Fear of Cancer Recurrence Therapy (FORT): Turkish Cultural Adaptation and Implementation Project
NCT ID: NCT06676228
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2024-10-01
2025-09-26
Brief Summary
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With this project, it is aimed to bring the group intervention module for FCR, which is a common problem in surviving cancer patients that will greatly contribute to the psycho-oncology practice in Turkiye. In addition, it is thought that this project is important both because there is no study on cancer survivors and FCR in this context and cultural adaptation studies are crucially limited in Turkey.
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Detailed Description
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The aim of this study is to adapt the group work module for Fear of Cancer Recurrence (FCR) in breast and ovarian cancer survivors to the culture of Turkey. In this direction, the following cultural adaptation steps will be followed, Theoretical background of the FCR:
1. 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 and ovarian cancer survivors.
2. 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.
3. Cognitive Interviewing: In this phase, focus interviews will be conducted with experts and breast and ovarian cancer survivors to assess the comprehensibility, cultural and survivorship context of the NCT patient handbook.
4. 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
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. This study is planned as a single-blind study (a study in which the group leaders know the group assignments but the group members do not know which group they are in).
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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental Group
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
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)
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
cognitive-behavioural therapy (CBT) group
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
Interventions
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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
cognitive-behavioural therapy (CBT) group
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
Eligibility Criteria
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Inclusion Criteria
* Participants whose primary treatment (chemotherapy, radiotherapy, surgery) has been completed (adjuvant treatment such as hormone therapy may be continued can be accepted into the study).
* Participants with stage I-III breast cancer and ovarian cancer who have completed treatment less than 5 years ago and whose disease is in remission.
* Participants who receive cut-off scores of 10 or above for the anxiety and 7 or above for the depression Hospital and Anxiety Scale.
* Participants who score 4 for depression and 5 for anxiety and distress for the Emotion Thermometer.
Exclusion Criteria
* Participants who experience of recurrence/metastasis
* Participants who has mental retardation
* Participants who do not possess Turkish language skills
* Participants who have another comorbid physical illness that causes disability
* Participants who were diagnosed with a psychiatric disorder.
18 Years
65 Years
FEMALE
No
Sponsors
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The Scientific and Technological Research Council of Turkey
OTHER
Psiko-Onkologlar Dernegi (Turkish Psycho-Oncological Association)
UNKNOWN
Oz Psikolojik Danismanlik Merkezi (Oz Psychological Consultancy)
UNKNOWN
Maltepe University
OTHER
Responsible Party
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ASLI EYRENCI
Assist. Prof.
Principal Investigators
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Asli Eyrenci, PhD
Role: PRINCIPAL_INVESTIGATOR
Istanbul Maltepe University
Ozan Bahcivan, PhD
Role: STUDY_DIRECTOR
Turkish Psycho-Oncological Association (Psiko-Onkologlar Dernegi)
Locations
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Istanbul Maltepe University
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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2023/15-11
Identifier Type: -
Identifier Source: org_study_id
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