CancerNCT01074528
Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners
A study testing mindfulness based stress reduction program in people with Cancer, run by Belgian Federal Public Service, Food Chain Safety and Environment at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer
- What is being tested?
- mindfulness based stress reduction program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2010to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For patients:
- Cancer diagnosis
- Between the age of 18 until 70
- Dutch speaking
- For partners:
- between the age of 18 until 70
- dutch speaking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- mindfulness based stress reduction program
- Keywords
- cancer patients, relatives or partners of cancer patients
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness based stress reduction programBehavioural
Also called MBSR
8-week mindfulness training program
| Study group | Role | What they receive |
|---|---|---|
| mindfulness based stress reduction | Experimental | 8-week mindfulness based stress reduction program Receives: Behavioral: mindfulness based stress reduction program |
| control group | No intervention | patients who have to wait before entering the MBSR program or who do not want to follow this program |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life (FACT) before training
Measured: day 1
Quality of life (FACT) after training
Measured: day 48
Secondary outcomes (8)
Cancer Coping Questionnaire (CCQ)
Measured: day 1
Profile Of Mood Scale (POMS)
Measured: day 1
Perceived Stress Scale (PSS)
Measured: day 1
Freiburg Mindfulness Scale
Measured: day 1
Cancer Coping Questionnaire (CCQ)
Measured: day 48
Profile of Mood Scale (POMS)
Measured: day 48
Perceived Stress Scale (PSS)
Measured: day 48
Freiburg Mindfulness Inventory (FMI)
Measured: day48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belgian Federal Public Service, Food Chain Safety and Environment
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Dr. Christiaan Schotte, Belgian Federal Public Service, Food Chain Safety and Environment
- Investigators
- Christiaan Schotte, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074528
- Sponsor's protocol ID
- SCV2010
- Status last verified
- Jul 2017
- First submitted
- 18 Feb 2010
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners
- ClinicalTrials.gov ID
- NCT01074528
- Acronym / sponsor ID
- SCV2010
- Conditions
- Cancer
- Keywords
- cancer patients, relatives or partners of cancer patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Belgian Federal Public Service, Food Chain Safety and EnvironmentOther government
- Study start
- Apr 2010
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mindfulness based stress reduction | Experimental | Behavioral: mindfulness based stress reduction program8-week mindfulness based stress reduction program |
| control group | No intervention | –patients who have to wait before entering the MBSR program or who do not want to follow this program |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cancer diagnosis
- Between the age of 18 until 70
- Dutch speaking
- between the age of 18 until 70
- dutch speaking
Key exclusion criteria (6 listed)
- Ongoing radiation therapy
- Psychiatric disorders
- Previous experience with mindfulness or meditation related techniques
- Pregnancy
- No or insufficient understanding of the Dutch language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness based stress reduction programAlso: MBSR8-week mindfulness training program | Behavioural | mindfulness based stress reduction |
Primary outcome
quality of life (FACT) before training
Time frame: day 1
Quality of life (FACT) after training
Time frame: day 48
8 secondary outcomes
Cancer Coping Questionnaire (CCQ)
Time frame: day 1
Profile Of Mood Scale (POMS)
Time frame: day 1
Perceived Stress Scale (PSS)
Time frame: day 1
Freiburg Mindfulness Scale
Time frame: day 1
Cancer Coping Questionnaire (CCQ)
Time frame: day 48
Profile of Mood Scale (POMS)
Time frame: day 48
Perceived Stress Scale (PSS)
Time frame: day 48
Freiburg Mindfulness Inventory (FMI)
Time frame: day48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiaan Schotte, PhD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness based stress reduction program in people with Cancer, run by Belgian Federal Public Service, Food Chain Safety and Environment at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life (FACT) before training (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.