Breast Cancer, Breast Cancer Survivors, Breast - Female, Psycho-Oncology
Conditions
Keywords
Breast cancer, Psychoeducation, Web-based intervention
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.
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
BEHAVIORALWeb-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.
Sponsors
Yasemin Nazli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Intervention model description
Two-arm parallel group randomized controlled trial comparing web-based psychoeducation program plus standard care versus standard care alone in breast cancer survivors.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Psychological Well-Being | 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. |
| Change in Fear of Cancer Recurrence | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Cancer-Related Quality of Life | 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. |
| Change in Hopelessness | 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. |
| Change in Breast Cancer-Specific Quality of Life | 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactYasemin Nazlı, Clinical Nurse Specialist
Outcome results
None listed