NeoplasmsSASONCT01303822
Mindfulness-based Stress Reduction in Cancer Treatment
A study testing Mindfulness-based day-care clinic group program in people with Neoplasms, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
Emotional and mental symptoms are common consequences of cancer diagnosis and treatment. Coping with these symptoms seems to be influenced by interpretation of illness, locus of health control and spiritual attitudes in dealing with illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Mindfulness-based day-care clinic group program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Jun 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cancer
- Physical and mental ability to participate in the program
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine
Essen, North Rhine-Westphalia, 45276
About this study
Official title: Mindfulness-based Stress Reduction in Supportive Cancer Treatment: Effects of a Day-care Clinic Group Program on Psychometric Parameters in Cancer Patients (Stressbewältigung Durch Achtsamkeit in Der Supportiven Onkologischen Therapie (SASO): Auswirkung Eines Tagesklinischen Gruppenprogramms Auf Psychometrische Parameter Bei Krebspatienten)
Emotional and mental symptoms are common consequences of cancer diagnosis and treatment. Coping with these symptoms seems to be influenced by interpretation of illness, locus of health control and spiritual attitudes in dealing with illness.
Mindfulness-based stress reduction has been shown to reduce physical and mental symptoms in cancer patients.
The aim of this study is to investigate the effect of a mindfulness-based day-care clinic group program on quality of life, anxiety and depression in cancer patients and to evaluate the association with coping styles, spiritual attitudes in dealing with illness, mindfulness and interpretation of illness.
- Conditions
- Neoplasms
- Being tested
- Mindfulness-based day-care clinic group program
- 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 day-care clinic group programBehavioural
11 weeks of mindfulness-based day-care clinic group program. 6 hours per week.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based day-care clinic group program | Experimental | 11 weeks of mindfulness-based day-care clinic group program. 6 hours per week. Receives: Behavioral: Mindfulness-based day-care clinic group program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
Reference: Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Psychosom Med. 2003;65:571-581.
Measured: Week 11
Secondary outcomes (7)
Health-related quality of life
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
Reference: Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Psychosom Med. 2003;65:571-581.
Measured: Week 32
Anxiety and depression
Hospital Anxiety and Depression Score (HADS)
Measured: Week 11; week 32
Life satisfaction
Brief Multidimensional Life Satisfaction Scale (BMLSS).
Reference: Büssing A, Fischer J. Interpretation of illness in cancer survivors is associated with healthrelated variables and adaptive coping styles. BMC Womens Health. 2009;9:2.
Measured: Week 11; week 32
Mindfulness
Freiburg Mindfulness Inventory (FMI). Reference:Walach H, Buchheld N, Buttenmüller V, Kleinknecht N, Grossmann P, Schmidt S (2003). Empirische Erfassung der Achtsamkeit - Die Konstruktion des Freiburger Fragebogen zur Achtsamkeit (FFA) und weitere Validierungsstudien. In Heidenreich T, Michalak J: Achtsamkeit und Akzeptanz in der Psychotherapie, dgvt-Verlag.
Measured: Week 11; week 32
Adaptive coping styles
AKU questionnaire.
Reference: Büssing A, Fischer J. Interpretation of illness in cancer survivors is associated with healthrelated variables and adaptive coping styles. BMC Womens Health. 2009;9:2.
Measured: Week 11; week 32
Spiritual and religious attitudes in dealing with illness
SpREUK questionnaire.
Reference: Büssing A. Spirituality as a resource to rely on in chronic illness: the SpREUK questionnaire. Religions 2010;1:9-17.
Measured: Week 11; week 32
Interpretation of illness
Interpretation of Illness Questionnaires (IIQ).
Reference: Büssing A, Fischer J. Interpretation of illness in cancer survivors is associated with healthrelated variables and adaptive coping styles. BMC Womens Health. 2009;9:2.
Measured: Week 11; week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holger Cramer, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303822
- Sponsor's protocol ID
- 11-4600
- Acronym
- SASO
- Status last verified
- Jul 2013
- First submitted
- 24 Feb 2011
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Stress Reduction in Supportive Cancer Treatment: Effects of a Day-care Clinic Group Program on Psychometric Parameters in Cancer Patients (Stressbewältigung Durch Achtsamkeit in Der Supportiven Onkologischen Therapie (SASO): Auswirkung Eines Tagesklinischen Gruppenprogramms Auf Psychometrische Parameter Bei Krebspatienten)
- ClinicalTrials.gov ID
- NCT01303822
- Acronym / sponsor ID
- SASO / 11-4600
- Conditions
- Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 Feb 2011 (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.
Emotional and mental symptoms are common consequences of cancer diagnosis and treatment. Coping with these symptoms seems to be influenced by interpretation of illness, locus of health control and spiritual attitudes in dealing with illness.
Mindfulness-based stress reduction has been shown to reduce physical and mental symptoms in cancer patients.
The aim of this study is to investigate the effect of a mindfulness-based day-care clinic group program on quality of life, anxiety and depression in cancer patients and to evaluate the association with coping styles, spiritual attitudes in dealing with illness, mindfulness and interpretation of illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based day-care clinic group program | Experimental | Behavioral: Mindfulness-based day-care clinic group program11 weeks of mindfulness-based day-care clinic group program. 6 hours per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of cancer
- Physical and mental ability to participate in the program
Key exclusion criteria (1 listed)
- Pregnancy
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 day-care clinic group program11 weeks of mindfulness-based day-care clinic group program. 6 hours per week. | Behavioural | Mindfulness-based day-care clinic group program |
Primary outcome
Health-related quality of life
Time frame: Week 11
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Reference: Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Psychosom Med. 2003;65:571-581.
7 secondary outcomes
Health-related quality of life
Time frame: Week 32
Anxiety and depression
Time frame: Week 11; week 32
Life satisfaction
Time frame: Week 11; week 32
Mindfulness
Time frame: Week 11; week 32
Adaptive coping styles
Time frame: Week 11; week 32
Spiritual and religious attitudes in dealing with illness
Time frame: Week 11; week 32
Interpretation of illness
Time frame: Week 11; week 32
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 24 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 day-care clinic group program in people with Neoplasms, run by Universität Duisburg-Essen at 1 site in Germany.
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 2 inclusion and 1 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 24 Jul 2013. 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 Germany. 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?
Health-related quality of life (time frame: Week 11). 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 24 Jul 2013.