generalization of these results is limited since most participants were female patients with breast cancer. Moreover, only one study examined the effectiveness of MBSR in partners of cancer patients. Therefore, in the present trial we study the effectiveness of MBSR versus treatment as usual (TAU) in patients with lung cancer and their partners.

Methods/Design
A parallel group, randomized controlled trial is conducted to compare MBSR with TAU. Lung cancer patients who have received or are still under treatment, and their partners are recruited. Assessments will take place at baseline, post intervention and at three-month follow-up. The primary outcome is psychological distress (i.e. anxiety and depressive symptoms). Secondary outcomes are quality of life (only for patients), caregiver appraisal (only for partners), relationship quality and spirituality. In addition, cost-effectiveness ratio (only in patients) and several process variables are assessed.

Discussion
This trial will provide information about the clinical and cost-effectiveness of MBSR compared to TAU in patients with lung cancer and their partners.

Original language	English
Article number	3
Number of pages	9
Journal	BMC Cancer
Volume	14
DOIs	https://doi.org/10.1186/1471-2407-14-3
Publication status	Published - 2014
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Mindfulness-based stress reduction
Lung cancer patients
partners
psychological distress
randomized controlled trial

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Schellekens, M. P. J., van den Hurk, D. G. M., Prins, J. B., Molema, J., Donders, A. R. T., Woertman, W. H., van der Drift, M. A., & Speckens, A. E. M. (2014). 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, 14, Article 3. https://doi.org/10.1186/1471-2407-14-3

@article{8e64fe0490dd48cab921691ca137dde8,

title = "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",

abstract = "Background Lung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis. It has a major impact on the psychological wellbeing of patients and their partners. Recently, it has been shown that Mindfulness-Based Stress Reduction (MBSR) is effective in reducing anxiety and depressive symptoms in cancer patients. The generalization of these results is limited since most participants were female patients with breast cancer. Moreover, only one study examined the effectiveness of MBSR in partners of cancer patients. Therefore, in the present trial we study the effectiveness of MBSR versus treatment as usual (TAU) in patients with lung cancer and their partners. Methods/Design A parallel group, randomized controlled trial is conducted to compare MBSR with TAU. Lung cancer patients who have received or are still under treatment, and their partners are recruited. Assessments will take place at baseline, post intervention and at three-month follow-up. The primary outcome is psychological distress (i.e. anxiety and depressive symptoms). Secondary outcomes are quality of life (only for patients), caregiver appraisal (only for partners), relationship quality and spirituality. In addition, cost-effectiveness ratio (only in patients) and several process variables are assessed. Discussion This trial will provide information about the clinical and cost-effectiveness of MBSR compared to TAU in patients with lung cancer and their partners.",

keywords = "Mindfulness-based stress reduction, Lung cancer patients, partners, psychological distress, randomized controlled trial",

author = "Schellekens, \{Melanie P. J.\} and \{van den Hurk\}, \{Desiree G. M.\} and Prins, \{Judith B.\} and Johan Molema and Donders, \{A. Rogier T.\} and Woertman, \{Willem H.\} and \{van der Drift\}, \{Miep A.\} and Speckens, \{Anne E. M.\}",

year = "2014",

doi = "10.1186/1471-2407-14-3",

language = "English",

volume = "14",

journal = "BMC Cancer",

issn = "1471-2407",

publisher = "BioMed Central Ltd.",

}

Schellekens, MPJ, van den Hurk, DGM, Prins, JB, Molema, J, Donders, ART, Woertman, WH, van der Drift, MA & Speckens, AEM 2014, '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, vol. 14, 3. https://doi.org/10.1186/1471-2407-14-3

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. / Schellekens, Melanie P. J.; van den Hurk, Desiree G. M.; Prins, Judith B. et al.
In: BMC Cancer, Vol. 14, 3, 2014.

Research output: Contribution to journal › Article › Scientific › peer-review

TY - JOUR

T1 - 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

T2 - the MILON study

AU - Schellekens, Melanie P. J.

AU - van den Hurk, Desiree G. M.

AU - Prins, Judith B.

AU - Molema, Johan

AU - Donders, A. Rogier T.

AU - Woertman, Willem H.

AU - van der Drift, Miep A.

AU - Speckens, Anne E. M.

PY - 2014

Y1 - 2014

N2 - Background Lung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis. It has a major impact on the psychological wellbeing of patients and their partners. Recently, it has been shown that Mindfulness-Based Stress Reduction (MBSR) is effective in reducing anxiety and depressive symptoms in cancer patients. The generalization of these results is limited since most participants were female patients with breast cancer. Moreover, only one study examined the effectiveness of MBSR in partners of cancer patients. Therefore, in the present trial we study the effectiveness of MBSR versus treatment as usual (TAU) in patients with lung cancer and their partners. Methods/Design A parallel group, randomized controlled trial is conducted to compare MBSR with TAU. Lung cancer patients who have received or are still under treatment, and their partners are recruited. Assessments will take place at baseline, post intervention and at three-month follow-up. The primary outcome is psychological distress (i.e. anxiety and depressive symptoms). Secondary outcomes are quality of life (only for patients), caregiver appraisal (only for partners), relationship quality and spirituality. In addition, cost-effectiveness ratio (only in patients) and several process variables are assessed. Discussion This trial will provide information about the clinical and cost-effectiveness of MBSR compared to TAU in patients with lung cancer and their partners.

AB - Background Lung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis. It has a major impact on the psychological wellbeing of patients and their partners. Recently, it has been shown that Mindfulness-Based Stress Reduction (MBSR) is effective in reducing anxiety and depressive symptoms in cancer patients. The generalization of these results is limited since most participants were female patients with breast cancer. Moreover, only one study examined the effectiveness of MBSR in partners of cancer patients. Therefore, in the present trial we study the effectiveness of MBSR versus treatment as usual (TAU) in patients with lung cancer and their partners. Methods/Design A parallel group, randomized controlled trial is conducted to compare MBSR with TAU. Lung cancer patients who have received or are still under treatment, and their partners are recruited. Assessments will take place at baseline, post intervention and at three-month follow-up. The primary outcome is psychological distress (i.e. anxiety and depressive symptoms). Secondary outcomes are quality of life (only for patients), caregiver appraisal (only for partners), relationship quality and spirituality. In addition, cost-effectiveness ratio (only in patients) and several process variables are assessed. Discussion This trial will provide information about the clinical and cost-effectiveness of MBSR compared to TAU in patients with lung cancer and their partners.

KW - Mindfulness-based stress reduction

KW - Lung cancer patients

KW - partners

KW - psychological distress

KW - randomized controlled trial

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U2 - 10.1186/1471-2407-14-3

DO - 10.1186/1471-2407-14-3

M3 - Article

C2 - 24386906

SN - 1471-2407

VL - 14

JO - BMC Cancer

JF - BMC Cancer

M1 - 3

ER -

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

Abstract

UN SDGs

Keywords

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