MBCT for Cancer Patients in Follow-Up

NCT03591237 | Unknown DMC

• 1 other identifier: MBCT-late effects 2018
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain Management

Keywords

cancer; late effects; pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Pain quality assessed by the McGill Pain Questionnaire (SF-MPQ-2)

  Change in pain quality from baseline (day 0) to post-intervention (up to 30 weeks after baseline)

• Pain burden assessed by NRS

  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

  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

  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

  Change in well-being from baseline (day 0) to post-intervention (up to 30 weeks after baseline)

Other Outcomes (4)

• Pain catastrophizing assessed by the PCS

  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

  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

  Session-by-session change in mindfulness from baseline (day 0) to post-intervention (up to 30 weeks after baseline)

Study Arms (1)

MBCT

EXPERIMENTAL

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

Interventions

Mindfulness-Based Cognitive Therapy 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.

MBCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (2)

Aarhus University

Aarhus, Jylland, 8000, Denmark

ACTIVE NOT RECRUITING

Dept of Oncology, Aarhus University Hospital

Aarhus, Jylland, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Agnosia; Neoplasms; Pain

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Robert Zachariae, DMSCi

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingeborg Farver-Vestergaard, Ph.D.

CONTACT

+4587166154; ifarver@psy.au.dk

Maja Johannsen, Ph.D.

CONTACT

+4587165956; majajo@psy.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: July 19, 2018
• Study Start: March 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: March 1, 2020
• Last Updated: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)