Clinical trial NCT03591237: MBCT for Cancer Patients in Follow-Up
Official title: Mindfulness-based Cognitive Therapy for Pain in Cancer Patients After Primary Treatment: An Open Implementation Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Management
Keywords: cancer
late effects
pain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2018-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Pain intensity assessed by NRS
timeFrame: Change in pain intensity from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
measure: Pain interference assessed by NRS
timeFrame: Change in pain interference from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Secondary outcomes:
measure: Pain quality assessed by the McGill Pain Questionnaire (SF-MPQ-2)
timeFrame: Change in pain quality from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
measure: Pain burden assessed by NRS
timeFrame: Change in pain burden from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
measure: Cancer-related quality of life assessed by EORTC-QLQ-C30
timeFrame: Change in cancer-related quality of life from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
measure: Health-related quality of life assessed by the EQ-5D-3L
timeFrame: Change in health-related quality of life from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
measure: Well-being assessed by the WHO-5
timeFrame: Change in well-being from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
measure: Fear of cancer recurrence assessed by the FCRI-SF
timeFrame: Change in fear of cancer recurrence from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
measure: Symptoms of depression assessed by the BDI
timeFrame: Change in depression symptoms from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
measure: Sleep quality assessed by the ISI
timeFrame: Change in sleep quality from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Other outcomes:
measure: Pain catastrophizing assessed by the PCS
timeFrame: Session-by-session change in pain catastrophizing from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
measure: Experiential avoidance assessed by the BEAQ
timeFrame: Session-by-sessions change in experiential avoidance from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
measure: Mindfulness assessed by the FFMQ
timeFrame: Session-by-session change in mindfulness from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
measure: Self-compassion assessed by the SCS
timeFrame: Session-by-session change in self-compassion from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
state: Jylland
city: Aarhus
country: Denmark
facility: Dept of Oncology, Aarhus University Hospital
state: Jylland
Study officials:
affiliation: University of Aarhus
name: Robert Zachariae, DMSCi
role: PRINCIPAL_INVESTIGATOR
References: