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

NCT ID: NCT01074528

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2017-05-31

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.

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

mindfulness based stress reduction

8-week mindfulness based stress reduction program

Group Type: EXPERIMENTAL

mindfulness based stress reduction program

Intervention Type: BEHAVIORAL

8-week mindfulness training program

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mindfulness based stress reduction program

8-week mindfulness training program

Intervention Type: BEHAVIORAL

Other Intervention Names

MBSR

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Belgian Federal Public Service, Food Chain Safety and Environment

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof. Dr. Christiaan Schotte

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christiaan Schotte, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

UZ Brussel

Brussels, , Belgium

Countries

Belgium

Other Identifiers

SCV2010

Identifier Type: -

Identifier Source: org_study_id