NCT01074528

Brief Summary

The main purpose of this study is to evaluate the effects of the Mindfulness Based Stress Reduction (MBSR) training program that is offered in the investigator hospital, more specifically on quality of life, coping strategies and partner relationship by using questionnaires. To asses the possible impact of this treatment on the latter domain, partners of the patients with a cancer diagnosis are invited to join the training program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

7 years

First QC Date

February 18, 2010

Last Update Submit

July 13, 2017

Conditions

Cancer

Keywords

cancer patientsrelatives or partners of cancer patients

Outcome Measures

Primary Outcomes (2)

  • quality of life (FACT) before training

    day 1

  • Quality of life (FACT) after training

    day 48

Secondary Outcomes (8)

  • Cancer Coping Questionnaire (CCQ)

    day 1

  • Profile Of Mood Scale (POMS)

    day 1

  • Perceived Stress Scale (PSS)

    day 1

  • Freiburg Mindfulness Scale

    day 1

  • Cancer Coping Questionnaire (CCQ)

    day 48

  • +3 more secondary outcomes

Study Arms (2)

mindfulness based stress reduction

EXPERIMENTAL

8-week mindfulness based stress reduction program

Behavioral: mindfulness based stress reduction program

control group

NO INTERVENTION

patients who have to wait before entering the MBSR program or who do not want to follow this program

Interventions

mindfulness based stress reduction programBEHAVIORAL

8-week mindfulness training program

Also known as: MBSR
mindfulness based stress reduction

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For patients:
  • Cancer diagnosis
  • Between the age of 18 until 70
  • Dutch speaking
  • For partners:
  • between the age of 18 until 70
  • dutch speaking

You may not qualify if:

  • for patients and partners:
  • Ongoing radiation therapy
  • Psychiatric disorders
  • Previous experience with mindfulness or meditation related techniques
  • Pregnancy
  • No or insufficient understanding of the Dutch language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Christiaan Schotte, PhD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 24, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

July 17, 2017

Record last verified: 2017-07

Locations

BE(1)