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Completed

NCT Number: NCT01074528

Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel

Brussels, 1090, Belgium

About this study

Patients with breast cancer often experience anxiety, depression, stress and reduced quality of life. As such, there is an increased interest in the implementation of the Mindfulness-Based Stress Reduction program as an additional supportive treatment. MBSR is a structured group program that aims at reducing stress levels by enhancing awareness of the present moment in combination with a non-judgemental attitude.

The study evaluates the effects of an 8-week MBSR program on quality of life, mood, depression, stress and coping skills in breast cancer patients.

Breast cancer patients of the Breast Clinic of the Universitair Ziekenhuis Brussel participate in the MBSR program. Before and after the training program patients filled out questionnaires evaluating quality of life, coping skills, emotional functioning, stress and aspects of mindfulness.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For patients:

  • Cancer diagnosis
  • Between the age of 18 until 70
  • Dutch speaking

For partners:

  • between the age of 18 until 70
  • dutch speaking

Exclusion criteria

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

Treatment and study plan

Mindfulness based stress reduction program

Behavioral

8-week mindfulness training program

Other names: MBSR

Primary outcomes

  1. quality of life (FACT) before training

    Time frame: day 1

  2. Quality of life (FACT) after training

    Time frame: day 48

Secondary outcomes

  1. Cancer Coping Questionnaire (CCQ)

    Time frame: day 1

  2. Profile Of Mood Scale (POMS)

    Time frame: day 1

  3. Perceived Stress Scale (PSS)

    Time frame: day 1

  4. Freiburg Mindfulness Scale

    Time frame: day 1

  5. Cancer Coping Questionnaire (CCQ)

    Time frame: day 48

  6. Profile of Mood Scale (POMS)

    Time frame: day 48

  7. Perceived Stress Scale (PSS)

    Time frame: day 48

  8. Freiburg Mindfulness Inventory (FMI)

    Time frame: day48

Sponsors and collaborators

Lead sponsor

Belgian Federal Public Service, Food Chain Safety and Environment

Other Gov

Registry information

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Feb 24, 2010
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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