Psychoeducation and Well-Being After Breast Cancer

NCT07284030 | Recruiting

• 1 other identifier: UskudarU 22.07.2024
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast - Female; Psycho-Oncology; Breast Cancer; Breast Cancer Survivors

Keywords

Breast cancer; Psychoeducation; Web-based intervention

Outcome Measures

Primary Outcomes (2)

• Change in Psychological Well-Being

  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.

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

• Change in Fear of Cancer Recurrence

  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.

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

Secondary Outcomes (3)

• Change in Cancer-Related Quality of Life

  Baseline, 6 weeks, and 2-month follow-up

• Change in Hopelessness

  Baseline, 6 weeks, and 2-month follow-up

• Change in Breast Cancer-Specific Quality of Life

  Baseline, 6 weeks, and 2-month follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants receive a 6-week web-based psychoeducation program plus standard care

Behavioral: Web-Based Psychoeducation Program

Control Group

NO INTERVENTION

Participants receive standard care only

Interventions

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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yasemin Nazli: lead

Study Sites (1)

Breast Cancer Outpatient Clinic

Istanbul, 34740, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yasemin Nazlı, Clinical Nurse Specialist

CONTACT

+905325025158; yasemin.nazli@st.uskudar.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study where masking is not feasible due to the nature of the intervention. Participants in the intervention group actively engage in weekly online psychoeducation sessions via Zoom and access the study website (www.onkodestek.org), while the control group receives standard care only. Both participants and researchers are aware of group allocation. The interactive nature of the psychoeducation program and direct participant-researcher contact during sessions make blinding impossible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Advanced Practice Nurse

Model Details: Two-arm parallel group randomized controlled trial comparing web-based psychoeducation program plus standard care versus standard care alone in breast cancer survivors.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 16, 2025
• Study Start: May 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: February 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

TU (1)