Psychoeducation and Well-Being After Breast Cancer (Psychoeducatio)

December 14, 2025 updated by: Yasemin Nazli

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants receive a 6-week web-based psychoeducation program plus standard care
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.
No Intervention: Control Group
Participants receive standard care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks, and 2-month follow-up
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.
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yasemin Nazli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 14, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 14, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UskudarU 22.07.2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD sharing decision is pending completion of the doctoral thesis and institutional review of data sharing policies. The decision will consider participant privacy, ethical requirements, and journal publication guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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