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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: mindfulness based stress reduction program

• Registration Number: NCT01074528
• Lead Sponsor: Belgian Federal Public Service, Food Chain Safety and Environment

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.

Study Timeline

• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-23
• Study First Posted: 2010-02-24
• Study Start: 2010-04
• Primary Completion: 2017-04
• Study Completion: 2017-05
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mindfulness based stress reduction	mindfulness based stress reduction program	8-week mindfulness based stress reduction program

Primary Outcome Measures

Name	Time	Method
Quality of life (FACT) after training	day 48
quality of life (FACT) before training	day 1

Secondary Outcome Measures

Name	Time	Method
Cancer Coping Questionnaire (CCQ)	day 48
Profile Of Mood Scale (POMS)	day 1
Profile of Mood Scale (POMS)	day 48
Freiburg Mindfulness Inventory (FMI)	day48
Perceived Stress Scale (PSS)	day 48
Freiburg Mindfulness Scale	day 1

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Brussel, Belgium