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ClinicalTrials.gov ID

NCT07497802

Lead Sponsor

Ondokuz Mayıs UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

96Estimated

Last Update Posted

Mar 27, 2026Actual

Start Date

Apr 1, 2026Estimated

Primary Completion Date

Mar 1, 2030Estimated

Completion Date

Aug 1, 2030Estimated

Official 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

Brief Summary

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.

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.

• Gynecologic Cancers

• Mindfulness-Based Psychoeducation Program
• Usual Care

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Ondokuz Mayıs UniversityOTHER

gulcan.demirci@omu.edu.tr+903623121919