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(Cost-)Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Cancer Patients (BeMind)

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ClinicalTrials.gov Identifier: NCT02138513
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Radboud University

Tracking Information
First Submitted Date  ICMJE May 6, 2014
First Posted Date  ICMJE May 14, 2014
Last Update Posted Date September 19, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date July 20, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02138513 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
  • 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).
  • 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
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
  • 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).
  • 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.
  • 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
  • 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).
  • 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.
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE (Cost-)Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Cancer Patients
Official Title  ICMJE (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).
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, thereby being more cost-effective than TAU.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Distress
  • Anxiety
  • Depression
Intervention  ICMJE 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. Similar to group MBCT, in the online MBCT group, 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.
Study Arms  ICMJE
  • Experimental: Online MBCT
    Intervention: Behavioral: Mindfulness Based Cognitive Therapy
  • Experimental: group MBCT
    Intervention: Behavioral: Mindfulness Based Cognitive Therapy
  • No Intervention: Treatment as usual
    3 months waiting list, subsequent assignment to group or online MBCT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2014)
245
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1, 2017
Actual Primary Completion Date July 20, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02138513
Other Study ID Numbers  ICMJE 2012.WO14.C153
NL46338.091.13 ( Registry Identifier: Toetsingonline )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne EM Speckens, MD, PhD Radboud University Medical Centre Nijmegen
PRS Account Radboud University
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP