Cervical DysplasiaPhase 4NCT00842738
Can Alternative Treatment Have an Impact on Cervical Dysplasia?
A Phase 4 study testing Mindfulness meditation and No meditation in people with Cervical Dysplasia, run by University of Copenhagen at 1 site in Denmark.
Trial summary
In this study two questions will be answered: can mindfulness meditation help cell-changed on the cervix to disappear? can mindfulness meditation lower the psychological distress when women have abnormal cervical cancer screening results? Read more about this study
- Who is it for?
- Ages 23 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Dysplasia
- What is being tested?
- Mindfulness meditation and No meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2009to Dec 2011
- Phase
- Phase 4
- 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 23 to 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 23-29 years
- Participated in cervical cancer screening
- Having mild dysplasia and normal screening results
Who cannot join
- Women who have previously had dysplasia
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department and Research Unit of General Practice, Institute of Public Health
Copenhagen, 1014
About this study
Official title: Can Mindfulness Meditation Limit the Progression and/or Increase the Remission of Cervical Dysplasia?
In this study two questions will be answered:
- can mindfulness meditation help cell-changed on the cervix to disappear?
- can mindfulness meditation lower the psychological distress when women have abnormal cervical cancer screening results?
Read the detailed description
200 women, who have participated in cervical cancer screening and have mild dysplasia, will be randomized into two groups; an intervention group and a control group. The intervention group will be asked to do mindfulness meditation twice a week listening to instructions from a CD. 200 additional women having normal cervical screening results will also be included in the project.
- Conditions
- Cervical Dysplasia
- Being tested
- Mindfulness meditation, No meditation, Controls
- Keywords
- Screening, Cervical cancer, Cervical dysplasia, Adverse psychosocial effects, Alternative treatment
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationBehavioural
Mindfulness meditation
No meditationOther
Health care services as usual
ControlsOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness meditation | Active comparator | Women with mild dysplasia offered mindfulness meditation Receives: Behavioral: Mindfulness meditation |
| No meditation | Other | Women with mild dysplasia offered health care services as usual Receives: Other: No meditation |
| Controls | Other | Women with normal cervical cells Receives: Other: Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of cervical dysplasia
Measured: 6 months after screening
Secondary outcomes (1)
Psychosocial consequences measured with the COS-CC questionnaire
Measured: 1 week, 3 and 9 months after screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DysplasiaStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842738
- Sponsor's protocol ID
- UP05010
- Status last verified
- Feb 2009
- First submitted
- 10 Feb 2009
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Mindfulness Meditation Limit the Progression and/or Increase the Remission of Cervical Dysplasia?
- ClinicalTrials.gov ID
- NCT00842738
- Acronym / sponsor ID
- UP05010
- Conditions
- Cervical Dysplasia
- Keywords
- Screening, Cervical cancer, Cervical dysplasia, Adverse psychosocial effects, Alternative treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- Mar 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 12 Feb 2009 (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.
In this study two questions will be answered:
- can mindfulness meditation help cell-changed on the cervix to disappear?
- can mindfulness meditation lower the psychological distress when women have abnormal cervical cancer screening results?
Detailed description
200 women, who have participated in cervical cancer screening and have mild dysplasia, will be randomized into two groups; an intervention group and a control group. The intervention group will be asked to do mindfulness meditation twice a week listening to instructions from a CD. 200 additional women having normal cervical screening results will also be included in the project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness meditation | Active comparator | Behavioral: Mindfulness meditationWomen with mild dysplasia offered mindfulness meditation |
| No meditation | Other | Other: No meditationWomen with mild dysplasia offered health care services as usual |
| Controls | Other | Other: ControlsWomen with normal cervical cells |
Who may qualify
- Ages
- 23 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 23-29 years
- Participated in cervical cancer screening
- Having mild dysplasia and normal screening results
Key exclusion criteria (1 listed)
- Women who have previously had dysplasia
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 meditationMindfulness meditation | Behavioural | Mindfulness meditation |
| No meditationHealth care services as usual | Other | No meditation |
| ControlsNo intervention | Other | Controls |
Primary outcome
The degree of cervical dysplasia
Time frame: 6 months after screening
1 secondary outcome
Psychosocial consequences measured with the COS-CC questionnaire
Time frame: 1 week, 3 and 9 months after screening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
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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 Phase 4 study testing Mindfulness meditation and No meditation in people with Cervical Dysplasia, run by University of Copenhagen at 1 site in Denmark.
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 3 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: status not confirmed, as of the sponsor's last update on 14 Jan 2010. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The degree of cervical dysplasia (time frame: 6 months after screening). 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 14 Jan 2010.