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

NCT ID: NCT07124481

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-10-31

Brief Summary

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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

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Conditions

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Cancer Mindfulness Based Cognitive Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

mindfulness based stress reduction

Group Type EXPERIMENTAL

Mindfulness based stress reduction

Intervention Type 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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness based stress reduction

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

Intervention Type BEHAVIORAL

Other Intervention Names

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mindfulness mindfulness therapy MBCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helen Dowling Institute

UNKNOWN

Sponsor Role collaborator

Isala

OTHER

Sponsor Role lead

Responsible Party

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Marit Mentink

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Marit Mentink, PhD

Role: CONTACT

+31657643188

Eva Noorda, PhD

Role: CONTACT

Other Identifiers

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2306

Identifier Type: -

Identifier Source: org_study_id

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