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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074528
• Other study ID #: SCV2010
• Status: Completed
• Phase: N/A
• First received: February 18, 2010
• Last updated: July 13, 2017
• Start date: April 2010
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• Source: Belgian Federal Public Service, Food Chain Safety and Environment
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• mindfulness based stress reduction program
8-week mindfulness training program

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Belgian Federal Public Service, Food Chain Safety and Environment

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life (FACT) before training		day 1
Primary	Quality of life (FACT) after training		day 48
Secondary	Cancer Coping Questionnaire (CCQ)		day 1
Secondary	Profile Of Mood Scale (POMS)		day 1
Secondary	Perceived Stress Scale (PSS)		day 1
Secondary	Freiburg Mindfulness Scale		day 1
Secondary	Cancer Coping Questionnaire (CCQ)		day 48
Secondary	Profile of Mood Scale (POMS)		day 48
Secondary	Perceived Stress Scale (PSS)		day 48
Secondary	Freiburg Mindfulness Inventory (FMI)		day48