MBCT for Cancer Patients in Follow-Up

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: Unknown
• Conditions: Pain Management
• Intervention / Treatment: Behavioral: Mindfulness-Based Cognitive Therapy

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: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ingeborg Farver-Vestergaard, Ph.D.; Phone Number: +4587166154; Email: ifarver@psy.au.dk
• Study Contact Backup: Name: Maja Johannsen, Ph.D.; Phone Number: +4587165956; Email: majajo@psy.au.dk

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Pain intensity assessed by NRS	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	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

Outcome Measure	Measure Description	Time Frame
Pain quality assessed by the McGill Pain Questionnaire (SF-MPQ-2)	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	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	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Pain catastrophizing assessed by the PCS	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	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	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	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

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Robert Zachariae, DMSCi, University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: July 6, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 24, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: pain; cancer; late effects
• Other Study ID 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