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NCT Number: NCT07284030

Psychoeducation and Well-Being After Breast Cancer

This randomized controlled trial evaluates the effectiveness of a web-based psychoeducation program on psychological well-being and quality of life in breast cancer survivors who completed active treatment at least one year earlier.

Seventy-two women will be randomly assigned to either a 6-week online psychoeducation program plus standard care or standard care alone. The intervention consists of weekly 30-45 minute online sessions focusing on coping strategies, psychosocial adjustment, quality of life, and psychological well-being.

Primary outcomes include psychological well-being, fear of cancer recurrence, quality of life, and hopelessness, assessed at baseline, post-intervention, and 2-month follow-up.

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Key information

Conditions

Breast Cancer Breast - Female Breast Cancer Survivors Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Psycho-Oncology Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Breast Cancer Outpatient Clinic

Istanbul, 34740, Turkey (Türkiye)

Location status: Recruiting

Location contact

Yasemin Nazlı, MSc

CONTACT

[email protected]

+9005325025158

About this study

This randomized controlled study investigates the effects of a structured web-based psychoeducation program on psychological outcomes in breast cancer survivors who have completed active treatment and are in remission for at least one year.

Eligible participants will be randomly allocated to an intervention group or a control group. The intervention group will receive a 6-week web-based psychoeducation program in addition to standard care, while the control group will receive standard care alone. The program is delivered through the online platform www.onkodestek.org and includes weekly live sessions conducted via Zoom, each lasting approximately 30-45 minutes.

The psychoeducation program addresses coping with breast cancer survivorship, psychosocial challenges, enhancement of psychological well-being, improvement of quality of life, and development of hope and meaning in life.

Psychological well-being, fear of cancer recurrence, quality of life, and hopelessness will be assessed at baseline, immediately after the intervention, and at 2-month follow-up using validated self-report measures. After study completion, participants in the control group will be granted access to the psychoeducation platform.

This study aims to assess whether web-based psychoeducation provides measurable psychological benefits for breast cancer survivors during the post-treatment survivorship period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female breast cancer survivors
  • Completed active breast cancer treatment (surgery, chemotherapy, radiotherapy) at least 12 months ago
  • Currently in remission (no evidence of active disease)
  • Age between 18-65 years
  • Able to read and write Turkish
  • Access to computer or smartphone with internet connection
  • Able to participate in online video sessions via Zoom
  • Willing to provide informed consent

Exclusion criteria

  • Current cancer recurrence or metastatic disease
  • Active psychiatric disorder requiring treatment
  • Cognitive impairment that prevents participation in online sessions
  • Currently receiving active cancer treatment (excluding hormonal therapy)
  • Participation in another psychosocial intervention study
  • No internet access or inability to use web-based platforms
  • Male breast cancer patients
  • Unable to commit to 6-week program schedule

Treatment and study plan

Web-Based Psychoeducation Program

Behavioral

Six-week structured psychoeducation program delivered online through www.onkodestek.org website and weekly Zoom sessions. Topics include living with breast cancer, managing psychosocial issues, improving quality of life, psychological well-being, and finding hope and meaning. Each session lasts 30-45 minutes.

Primary outcomes

  1. Change in Psychological Well-Being

    Time frame: Baseline, 6 weeks (post-intervention), and 2-month follow-up

    Measured by the Psychological Well-Being Scale

    Change in psychological well-being measured using the Psychological Well-Being Scale. The scale consists of 8 items rated on a 7-point Likert scale, with total scores ranging from 8 to 56. Higher scores indicate better psychological well-being.

  2. Change in Fear of Cancer Recurrence

    Time frame: Baseline, 6 weeks (post-intervention), and 2-month follow-up

    Measured by the Fear of Cancer Recurrence Inventory

    Change in fear of cancer recurrence measured using the Fear of Cancer Recurrence Inventory. Items are scored on a 5-point Likert scale (0-4), with higher scores indicating greater fear of cancer recurrence.

Secondary outcomes

  1. Change in Cancer-Related Quality of Life

    Time frame: Baseline, 6 weeks, and 2-month follow-up

    Measured by the EORTC QLQ-C30

    Change in cancer-related quality of life assessed using the EORTC QLQ-C30. Scores are transformed to a 0-100 scale. Higher scores indicate better quality of life for functional scales and global health status, and worse symptoms for symptom scales.

  2. Change in Hopelessness

    Time frame: Baseline, 6 weeks, and 2-month follow-up

    Measured by the Beck Hopelessness Scale

    Change in hopelessness measured using the Beck Hopelessness Scale. The scale consists of 20 items with total scores ranging from 0 to 20. Higher scores indicate greater hopelessness.

  3. Change in Breast Cancer-Specific Quality of Life

    Time frame: Baseline, 6 weeks, and 2-month follow-up

    Measured by the EORTC QLQ-BR23

    Change in breast cancer-specific quality of life measured using the EORTC QLQ-BR23. Scores are transformed to a 0-100 scale. Higher scores indicate better functioning and worse symptoms, depending on the subscale.

Study contacts

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

Yasemin Nazlı, Clinical Nurse Specialist

CONTACT

[email protected]

+905325025158

Sponsors and collaborators

Lead sponsor

Yasemin Nazli

Other

Registry information

Official study title

The Effect of a Web-Based Supportive Psychoeducation Program on Psychological Well-Being, Quality of Life and Fear of Recurrence Applied to Patients Who Completed Active Breast Cancer Treatment

Acronym: Psychoeducatio

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

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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