Clinical trial NCT01074528: Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners
Official title: Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: cancer patients
relatives or partners of cancer patients
Lead sponsor: Belgian Federal Public Service, Food Chain Safety and Environment
Sponsor class: OTHER_GOV
First posted: 2010-02-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: quality of life (FACT) before training
timeFrame: day 1
measure: Quality of life (FACT) after training
timeFrame: day 48
Secondary outcomes:
measure: Cancer Coping Questionnaire (CCQ)
timeFrame: day 1
measure: Profile Of Mood Scale (POMS)
timeFrame: day 1
measure: Perceived Stress Scale (PSS)
timeFrame: day 1
measure: Freiburg Mindfulness Scale
timeFrame: day 1
measure: Cancer Coping Questionnaire (CCQ)
timeFrame: day 48
measure: Profile of Mood Scale (POMS)
timeFrame: day 48
measure: Perceived Stress Scale (PSS)
timeFrame: day 48
measure: Freiburg Mindfulness Inventory (FMI)
timeFrame: day48
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Christiaan Schotte, PhD
role: PRINCIPAL_INVESTIGATOR
References: