Self EfficacyNCT06676228
Fear of Cancer Recurrence Therapy (FORT): Turkish Cultural Adaptation and Implementation Project
A study testing Fear of cancer recurrence therapy (FORT) and cognitive-behavioural therapy (CBT) group in people with Self Efficacy and Anxiety, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
This project had two phases. In the first phase, the group-based Fear of Recurrence Therapy (FORT) was culturally adapted for Turkish cancer survivors (Nüks Korkusu Terapisi, NKT) through a four-stage process based on the WHO and ecological validity frameworks: literature review, translation and expert review of the… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Self Efficacy, Anxiety, Depression Not Otherwise Specified
- What is being tested?
- Fear of cancer recurrence therapy (FORT) and cognitive-behavioural therapy (CBT) group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2024to 26 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women aged 18 to 65 years
- Stage I-III breast cancer in remission
- Primary treatment (surgery, chemotherapy, radiotherapy) completed within the previous 5 years; ongoing adjuvant endocrine therapy permitted
- Score of 8 or above on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)
- Able to take part in online sessions
Who cannot join
- Recurrent or metastatic disease
- Severe psychiatric condition
- Cognitive impairment
- Concurrent psychosocial intervention
- Lack of internet access
- Insufficient Turkish language skills
- Comorbid physical illness causing disability
- Note on changes: The originally registered inclusion criteria specified breast or ovarian cancer, HADS anxiety ≥10 and HADS depression ≥7, and Emotion Thermometer thresholds (depression ≥4; anxiety and distress ≥5). Shortly before registration, in October 2024, these criteria were revised to those listed above because only 30 of the 204 survivors screened met the original criteria, well below the target sample of 136; the registry entry was not updated at that time. The revision was made before baseline outcome assessment and randomisation. The HADS anxiety threshold of 8 was chosen because of its established sensitivity and specificity in oncology populations. No survivors of ovarian cancer were enrolled in the randomised trial because too few eligible survivors of ovarian cancer were identified.
Trial locations and contacts
1 site in 1 country.
About this study
This project had two phases. In the first phase, the group-based Fear of Recurrence Therapy (FORT) was culturally adapted for Turkish cancer survivors (Nüks Korkusu Terapisi, NKT) through a four-stage process based on the WHO and ecological validity frameworks: literature review, translation and expert review of the manual, cognitive interviews with survivors and psycho-oncology experts, and an adaptation workshop.
In the second phase, a two-arm randomised controlled trial compared NKT with an active CBT-based supportive group in women with stage I-III breast cancer. Both interventions were delivered online in six weekly group sessions. The planned sample was 136 participants (68 per arm); 100 were randomised (50 per arm). Questionnaires were completed at baseline (T0), post-treatment (T1), and 3 (T2) and 6 (T3) months after the final session. The primary outcome was the total score of the Turkish Fear of Cancer Recurrence Inventory at 3 and 6 months; secondary outcomes were intolerance of uncertainty, self-efficacy, quality of life and cancer coping. Analyses were planned as repeated-measures ANCOVA within a general linear modelling framework.
Read the detailed description
First Phase: Cultural Adaptation Study
The aim of this study is to adapt the group work module for Fear of Cancer Recurrence (FCR) in breast cancer survivors to the culture of Turkey. In this direction, the following cultural adaptation steps will be followed, Theoretical background of the FCR:
- Document Evaluation: In the first stage, a comprehensive literature review will be conducted to identify the interventions currently implemented in the field of mental health in Turkey for breast cancer survivors.
- Translation and Review: At this stage, the first translation and back-translation of the FCR patient handbook from English to Turkish will be carried out. It will also be evaluated in terms of ecological group modelling.
- Cognitive Interviewing: In this phase, focus interviews will be conducted with experts and breast cancer survivors to assess the comprehensibility, cultural and survivorship context of the NCT patient handbook.
- Adaptation Workshop: In the final stage, a workshop will be held to evaluate the data obtained in the previous stages, make adaptations and suggested changes, and finalise the adapted protocol.
Second phase: Intervention Study The trial was conducted in women with breast cancer only; survivors of ovarian cancer were not enrolled in the randomised trial. Sessions were delivered online via Zoom. A randomised control group study will be conducted within Work Package 2. In the intervention group of the study, the adaptation of the FCR will be applied, and in the control group, Cognitive Behavioural Therapy (CBT) focused group application will be performed. Group facilitators and the investigators collecting outcome data were aware of allocation. Participants were informed of the general aims of their programme but not of the study hypotheses, the content of the other condition or which condition was considered experimental. All outcomes were self-reported.
Participants Participants are planned to consist of clients of Oz Psychological Consultancy Centre and people reached through cancer associations/patient groups. It is planned to give gift vouchers to the participants who will participate in the study. The decision to give gift vouchers was made in order to minimise potential drop-out rate in this project.
- Conditions
- Self Efficacy, Anxiety, Depression Not Otherwise Specified, Fear of Cancer Recurrence, Cancer Coping, Quality of Life (QOL)
- Being tested
- Fear of cancer recurrence therapy (FORT), cognitive-behavioural therapy (CBT) group
- Keywords
- FORT, Fear of cancer recurrence, Turkish, Fear of cancer recurrence therapy, breast cancer, cancer survivor
- Medical subject headings
- Anxiety Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fear of cancer recurrence therapy (FORT)Behavioural
FORT consists of 6 sessions in total, the scopes of the sessions are detailed below:
Session 1 (Acquiring new skills to cope with Fear of Cancer Recurrence (FCR)) HOMEWORK: Daily practice of progressive muscle relaxation exercise; creation of a thought record
Session 2 (Providing information on symptoms of cancer recurrence and increasing tolerance to uncertainty) HOMEWORK: Listening to recordings of relaxation exercises every day; practising self-calming, keeping a record of thoughts
Session 3 (Developing coping skills) HOMEWORK: Practise guided imagery daily; debunk erroneous beliefs about the benefits of worrying; keep a thought log
Session 4 (Deepening the underlying fears) HOMEWORK: Reading the worst case fear scenario every day, practising daily self-care and mindfulness practices
Session 5 (Moving beyond specific fears) HOMEWORK: Writing goals and priorities for the future
Session 6 (Review and conclusion) Reviewing all the discussed content
cognitive-behavioural therapy (CBT) groupBehavioural
The cognitive-behavioural therapy (CBT) oriented control group consisted of a total of 6 sessions. The scopes of the sessions are given in detail below.
Session 1: Introduction and cancer-focused psychoeducation with CBT HOMEWORK: Keeping a thought diary
Session 2: Addressing the underlying causes of thoughts HOMEWORK: Keeping a thought diary about underlying beliefs
Session 3: Recognising conflicts HOMEWORK: Task: Keep a diary of thoughts about disagreements (what gives us pleasure and what we should master)
Session 4: Effective communication techniques HOMEWORK: Keeping a diary about the use of the word "good enough"
Session 5: Discussion of the definitions of anxiety and depression
Session 6: Anger Management HOMEWORK: HOMEWORK: Keeping a diary about the use of the breathing exercise
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | FORT consists of 6 sessions in total, the scopes of the sessions are detailed below:
Session 1 (Acquiring new skills to cope with Fear of Cancer Recurrence (FCR)) HOMEWORK: Daily practice of progressive muscle relaxation exercise; creation of a thought record
Session 2 (Providing information on symptoms of cancer recurrence and increasing tolerance to uncertainty) HOMEWORK: Listening to recordings of relaxation exercises every day; practising self-calming, keeping a record of thoughts
Session 3 (Developing coping skills) HOMEWORK: Practise guided imagery daily; debunk erroneous beliefs about the benefits of worrying; keep a thought log
Session 4 (Deepening the underlying fears) HOMEWORK: Reading the worst case fear scenario every day, practising daily self-care and mindfulness practices
Session 5 (Moving beyond specific fears) HOMEWORK: Writing goals and priorities for the future
Session 6 (Review and conclusion) Reviewing all the discussed content Receives: Behavioral: Fear of cancer recurrence therapy (FORT) |
| Control Group (active comparator) | Active comparator | The cognitive-behavioural therapy (CBT) oriented control group consisted of a total of 6 sessions. The scopes of the sessions are given in detail below.
Session 1: Introduction and cancer-focused psychoeducation with CBT HOMEWORK: Keeping a thought diary
Session 2: Addressing the underlying causes of thoughts HOMEWORK: Keeping a thought diary about underlying beliefs
Session 3: Recognising conflicts HOMEWORK: Task: Keep a diary of thoughts about disagreements (what gives us pleasure and what we should master)
Session 4: Effective communication techniques HOMEWORK: Keeping a diary about the use of the word "good enough"
Session 5: Discussion of the definitions of anxiety and depression
Session 6: Anger Management HOMEWORK: HOMEWORK: Keeping a diary about the use of the breathing exercise Receives: Behavioral: cognitive-behavioural therapy (CBT) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased Fear of cancer recurrences scores
Patients score will change for the Fear of Cancer Recurrence Inventory. Total score of the validated Turkish version of the Fear of Cancer Recurrence Inventory (FCRI; Eyrenci \& Sertel Berk, 2018). The Turkish version has 24 items rated on a 0-4 scale across five factors (triggers, functional impairments, recurrence-related metacognitions, emotion-focused coping and quality of life). Total scores range from 0 to 96; higher scores indicate greater fear of cancer recurrence.
Measured: 3 months and 6 months
Secondary outcomes (4)
Higher level of Cancer Coping
Participants score will change at the cancer coping questionnaire (CCQ). There are 21 items within this scale. The scale assesses the personal dimension with scores ranging from 1 to 4. Higher scores on the scale indicate that the specified coping method is used more frequently.
Measured: 3 months and 6 months
Higher level of tolerance of uncertainty
Participants score will change in Intolerance of Uncertainty Scale. This scale consists of 12 items measured by responses on a 5-point Likert scale, and it includes two sub-dimensions: "future anxiety" and "preventive anxiety." The total score that can be obtained from the scale ranges from 12 to 60. A high score on the scale indicates a high level of intolerance to uncertainty.
Measured: 3 months and 6 months
Higher level of Self Efficacy
Participant score will change in Self-Efficacy for Managing Chronic Disease (SEMCD) scale. The scale consists of 6 items and is evaluated on a 10-point Likert scale, where "1" represents "not at all sure" and "10" represents "completely sure." As the score obtained from the scale increases, the individual's self-efficacy related to their chronic illness also increases.
Measured: 3 months and 6 months
Higher level of Quality of Life
Participants score will change in EORTC QLQ-C30 - Quality of Life questionnaire. The scale consists of subscales that evaluate overall health status, functionality (including physical, role, emotional, cognitive, and social functioning), and the presence of symptoms, totaling 30 items. Low scores on the functional subscales indicate low quality of life, while low scores on the symptom subscale, which assesses symptoms such as fatigue, pain, nausea, and vomiting, indicate high quality of life. The first 28 items of the scale are evaluated using 4-point Likert response options, while the 29th and 30th items, related to overall health status, are assessed using 7-point Likert response options. The scores obtained from the scale range from 0 to 100 for each subscale.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start22 Oct 2024
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
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 Self EfficacyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Psiko-Onkologlar Dernegi (Turkish Psycho-Oncological Association), Oz Psikolojik Danismanlik Merkezi (Oz Psychological Consultancy)
- Responsible party
- Principal investigator, ASLI EYRENCI, Maltepe University
- Investigators
- Asli Eyrenci, PhD, Principal investigator, Istanbul Maltepe UniversityOzan Bahcivan, PhD, Study director, Turkish Psycho-Oncological Association (Psiko-Onkologlar Dernegi)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676228
- Sponsor's protocol ID
- 2023/15-11
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data may be made available on reasonable request to the principal investigator, subject to approval by the Maltepe University ethics committee and a data-sharing agreement. Data will not be made publicly available because participants did not consent to public data sharing.
Publications
Eyrenci A, Ertuna L, Bahcivan O. Cultural adaptation of the fear of cancer recurrence therapy (FORT) for Turkish breast cancer survivors. BMC Psychol. 2026 Jun 15;14(1):1078. doi: 10.1186/s40359-026-04915-6.
PubMed 42289732Eyrenci A, Ertuna L, Bahcivan O. Preliminary Outcomes of a Culturally Adapted Fear of Recurrence Therapy (FORT) for Turkish Breast Cancer Survivors: A Randomized Controlled Trial. Psychooncology. 2025 Dec;34(12):e70345. doi: 10.1002/pon.70345.
PubMed 41318944
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fear of Cancer Recurrence Therapy (FORT): Turkish Cultural Adaptation and Implementation Project
- ClinicalTrials.gov ID
- NCT06676228
- Acronym / sponsor ID
- 2023/15-11
- Conditions
- Self Efficacy, Anxiety, Depression Not Otherwise Specified, Fear of Cancer Recurrence, Cancer Coping, Quality of Life (QOL)
- Keywords
- FORT, Fear of cancer recurrence, Turkish, Fear of cancer recurrence therapy, breast cancer, cancer survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Psiko-Onkologlar Dernegi (Turkish Psycho-Oncological Association), Oz Psikolojik Danismanlik Merkezi (Oz Psychological Consultancy)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 6 Nov 2024 (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 project had two phases. In the first phase, the group-based Fear of Recurrence Therapy (FORT) was culturally adapted for Turkish cancer survivors (Nüks Korkusu Terapisi, NKT) through a four-stage process based on the WHO and ecological validity frameworks: literature review, translation and expert review of the manual, cognitive interviews with survivors and psycho-oncology experts, and an adaptation workshop.
In the second phase, a two-arm randomised controlled trial compared NKT with an active CBT-based supportive group in women with stage I-III breast cancer. Both interventions were delivered online in six weekly group sessions. The planned sample was 136 participants (68 per arm); 100 were randomised (50 per arm). Questionnaires were completed at baseline (T0), post-treatment (T1), and 3 (T2) and 6 (T3) months after the final session. The primary outcome was the total score of the Turkish Fear of Cancer Recurrence Inventory at 3 and 6 months; secondary outcomes were intolerance of uncertainty, self-efficacy, quality of life and cancer coping. Analyses were planned as repeated-measures ANCOVA within a general linear modelling framework.
Detailed description
First Phase: Cultural Adaptation Study
The aim of this study is to adapt the group work module for Fear of Cancer Recurrence (FCR) in breast cancer survivors to the culture of Turkey. In this direction, the following cultural adaptation steps will be followed, Theoretical background of the FCR:
- Document Evaluation: In the first stage, a comprehensive literature review will be conducted to identify the interventions currently implemented in the field of mental health in Turkey for breast cancer survivors.
- Translation and Review: At this stage, the first translation and back-translation of the FCR patient handbook from English to Turkish will be carried out. It will also be evaluated in terms of ecological group modelling.
- Cognitive Interviewing: In this phase, focus interviews will be conducted with experts and breast cancer survivors to assess the comprehensibility, cultural and survivorship context of the NCT patient handbook.
- Adaptation Workshop: In the final stage, a workshop will be held to evaluate the data obtained in the previous stages, make adaptations and suggested changes, and finalise the adapted protocol.
Second phase: Intervention Study The trial was conducted in women with breast cancer only; survivors of ovarian cancer were not enrolled in the randomised trial. Sessions were delivered online via Zoom. A randomised control group study will be conducted within Work Package 2. In the intervention group of the study, the adaptation of the FCR will be applied, and in the control group, Cognitive Behavioural Therapy (CBT) focused group application will be performed. Group facilitators and the investigators collecting outcome data were aware of allocation. Participants were informed of the general aims of their programme but not of the study hypotheses, the content of the other condition or which condition was considered experimental. All outcomes were self-reported.
Participants Participants are planned to consist of clients of Oz Psychological Consultancy Centre and people reached through cancer associations/patient groups. It is planned to give gift vouchers to the participants who will participate in the study. The decision to give gift vouchers was made in order to minimise potential drop-out rate in this project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Fear of cancer recurrence therapy (FORT)FORT consists of 6 sessions in total, the scopes of the sessions are detailed below: Session 1 (Acquiring new skills to cope with Fear of Cancer Recurrence (FCR)) HOMEWORK: Daily practice of progressive muscle relaxation exercise; creation of a thought record Session 2 (Providing information on symptoms of cancer recurrence and increasing tolerance to uncertainty) HOMEWORK: Listening to recordings of relaxation exercises every day; practising self-calming, keeping a record of thoughts Session 3 (Developing coping skills) HOMEWORK: Practise guided imagery daily; debunk erroneous beliefs about the benefits of worrying; keep a thought log Session 4 (Deepening the underlying fears) HOMEWORK: Reading the worst case fear scenario every day, practising daily self-care and mindfulness practices Session 5 (Moving beyond specific fears) HOMEWORK: Writing goals and priorities for the future Session 6 (Review and conclusion) Reviewing all the discussed content |
| Control Group (active comparator) | Active comparator | Behavioral: cognitive-behavioural therapy (CBT) groupThe cognitive-behavioural therapy (CBT) oriented control group consisted of a total of 6 sessions. The scopes of the sessions are given in detail below. Session 1: Introduction and cancer-focused psychoeducation with CBT HOMEWORK: Keeping a thought diary Session 2: Addressing the underlying causes of thoughts HOMEWORK: Keeping a thought diary about underlying beliefs Session 3: Recognising conflicts HOMEWORK: Task: Keep a diary of thoughts about disagreements (what gives us pleasure and what we should master) Session 4: Effective communication techniques HOMEWORK: Keeping a diary about the use of the word "good enough" Session 5: Discussion of the definitions of anxiety and depression Session 6: Anger Management HOMEWORK: HOMEWORK: Keeping a diary about the use of the breathing exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 18 to 65 years
- Stage I-III breast cancer in remission
- Primary treatment (surgery, chemotherapy, radiotherapy) completed within the previous 5 years; ongoing adjuvant endocrine therapy permitted
- Score of 8 or above on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)
- Able to take part in online sessions
Key exclusion criteria (8 listed)
- Recurrent or metastatic disease
- Severe psychiatric condition
- Cognitive impairment
- Concurrent psychosocial intervention
- Lack of internet access
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 |
|---|---|---|
| Fear of cancer recurrence therapy (FORT)FORT consists of 6 sessions in total, the scopes of the sessions are detailed below: Session 1 (Acquiring new skills to cope with Fear of Cancer Recurrence (FCR)) HOMEWORK: Daily practice of progressive muscle relaxation exercise; creation of a thought record Session 2 (Providing information on symptoms of cancer recurrence and increasing tolerance to uncertainty) HOMEWORK: Listening to recordings of relaxation exercises every day; practising self-calming, keeping a record of thoughts Session 3 (Developing coping skills) HOMEWORK: Practise guided imagery daily; debunk erroneous beliefs about the benefits of worrying; keep a thought log Session 4 (Deepening the underlying fears) HOMEWORK: Reading the worst case fear scenario every day, practising daily self-care and mindfulness practices Session 5 (Moving beyond specific fears) HOMEWORK: Writing goals and priorities for the future Session 6 (Review and conclusion) Reviewing all the discussed content | Behavioural | Experimental Group |
| cognitive-behavioural therapy (CBT) groupThe cognitive-behavioural therapy (CBT) oriented control group consisted of a total of 6 sessions. The scopes of the sessions are given in detail below. Session 1: Introduction and cancer-focused psychoeducation with CBT HOMEWORK: Keeping a thought diary Session 2: Addressing the underlying causes of thoughts HOMEWORK: Keeping a thought diary about underlying beliefs Session 3: Recognising conflicts HOMEWORK: Task: Keep a diary of thoughts about disagreements (what gives us pleasure and what we should master) Session 4: Effective communication techniques HOMEWORK: Keeping a diary about the use of the word "good enough" Session 5: Discussion of the definitions of anxiety and depression Session 6: Anger Management HOMEWORK: HOMEWORK: Keeping a diary about the use of the breathing exercise | Behavioural | Control Group (active comparator) |
Primary outcome
Decreased Fear of cancer recurrences scores
Time frame: 3 months and 6 months
Patients score will change for the Fear of Cancer Recurrence Inventory. Total score of the validated Turkish version of the Fear of Cancer Recurrence Inventory (FCRI; Eyrenci \& Sertel Berk, 2018). The Turkish version has 24 items rated on a 0-4 scale across five factors (triggers, functional impairments, recurrence-related metacognitions, emotion-focused coping and quality of life). Total scores range from 0 to 96; higher scores indicate greater fear of cancer recurrence.
4 secondary outcomes
Higher level of Cancer Coping
Time frame: 3 months and 6 months
Higher level of tolerance of uncertainty
Time frame: 3 months and 6 months
Higher level of Self Efficacy
Time frame: 3 months and 6 months
Higher level of Quality of Life
Time frame: 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Results publication: PubMed 42289732Eyrenci A, Ertuna L, Bahcivan O. Cultural adaptation of the fear of cancer recurrence therapy (FORT) for Turkish breast cancer survivors. BMC Psychol. 2026 Jun 15;14(1):1078. doi: 10.1186/s40359-026-04915-6.
- Derived from this study: PubMed 41318944Eyrenci A, Ertuna L, Bahcivan O. Preliminary Outcomes of a Culturally Adapted Fear of Recurrence Therapy (FORT) for Turkish Breast Cancer Survivors: A Randomized Controlled Trial. Psychooncology. 2025 Dec;34(12):e70345. doi: 10.1002/pon.70345.
- Individual participant dataSharing planned: Yes. De-identified participant data may be made available on reasonable request to the principal investigator, subject to approval by the Maltepe University ethics committee and a data-sharing agreement. Data will not be made publicly available because participants did not consent to public data sharing.
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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. This study is not recruiting at the moment.
Asli Eyrenci, PhD principal investigator
Istanbul Maltepe University
Ozan Bahcivan, PhD study director
Turkish Psycho-Oncological Association (Psiko-Onkologlar Dernegi)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fear of cancer recurrence therapy (FORT) and cognitive-behavioural therapy (CBT) group in people with Self Efficacy and Anxiety, run by Maltepe University 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 5 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: finished, as of the sponsor's last update on 30 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased Fear of cancer recurrences scores (time frame: 3 months and 6 months). 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 NCT06676228, 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 30 Oct 2026.