Mindfulness-Based Psychoeducation for Women With Gynecological Cancer

NCT07497802 | Not Yet Recruiting

• 1 other identifier: 2025/452
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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.

Conditions

Gynecologic Cancers

Keywords

Gynecologic Cancer; Mindfulness; Psychoeducation; Hope; Cancer Coping; Quality of Life; Psychological Well-Being

Outcome Measures

Primary Outcomes (4)

• Hopelessness Measured by Beck Hopelessness Scale

  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

  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

  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

  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

Study Arms (2)

Mindfulness-Based Psychoeducation

EXPERIMENTAL

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

Usual Care

OTHER

Usual Care

Behavioral: Usual Care

Interventions

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.

Mindfulness-Based Psychoeducation

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (2)

Ondokuz Mayis University Health Practice and Research Center

Samsun, 55139, Turkey (Türkiye)

Location

Samsun City Hospital

Samsun, 55139, Turkey (Türkiye)

Location

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Zeliha Koc, PhD

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gulcan Demirci, MSc

CONTACT

+903623121919; gulcan.demirci@omu.edu.tr

Zeliha Koc, PhD

CONTACT

+903623121919; zkoc@omu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: Participants diagnosed with gynecological cancer will be randomly assigned to either an intervention group or a control group. The intervention group will receive an 8-week mindfulness-based psychoeducation program delivered in small groups of approximately 4-5 participants through online sessions guided by the researcher. The control group will receive usual care. Outcome measurements will be conducted at baseline, immediately after the intervention, and at 3- and 6-month follow-up.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)