MBCT for Cancer Patients in Follow-Up

NCT ID: NCT03591237

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-03-01

Brief Summary

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.

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).

Conditions

Pain Management

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness-Based Cognitive Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Zachariae, DMSCi

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

Aarhus University

Aarhus, Jylland, Denmark

Site Status: ACTIVE_NOT_RECRUITING

Dept of Oncology, Aarhus University Hospital

Aarhus, Jylland, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Ingeborg Farver-Vestergaard, Ph.D.

Role: CONTACT

ifarver@psy.au.dk

+4587166154

Maja Johannsen, Ph.D.

Role: CONTACT

majajo@psy.au.dk

+4587165956

Facility Contacts

Ingeborg Farver-Vestergaard, PhD-fellow

Role: primary

ifarver@psy.au.dk

+4587166154

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MBCT-late effects 2018

Identifier Type: -

Identifier Source: org_study_id