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Recruiting NCT07284030

Psychoeducation and Well-Being After Breast Cancer

No phase Interventional Breast Cancer Breast Cancer Survivors Breast - Female Psycho-Oncology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Web-Based Psychoeducation Program.
Who it may be relevant to
Registry conditions: Breast Cancer, Breast Cancer Survivors, Breast - Female, Psycho-Oncology. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Web-Based Psychoeducation Program
    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 outcome measures

  • Change in Psychological Well-Being [Time frame: Baseline, 6 weeks (post-intervention), and 2-month follow-up]
  • Change in Fear of Cancer Recurrence [Time frame: Baseline, 6 weeks (post-intervention), and 2-month follow-up]
Secondary outcome measures (3)
  • Change in Cancer-Related Quality of Life [Time frame: Baseline, 6 weeks, and 2-month follow-up]
  • Change in Hopelessness [Time frame: Baseline, 6 weeks, and 2-month follow-up]
  • Change in Breast Cancer-Specific Quality of Life [Time frame: Baseline, 6 weeks, and 2-month follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Breast Cancer Outpatient Clinic — Istanbul

Publications

  • Karsten MM, Roehle R, Albers S, Pross T, Hage AM, Weiler K, Fischer F, Rose M, Kuhn F, Blohmer JU. Real-world reference scores for EORTC QLQ-C30 and EORTC QLQ-BR23 in early breast cancer patients. Eur J Cancer. 2022 Mar;163:128-139. doi: 10.1016/j.ejca.2021.12.020. Epub 2022 Jan 20. PMID 35066338
  • Mateu P, Teixidor-Batlle C, Suarez-Alcazar MP, Salas-Medina P, Catala-Vilaplana I, Hernando-Domingo C, Muriach M, Collado-Boira E. A qualitative case study of body image in women with breast cancer participating in an exercise program. Support Care Cancer. 2025 Oct 1;33(10):893. doi: 10.1007/s00520-025-09963-z. PMID 41032141

Identifiers

NCT: NCT07284030 · UskudarU 22.07.2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗