Mindfulness-Based Psychoeducation for Women With Gynecological Cancer (MIND-GYN)

March 23, 2026 updated by: Gülcan Demirci, Ondokuz Mayıs University

Effect of a Mindfulness-Based Psychoeducation Program on Hope, Cognitive-Emotional Coping With Cancer, Quality of Life, and Psychological Well-Being in Women With Gynecological Cancer: A Randomized Controlled Trial

This randomized controlled study aims to evaluate the effect of a mindfulness-based psychoeducation program on hope, cognitive-emotional coping with cancer, quality of life, and psychological well-being in women diagnosed with gynecological cancer. Women receiving treatment for gynecological cancer will be randomly assigned to either an intervention group and a control group. The intervention group will participate in an 8-week mindfulness-based psychoeducation program delivered in small groups via online platforms under the guidance of the researcher. The program will include mindfulness practices such as breathing exercises, body scan, awareness exercises, and guided imagery techniques aimed at improving emotional coping and psychological well-being. The control group will receive usual care. Outcomes will be assessed at baseline, immediately after the intervention, and at 3- and 6-month follow-up assessments.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Gynecological cancers, including cancers of the cervix, ovary, uterus, vulva, vagina, and fallopian tubes, affect women's physical, psychological, and social well-being. Women diagnosed with cancer often experience emotional distress, uncertainty about the future, fear of recurrence, and difficulties coping with the disease and treatment process. These challenges may negatively affect psychological well-being, hope, coping abilities, and quality of life.

Mindfulness-based interventions have increasingly been used to support psychological adjustment and coping among individuals with chronic illnesses, including cancer. Mindfulness focuses on cultivating present-moment awareness in a nonjudgmental manner and helps individuals regulate emotions, reduce stress, and enhance adaptive coping strategies. Evidence from previous studies indicates that mindfulness-based psychoeducational interventions can improve psychological well-being, strengthen coping abilities, and increase hope and quality of life among cancer patients.

This randomized controlled trial aims to evaluate the effectiveness of a mindfulness-based psychoeducation program for women diagnosed with gynecological cancer. Eligible participants receiving inpatient or outpatient treatment will be randomly assigned to an intervention group or a control group. The intervention group will receive an eight-session mindfulness-based psychoeducation program delivered weekly in small groups consisting of approximately four to five participants. Sessions will be conducted online via secure videoconferencing platforms and will be guided by the researcher.

Data will be collected at four time points: baseline (before the intervention), immediately after the intervention, and at three-month and six-month follow-ups. The findings of this study are expected to contribute to the development of supportive psychosocial interventions aimed at improving hope, coping with cancer, quality of life, and psychological well-being among women with gynecological cancer.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Samsun, Turkey (Türkiye), 55139
      • Samsun, Turkey (Türkiye), 55139
        • Ondokuz Mayis University Health Practice and Research Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women who voluntarily agree to participate in the study
  • Women aged 18 years and older
  • Women diagnosed with gynecological cancer and currently undergoing active treatment (e.g., surgery, chemotherapy, radiotherapy, immunotherapy, or targeted therapy)
  • Ability to participate in online sessions from home after hospital discharge
  • Ability to use a smartphone or similar device to access online sessions
  • Having at least basic literacy (able to read and write)
  • Expected life expectancy ≥ 12 months, as evaluated by the responsible oncologist

Exclusion Criteria:

  • Diagnosis of a psychiatric disorder that may interfere with participation
  • Current use of psychiatric medications
  • Previous participation in Mindfulness-Based Stress Reduction (MBSR) or similar mindfulness programs
  • Having a physical condition that prevents participation in the intervention sessions
  • Presence of communication barriers (e.g., inability to speak Turkish, severe hearing impairment)
  • Having a history of previous cancer diagnosis or metastatic disease
  • Participants who voluntarily withdraw from the study during the intervention period
  • Participation in less than 80% of the intervention sessions (attendance at fewer than 6 out of 8 sessions)
  • Discontinuation of treatment or death during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Usual Care
Behavioral: Usual Care
Participants in the control group will receive usual care provided by the healthcare institution and will not participate in the mindfulness-based psychoeducation program during the study period.
Experimental: Mindfulness-Based Psychoeducation
Participants in this group will take part in an eight-week mindfulness-based psychoeducation program conducted in small groups of approximately 4-5 participants. The sessions will be delivered once weekly through online platforms under the guidance of the researcher. The program will include mindfulness practices such as breathing exercises, body scan meditation, awareness exercises, and guided imagery. These practices are intended to enhance participants' sense of hope and quality of life, while also supporting psychological well-being and improving coping with cancer.
Behavioral: Mindfulness-Based Psychoeducation Program
The mindfulness-based psychoeducation program is designed to support psychological well-being and coping with cancer among women diagnosed with gynecological cancer. The program consists of eight weekly sessions conducted in small groups of approximately 4-5 participants and delivered through online platforms under the guidance of the researcher. The sessions include mindfulness-based practices such as breathing exercises, body scan meditation, awareness exercises, guided imagery, and reflective group discussions. The program aims to enhance participants' awareness of the present moment, improve emotional regulation, strengthen coping with cancer, and promote psychological well-being, hope, and quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hopelessness Measured by Beck Hopelessness Scale
Time Frame: Baseline, immediately after the intervention, 3 months, and 6 months follow-up
Hopelessness will be assessed using the Beck Hopelessness Scale (BHS). The scale measures negative expectations about the future and pessimistic attitudes. Higher scores indicate greater levels of hopelessness among participants.
Baseline, immediately after the intervention, 3 months, and 6 months follow-up
Cognitive-Emotional Coping with Cancer Scale Scores
Time Frame: Baseline, immediately after the intervention, 3 months, and 6 months follow-up
Cognitive-emotional coping with cancer will be assessed using the Cognitive-Emotional Coping with Cancer Scale. Higher scores indicate more adaptive coping strategies among women diagnosed with gynecological cancer.
Baseline, immediately after the intervention, 3 months, and 6 months follow-up
Quality of Life Measured by EORTC QLQ-C30
Time Frame: Baseline, immediately after the 8-week intervention, 3 months, and 6 months after the intervention
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Higher scores on functional scales indicate better quality of life among women diagnosed with gynecological cancer.
Baseline, immediately after the 8-week intervention, 3 months, and 6 months after the intervention
Psychological Well-Being Measured by the Psychological Well-Being Scale
Time Frame: Baseline, immediately after the 8-week intervention, 3 months, and 6 months after the intervention
Psychological well-being will be assessed using the Psychological Well-Being Scale. Higher scores indicate better psychological well-being among women diagnosed with gynecological cancer.
Baseline, immediately after the 8-week intervention, 3 months, and 6 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Investigators

  • Principal Investigator: Zeliha Koc, PhD, Ondokuz Mayıs University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Mindfulness-based interventions for cancer patients have been widely studied and shown to improve psychological well-being, coping, and quality of life.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/452

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data collected during this study will not be publicly shared due to privacy and confidentiality considerations related to patient data. The data will be used solely for the purposes of the present research and academic thesis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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