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History of Changes for Study: NCT02138513
(Cost-)Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Cancer Patients (BeMind)
Latest version (submitted September 18, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 12, 2014 None (earliest Version on record)
2 January 12, 2015 Study Status, Eligibility, Arms and Interventions and Study Description
3 January 25, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
4 February 22, 2016 Study Status and Study Design
5 September 18, 2017 Recruitment Status and Study Status
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Study NCT02138513
Submitted Date:  May 12, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2012.WO14.C153
Brief Title: (Cost-)Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Cancer Patients (BeMind)
Official Title: (Cost-) Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) in Cancer Patients: a Superiority Trial of Online and Face-to-face Treatment Versus Treatment as Usual (TAU).
Secondary IDs: NL46338.091.13 [Registry Identifier: Toetsingonline]
Open or close this module Study Status
Record Verification: May 2014
Overall Status: Recruiting
Study Start: April 2014
Primary Completion: September 2016 [Anticipated]
Study Completion:
First Submitted: May 6, 2014
First Submitted that
Met QC Criteria:
May 12, 2014
First Posted: May 14, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 12, 2014
Last Update Posted: May 14, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Radboud University Medical Center
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

Mindfulness-based cognitive therapy has been demonstrated to be effective in reducing anxiety, depression and fatigue in cancer patients. As this intervention can be offered in groups, costs are relatively low. In addition, delivering MBCT online might make the intervention more accessible and cost-effectiveness. However, more information is needed about what treatment works best for which patient.

Therefore, the aim of this study is to investigate clinical and cost-effectiveness of both individual MBCT online and MBCT offered as a group training compared to TAU .

Study design: The design of the study will be a multi-centre, randomised, superiority trial, comparing MBCT online and MBCT offered as a group training with TAU. Participants in the TAU condition will be randomised to one of the treatment conditions after 3 months. Main assessments will take place at baseline (T0), post-treatment (T1), and 3 (T2) and 9 months after post-treatment (T3).

We expect the MBCT conditions to be superior to TAU in terms of improving mindfulness skills, anxiety and depressive compants, psychological well-being, rumination and fear of cancer recurrence. We also expect the MBCT to result in patients returning to work earlier, have a higher work ability and have lower medical care costs.

Detailed Description:
Open or close this module Conditions
Conditions: Distress
Anxiety
Depression
Keywords: Mindfulness
MBCT
Cancer
Oncology
E-health
Cost-effectiveness
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 3
Masking: Single (Investigator)
Allocation: Randomized
Enrollment: 245 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Online MBCT Behavioral: Mindfulness Based Cognitive Therapy
This MBCT protocol consists of 8 weekly sessions of 2,5 hours each and a silent day of 6 hours of meditation practice. In the online MBCT condition, this is replaced by a Participants will be asked to practice at home for 45 minutes, 6 days a week. They will receive files with meditation and yoga exercises to support this.
Experimental: group MBCT Behavioral: Mindfulness Based Cognitive Therapy
This MBCT protocol consists of 8 weekly sessions of 2,5 hours each and a silent day of 6 hours of meditation practice. In the online MBCT condition, this is replaced by a Participants will be asked to practice at home for 45 minutes, 6 days a week. They will receive files with meditation and yoga exercises to support this.
No Intervention: Treatment as usual
3 months waiting list, subsequent assignment to group or online MBCT
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change from baseline in anxiety and depressive symptoms
[ Time Frame: 0 (baseline), 3 months (post intervention) ]

Anxiety and depressive symptoms as assessed by the Hospital Anxiety and Depression-scale (HADS). The HADS is a self-report questionnaire that comprises 14 items measuring feelings of generalized fear and depressive symptoms. The HADS is considered a reliable and valid instrument for assessing anxiety and depression in medical patients and is sensitive to change (Herrmann, 1997; Bjelland et al., 2002). This instrument was also validated in a palliative cancer population (Akechi, 2006).
Secondary Outcome Measures:
1. Change from baseline in fear of cancer recurrence
[ Time Frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up) ]

Fear of cancer recurrence will be assessed with the Fear of Cancer Recurrence Inventory (FCRI; Simard & Savard, 2009a; van der Lee et al., 2012).
2. DSM-IV Axis I mood or anxiety disorders
[ Time Frame: 0, 3 (post intervention), 12 months (9mo follow-up) ]

DSM IV Axis I psychiatric disorder as diagnosed by a structured interview
3. Change from baseline in positive mental health
[ Time Frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up) ]

The Mental Health Continuum-Short Form (MHC-SF) measures positive mental health and comprises 14 items, representing various feelings of well-being. Respondents rate the frequency of every feeling in the past month on a 6-point Likert scale (never, once or twice a month, about once a week, two or three times a week, almost every day, every day). The MHC-SF contains three subscales: emotional, psychological and social well-being. MHC-SF has shown high internal and moderate test-retest reliability, convergent and discriminant validity.
4. Change from baseline in healthcare consumption
[ Time Frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up) ]

The TIC-P generates quantitative data about direct medical costs and indirect societal costs as a consequence of psychological/psychiatric illnesses.
5. Change from baseline in health-related quality of life
[ Time Frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up) ]

To measure the quality of the health status of cancer patients a validated health-related quality of life (HRQoL) instrument will be used, the EuroQol-5D (EQ-5D). This HRQoL instrument will be completed by the patient together with a researcher and is available in a validated Dutch translation (Lamers, 2005). The EQ-5D is a generic HRQoL instrument comprising five domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D index is obtained by applying predetermined weights to the five domains. This index gives a societal-based global quantification of the participant's health status on a scale ranging from 0 (death) to 1 (perfect health). Participants will also be asked to rate their overall HRQoL on a visual analogue scale (EQ- 5D VAS) consisting of a vertical line ranging from 0 (worst imaginable health status) to 100 (best imaginable).
6. Change from baseline in health-related quality of life
[ Time Frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up) ]

In addition to the EQ-5D, the SF-12 will be administered for explorative purposes for there are indications that the SF-12 is more sensitive for changes in HRQol in populations with less severe morbidity (Johnson and Coons, 1998).
7. Change from baseline in mindfulness skills
[ Time Frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up) ]

The 39-item Five Facet Mindfulness Questionnaire has been developed as a reliable and valid comprehensive instrument for assessing different aspects of mindfulness. A Dutch 24-item short form of the FFMQ (FFMQ-SF) was developed and assessed in a sample of 376 adults with clinically relevant symptoms of depression and anxiety and cross-validated in an independent sample of patients with fibromyalgia. Confirmatory factor analyses showed good model fit for the five-factor structure of the FFMQ-SF: observing, describing, acting with awareness, nonjudging, and nonreactivity. The FFMQ-SF was related to measures of psychological symptoms, well-being, experiential avoidance, and the personality factors neuroticism and openness to experience.
8. Change from baseline in rumination
[ Time Frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up) ]

The rumination subscale of the RRQ assesses a neurotic self-attentiveness (i.e. recurrent, primarily past-oriented thinking about the self), which is prompted by threats, losses, of injustices to the self. Subjects rate their level of agreement of disagreement on a five-point rating scale (e.g., "I always seem to be rehashing in my mind recent things I've said or done"). There is evidence of good internal consistency (.90) and stability over a 10-month period and convergent validity. The measure in the current study was translated into Dutch using the guidelines of the International Test Commission (Hambleton, 1994). Cronbach's alphas were .88 and .90 in Sample 1, and .90 and .91 in Sample 2, respectively (Luyckx et al., 2008).
9. Change from baseline in personality assessment
[ Time Frame: 0 (baseline) and 12 months (9mo follow-up) ]

Personality is measured with the NEO Five Factor Inventory (NEO-FFI, Costa & McCrae, 1992) which consists of five domains: neuroticism, extraversion, openness, altruism, and conscientiousness.
10. Change in mindfulness skills during intervention
[ Time Frame: week 2,3,4,5,6,7,8 and 9 of intervention ]

The Mindful Attention Awareness Scale (MAAS) will be administered before each MBCT session to assess mindful attention in daily life
11. Group cohesion during intervention
[ Time Frame: week 4 and week 9 during intervention ]

We will examine self-reported individual group cohesion ratings during the MBCT training with a Dutch Group Cohesion Questionnaire that has been used in cancer patients before (May et al., 2008). The GCQ-23 uses 22 items across four scales: the bond with the group as whole, the bond with other members, cooperation within the group and the instrumental value. Each item is rated from 1 (totally disagree) to 6 (totally agree). Internal consistency of all scales was reported to range from adequate to good (0.66-0.88).
12. Working alliance during intervention
[ Time Frame: week 4 and week 9 during intervention ]

The Working Alliance Inventory (WAI) is most often used to assess working alliance between participant and healthcare professional. We will use the Dutch translation of the short form (WAI-S, Vervaeke & Vertommen, 1996), which is closely related to the original scale and also has good psychometric and predictive quality (Busseri & Tyler, 2003). The WAI-S is a 12 item, self report questionnaire, rated on a 7-point Likert scale (1 = never to 7 = always) with three subscales: 1) agreement between participant and therapist on the goals of the therapy; 2) agreement on the rationale of the therapy addressing the problems of the participant; and 3) the quality of the interpersonal bond between the participant and the therapist.
13. Change in mood during intervention
[ Time Frame: week 2,3,4,5,6,7,8 and 9 of intervention ]

In the current study, positive and negative affect is assessed before each MBCT session using the International Positive and Negative Affect Scale - Short Form. The cross-sample stability, internal reliability, temporal stability, crosscultural factorial invariance, and convergent and criterion-related validities of the I-PANAS-SF were examined and found to be psychometrically acceptable (Thompson, 2007).
14. Change from baseline in anxiety and depressive symptoms - follow up
[ Time Frame: 0, (baseline) 6 (3mo follow-up) and 12 months (9mo follow-up) ]

Hospital Anxiety and Depression Scale - anxiety and depressive symptoms at follow up.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • HADS ≥ 11
  • Cancer diagnosis (at present or past)
  • Stable dose if using psychopharmacological medication for at least 3 months
  • computer literacy and acces to internet
  • capable of filling out questionnaires in Dutch

Exclusion Criteria:

  • severe psychiatric morbidity as psychoses, suicidal ideation
  • previous mindfulness-based treatment regarding anxiety, depression or fatigue in the last two months.
Open or close this module Contacts/Locations
Central Contact Person: Félix R Compen, MSc
Telephone: 0031243610405
Email: felix.compen@radboudumc.nl
Central Contact Backup: Else M Bisseling, Drs
Telephone: 0031243610405
Email: ebisseling@hdi.nl
Study Officials: Anne EM Speckens, MD, PhD
Principal Investigator
Radboud University Medical Centre Nijmegen
Locations: Netherlands, Gelderland
Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre
[Recruiting]
Nijmegen, Gelderland, Netherlands, 6500HB
Contact:Principal Investigator: Anne EM Speckens, MD, PhD
Contact:Sub-Investigator: Else M Bisseling, MD
Contact:Sub-Investigator: Félix R Compen, MSc
Netherlands, Utrecht
Helen Dowling Institute
[Recruiting]
Bilthoven, Utrecht, Netherlands, 3723 MB
Contact:Principal Investigator: Marije L van der Lee, PhD
Contact:Sub-Investigator: Félix R Compen, MSc
Contact:Sub-Investigator: Else M Bisseling, MD
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Open or close this module References
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