Breast CancerPsychoeducatioNCT07284030
Psychoeducation and Well-Being After Breast Cancer
A study testing Web-Based Psychoeducation Program in people with Breast Cancer and Breast Cancer Survivors, run by Yasemin Nazli at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Survivors, Breast - Female
- What is being tested?
- Web-Based Psychoeducation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Breast Cancer Outpatient Clinic
Istanbul, 34740
Yasemin Nazlı, MSc, +9005325025158, yasemin.nazli@st.uskudar.edu.tr
About this study
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
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.
Read the 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.
- Being tested
- Web-Based Psychoeducation Program
- Keywords
- Breast cancer, Psychoeducation, Web-based intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Psychoeducation ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants receive a 6-week web-based psychoeducation program plus standard care Receives: Behavioral: Web-Based Psychoeducation Program |
| Control Group | No intervention | Participants receive standard care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 6 weeks (post-intervention), and 2-month follow-up
Secondary outcomes (3)
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.
Measured: Baseline, 6 weeks, and 2-month follow-up
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.
Measured: Baseline, 6 weeks, and 2-month follow-up
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.
Measured: Baseline, 6 weeks, and 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 May 2025
- Primary completion15 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yasemin Nazli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasemin Nazli, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284030
- Sponsor's protocol ID
- UskudarU 22.07.2024
- Acronym
- Psychoeducatio
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 35066338Mateu 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.
PubMed 41032141
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07284030
- Acronym / sponsor ID
- Psychoeducatio / UskudarU 22.07.2024
- Keywords
- Breast cancer, Psychoeducation, Web-based intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Yasemin NazliUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Web-Based Psychoeducation ProgramParticipants receive a 6-week web-based psychoeducation program plus standard care |
| Control Group | No intervention | –Participants receive standard care only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-Based Psychoeducation ProgramSix-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. | Behavioural | Intervention Group |
Primary outcome
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 35066338Karsten 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.
- Background: PubMed 41032141Mateu 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Psychoeducation Program in people with Breast Cancer and Breast Cancer Survivors, run by Yasemin Nazli at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasemin Nazlı, Clinical Nurse Specialist (+905325025158, yasemin.nazli@st.uskudar.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psychological Well-Being (time frame: Baseline, 6 weeks (post-intervention), and 2-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07284030, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.