MBCT for Cancer Patients in Follow-Up

May 24, 2019 updated by: University of Aarhus

Mindfulness-based Cognitive Therapy for Pain in Cancer Patients After Primary Treatment: An Open Implementation Trial

The objectives of the present study are: 1) to executing the practical implementation in an oncology department of MBCT for patients who have completed their primary treatment and experience significant cancer- and cancer-treatment-related pain, 2) to evaluate effects on pain and well-being, 3) to explore patient satisfaction with the intervention offered, and 4) to explore possible organizational and individual physical, mental and socio-economic barriers for implementation in relation to drop-outs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

International research shows that untreated or under treated pain among cancer patients after completion of therapy is a common problem with substantial negative impact on the patients' quality of life and mental and physical function.These challenges have increased interest in psychological pain therapy and among the available methods of psychological intervention, mindfulness-based interventions (MBI) are of particular interest. MBI appears to be particularly relevant for pain, as mindfulness focuses, through different meditation exercises, on concentrating attention on here-and-now experiences and supporting new ways of addressing physical sensations and emotional discomfort, characterized by greater acceptance and openness. MBI has been shown effective in treatment of nonmalignant chronic pain. . Patients seen by all four diagnosis teams at the Oncology Department at AUH are screened for pain (0-10 NRS) in connection with their final consultation with the oncologist. Patients with a pain score of ≥ 4 on one or more of the four pain dimensions questions receive a folder describing MBCT and the treatment plan and are encouraged to contact the MBCT team for more information and scheduling of an interview. If the patient, after initial information either by phone or after the first interview decline the offer to participate, but are willing to be contacted for the purpose of gathering more information about their reasons for not participating, we will send them a brief questionnaire concerning their pain and their reasons for choosing to decline the offer, to complete online. They are also asked to give their permission to collect the same information after three months. All data are collected and registered with REDCap, a high data security project administration system administered by Aarhus University's Clinical Trial Unit. The patients will participate in eight weekly two hour group sessions and will be asked to do an additional 45 minutes of daily training at home. The participants will be asked to record their home training to allow assessment of their adherence to the intervention. The program corresponds to the manualized MBCT program, but with adaptations that take into account the special needs of cancer patients, including somewhat shorter sessions, shorter yoga exercises, and the omission of the all-day session. The sessions include psychoeducation and formalized mindfulness exercises with focus on the participants' here-and-now experience of their pain. The aim of the present project is to evaluate the practical implementation of MBCT, with focus on: 1) the observed effects on pain (primary outcome parameter), 2) effects on quality-of-life (QoL) and on other cancer and cancer-treatment-related late effects associated with pain (secondary outcome parameter), 3) possible barriers for continued participation in the program (drop-out), 4) patient experience and satisfaction with the intervention and its organizational/practical implementation, 5) staff's experience of screening procedure and implementation, and 6) collection of data for use in the evaluation of effects, costs, and savings. For use in the evaluation, the patients complete questionnaires prior to the first session (T1), immediately after the last session (T2), and at a six-month follow-up (T3).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ingeborg Farver-Vestergaard, Ph.D.
  • Phone Number: +4587166154
  • Email: ifarver@psy.au.dk

Study Contact Backup

Study Locations

  • Denmark
    • Jylland
      • Aarhus, Jylland, Denmark, 8000
        • Active, not recruiting
        • Aarhus University
      • Aarhus, Jylland, Denmark, 8000
        • Recruiting
        • Dept of Oncology, Aarhus University Hospital
        • Contact:
          • Ingeborg Farver-Vestergaard, PhD-fellow
          • Phone Number: +4587166154
          • Email: ifarver@psy.au.dk
        • Sub-Investigator:
          • Ingeborg Farver-Vestergaard, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >18 yrs. of age
  • completed primary cancer treatment
  • experiencing moderate to severe pain >4 (11-point NRS)

Exclusion Criteria:

  • incomplete chemotherapy or radiation therapy
  • serious psychiatric diagnoses eg. psychosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MBCT
As patients with significant pain are identified and accept the offer of receiving 'Mindfulness-Based Cognitive Therapy' (MBCT) for pain, they will be consecutively included in groups of 12-20 participants. The patients will participate in eight weekly two hour group sessions and will be asked to do an additional 45 minutes of daily training at home.
Behavioral: Mindfulness-Based Cognitive Therapy
The patients participate in eight weekly group sessions of two hours each and will be asked to do an additional 45 minutes of daily training at home. The participants will be asked to record their home training to allow assessment of their adherence to the intervention. Generally, the program corresponds to the manualized MBCT program, but with adaptations that take into account the special needs of cancer patients, including shorter sessions, shorter yoga exercises and the omission of the all-day session. The sessions include psychoeducation and formalized mindfulness exercises with focus on the participants' here-and-now experience of their pain.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity assessed by NRS
Time Frame: Change in pain intensity from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Pain intensity during the last week is assessed by a 11-point numeric rating scale (NRS), range 0-10. (0=no pain, 10= worst pain ever).
Change in pain intensity from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Pain interference assessed by NRS
Time Frame: Change in pain interference from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Pain interference with daily activities during the last week is assessed by a 11-point numeric rating scale (NRS), range 0-10. (0=no interference, 10=maximal interference).
Change in pain interference from baseline (day 0) to post-intervention (up to 30 weeks after baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain quality assessed by the McGill Pain Questionnaire (SF-MPQ-2)
Time Frame: Change in pain quality from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Pain quality is assessed by the McGill Pain Questionnaire, which consists of 22 items representing different descriptors of pain. Each item is rated based on a 0-10 scale (0=no pain, 10=worst pain ever) during the last week. The questionnaire comprises of four parts, including continuous, intermittent, neuropathic and affective pain.
Change in pain quality from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Pain burden assessed by NRS
Time Frame: Change in pain burden from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Pain burden is assessed by a 11-point numeric rating scale (NRS), range 0-10 "How burdensome have your pain been during the last week" (0=not burdensome, 10=very burdensome).
Change in pain burden from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Cancer-related quality of life assessed by EORTC-QLQ-C30
Time Frame: Change in cancer-related quality of life from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Cancer-related quality of life is assessed with the European Organisation for Research and Treatment of Cancer's quality of life questionnaire (EORTC-QLQ-C30), which consists of 30 items.
Change in cancer-related quality of life from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Health-related quality of life assessed by the EQ-5D-3L
Time Frame: Change in health-related quality of life from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Health-realted quality of life is assessed by the EQ-5D, which consists of 5 items, measuring five dimensions of health status: mobility, self-case, usual activities, apin/discomfort, anxiety/depression. Each item is rated by marking a statement representing values at three levels 1-3. Higher scores indicate lower levels of quality of life.
Change in health-related quality of life from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Well-being assessed by the WHO-5
Time Frame: Change in well-being from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Well-being is assessed by the World Health Organization Well-Being Index (WHO-5), which consists of 5 items. Each item is rated on a 6-point Likert scale, ranging from 0-5. Higher scores indicate higher levels of well-being.
Change in well-being from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Fear of cancer recurrence assessed by the FCRI-SF
Time Frame: Change in fear of cancer recurrence from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Fear of cancer recurrence is assessed with the Fear of Cancer Recurrence Inventory - Short Form (FCRI-SF), which consists of 9 items. Each item is rated on a 5-point Likert scale, ranging from 0-4. Higher scores indicate higher levels of fear of cancer recurrence.
Change in fear of cancer recurrence from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Symptoms of depression assessed by the BDI
Time Frame: Change in depression symptoms from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Depressive symptoms are assessed by the Beck Depression Index (BDI), which consists of 21 items. Each item is rated by marking a statement representing values from 0-3. Higher scores indicate higher levels of depression symptoms.
Change in depression symptoms from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Sleep quality assessed by the ISI
Time Frame: Change in sleep quality from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Sleep difficulties are assessed by the Insomnia Severity Index (ISI), which consists of 7 items. Each item is rated on a 5-point Likert scale, ranging from 0-4. Higher scores indicate higher severity of insomnia.
Change in sleep quality from baseline (day 0) to post-intervention (up to 30 weeks after baseline)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain catastrophizing assessed by the PCS
Time Frame: Session-by-session change in pain catastrophizing from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Pain catastrophizing is assessed by the Pain Catastrophizing Scale (PCS), which consists of 13 items. Each item is rated on a 5-point Likert scale (0=not at all, 4=all the time). Higher scores indicate higher levels of pain catastrophizing.
Session-by-session change in pain catastrophizing from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Experiential avoidance assessed by the BEAQ
Time Frame: Session-by-sessions change in experiential avoidance from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Experiential avoidance is assessed by the Brief Experiential Avoidance Questionnaire (BEAQ), which consists of 15 items. Each item is rated on a 6-point Likert scale, ranging from 1=strongly disagreee to 6=strongly agree. Higher scores indicate higher levels of experiential avoidance.
Session-by-sessions change in experiential avoidance from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Mindfulness assessed by the FFMQ
Time Frame: Session-by-session change in mindfulness from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Mindfulness is assessed by the Five Facet Mindfulness Questionnaire (FFMQ), which consists of 39 items. The questionnaire measures five mindfulness facets: acting with awareness, describing, nonjudging of inner experience, nonreactivity to inner experience, observing. Each item is rated on a 5-point Likert scale (1=never or rarely true, 5=very often or always true). Higher scores indicate higher levels of mindfulness.
Session-by-session change in mindfulness from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Self-compassion assessed by the SCS
Time Frame: Session-by-session change in self-compassion from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Self-compassion is assessed by The Self-Compassion Scale - Short form (SCS-SF), which consists of 12 items. Each item is rated on a 5-point Likert scale (1=almost never, 5=almost always). Higher scores indicate higher levels of self-compassion.
Session-by-session change in self-compassion from baseline (day 0) to post-intervention (up to 30 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aarhus University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Zachariae, DMSCi, University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MBCT-late effects 2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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