Early Mindfulness Based Cognitive Therapy for Prevention... | NCT07124481

Studies
Early Mindfulness Based Cognitive Therapy for Prevention of Psychological Distress in Cancer Patients

NCT07124481

Sponsor

Isala

Status

Not yet recruiting

Last Update Posted

Aug 15, 2025Actual

Enrollment

208Estimated

Phase

Not Applicable

Conditions

Cancer
Mindfulness Based Cognitive Therapy

Interventions

Mindfulness based stress reduction

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2025Estimated

Primary Completion Date

Oct 2027Estimated

Completion Date

Oct 2027Estimated

First Submitted Date

Aug 8, 2025

First Submission Date that Met QC Criteria

Aug 8, 2025

First Posted Date

Aug 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2025

Last Update Posted Date

Aug 15, 2025Actual

Name	Class
Helen Dowling Institute	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

208Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	mindfulness based stress reduction	Behavioral: Mindfulness based stress reduction
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness based stress reduction	Behavioral	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Psychological distress	Anxiety and depression as measured with the Hospital Anxiety and Depression Scale	From enrollment to 2 years after diagnosis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marit Mentink, PhD	Contact	+31657643188		m.d.c.mentink@isala.nl
Eva Noorda, PhD	Contact			evanoorda@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000099024	Mindfulness-Based Stress Reduction
D064866	Mindfulness

Ancestor Terms

ID	Term
D015928	Cognitive Behavioral Therapy
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided