CancerEarlyMindNCT07124481
Early Mindfulness Based Cognitive Therapy for Prevention of Psychological Distress in Cancer Patients
A study testing Mindfulness based stress reduction in people with Cancer and Mindfulness Based Cognitive Therapy, run by Isala.
Trial summary
The goal of this clinical trial is to learn if early provision of mindfulness based cognitive therapy can prevent psychological distress in adult patients with cancer one year after diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Mindfulness Based Cognitive Therapy
- What is being tested?
- Mindfulness based stress reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosed with urological cancer or breast cancer
- <6 weeks since cancer diagnosis
- Planned curative treatment or palliative treatment with life expectation >1 year
- Good proficiency in Dutch language
Who cannot join
- Serious psychiatric history or current psychiatric treatment (interfering with study participation): 1) current suicidal ideation, 2) current psychosis or bipolar disorder, 3) psychosis or bipolar disorder in history
- Unable to understand study procedure
- A priori unable to be available for 8 week MBCT
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Eva Noorda, PhD contact
About this study
The goal of this clinical trial is to learn if early provision of mindfulness based cognitive therapy can prevent psychological distress in adult patients with cancer one year after diagnosis.
Researchers will compare mindfulness based cognitive therapy to usual care to see if psychological distress is lower in patients that followed mindfulness.
Participants will follow 8 weekly sessions of mindfulness and fill in questionnaires.
- Conditions
- Cancer, Mindfulness Based Cognitive Therapy
- Being tested
- Mindfulness based stress reduction
- 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 reductionBehavioural
Also called mindfulness, mindfulness therapy, MBCT
8 weekly sessions of 2.5 hour per session, face-to-face in a group consisting of maximum 15 participants, supervised by a certified mindfulness trainer
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | mindfulness based stress reduction Receives: Behavioral: Mindfulness based stress reduction |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological distress
Anxiety and depression as measured with the Hospital Anxiety and Depression Scale
Measured: From enrollment to 2 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Collaborators
- Helen Dowling Institute
- Responsible party
- Principal investigator, Marit Mentink, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124481
- Sponsor's protocol ID
- 2306
- Acronym
- EarlyMind
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Mindfulness Based Cognitive Therapy for Prevention of Psychological Distress in Cancer Patients
- ClinicalTrials.gov ID
- NCT07124481
- Acronym / sponsor ID
- EarlyMind / 2306
- Conditions
- Cancer, Mindfulness Based Cognitive Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- IsalaUniversity, hospital or other
- Collaborators
- Helen Dowling Institute
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 15 Aug 2025 (actual)
- 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 goal of this clinical trial is to learn if early provision of mindfulness based cognitive therapy can prevent psychological distress in adult patients with cancer one year after diagnosis.
Researchers will compare mindfulness based cognitive therapy to usual care to see if psychological distress is lower in patients that followed mindfulness.
Participants will follow 8 weekly sessions of mindfulness and fill in questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mindfulness based stress reductionmindfulness based stress reduction |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with urological cancer or breast cancer
- <6 weeks since cancer diagnosis
- Planned curative treatment or palliative treatment with life expectation >1 year
- Good proficiency in Dutch language
Key exclusion criteria (3 listed)
- Serious psychiatric history or current psychiatric treatment (interfering with study participation): 1) current suicidal ideation, 2) current psychosis or bipolar disorder, 3) psychosis or bipolar disorder in history
- Unable to understand study procedure
- A priori unable to be available for 8 week MBCT
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 reductionAlso: mindfulness, mindfulness therapy, MBCT8 weekly sessions of 2.5 hour per session, face-to-face in a group consisting of maximum 15 participants, supervised by a certified mindfulness trainer | Behavioural | Intervention |
Primary outcome
Psychological distress
Time frame: From enrollment to 2 years after diagnosis
Anxiety and depression as measured with the Hospital Anxiety and Depression Scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Eva Noorda, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based stress reduction in people with Cancer and Mindfulness Based Cognitive Therapy, run by Isala.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marit Mentink, PhD (+31657643188, m.d.c.mentink@isala.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress (time frame: From enrollment to 2 years after diagnosis). 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 15 Aug 2025.