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NCT Number: NCT07497802

Mindfulness-Based Psychoeducation for Women With Gynecological Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis University Health Practice and Research Center, Samsun, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mindfulness-based psychoeducation program

Behavioral

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.

Usual Care

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gulcan Demirci, MSc

CONTACT

[email protected]

+903623121919

Zeliha Koc, PhD

CONTACT

[email protected]

+903623121919

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Acronym: MIND-GYN

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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