Psychoeducation and Well-Being After Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorYasemin Nazli
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Web-Based Psychoeducation Program
BehavioralSix-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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 6 weeks (post-intervention), and 2-month follow-up2
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.
Time frame
Baseline, 6 weeks (post-intervention), and 2-month follow-upSecondary outcomes
1
Change in Cancer-Related Quality of Life
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.
Time frame
Baseline, 6 weeks, and 2-month follow-up2
Change in Hopelessness
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.
Time frame
Baseline, 6 weeks, and 2-month follow-up3
Change in Breast Cancer-Specific Quality of Life
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.
Time frame
Baseline, 6 weeks, and 2-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yasemin Nazli
Lead sponsor
Uskudar University
Sponsor institution
Source ClinicalTrials.gov