Fear of Cancer Recurrence Therapy (FORT): Turkish Cultural Adaptation and Implementation Project

NCT06676228 | Completed DMC

• 1 other identifier: 2023/15-11
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This research consists of two phases. The aim of the first study is to adapt the group work module of Fear of Cancer Recurrence (FCR) for FCR in survivors of breast and ovarian cancer patients to the Turkish culture. For cultural adaptation, a process consisting of four stages is planned to be followed based on the World Health Organisation (WHO) and ecological validity model: 1) literature review; 2) translation of the intervention manual from English to Turkish and evaluation of the translation by experts; 3) cognitive interviews with ovarian and breast cancer patients and experts working in the field of psychooncology about the sections of the translated manual; and 4) an adaptation workshop where data from the previous stages were collected and analysed. The aim of the second study, 6-week, 120-minute FCR (n= 68) or CBT intervention (n= 68) group sessions with participants from ovarian and breast cancer patients. They will be completing questionnaires at baseline (T0), post-treatment right after treatment ends (T1), 3 months (T2), and 6 months (T3) post-treatment. A generalized linear model will be used for the analysis of collected data, incorporating customized analyses such as ANCOVA for repeated measures and analysis of variance for repeated measures. The primary outcome will be compared to the Fear of Cancer Recurrence Inventory (FCRI) total score and group differences in secondary outcomes. 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.

Conditions

Self Efficacy; Anxiety; Depression Not Otherwise Specified; Fear of Cancer Recurrence; Cancer Coping; Quality of Life (QOL); Intolerance of Uncertainty

Keywords

FORT; Fear of cancer recurrence; Turkish; Fear of cancer recurrence therapy; breast cancer; cancer survivor

Outcome Measures

Primary Outcomes (1)

• Decreased Fear of cancer recurrences scores

  Patients score will change for the Fear of Cancer Recurrence Inventory. There are seven sub-dimensions: triggers, violence, psychological distress, coping strategies, functional impairments, insight, and search for reassurance. The triggers sub-dimension contains eight items, the violence sub-dimension contains nine items, the psychological distress sub-dimension contains four items, the coping strategies sub-dimension contains nine items, the functional impairments sub-dimension contains six items, the insight sub-dimension contains three items, and the search for reassurance sub-dimension contains three items, totaling 42 items. Additionally, there are five sub-dimensions: triggers, functional impairments, higher-order cognitions related to relapse, emotion-focused coping strategies, and quality of life, consisting of 24 items evaluated using a four-point Likert scale. As the scores obtained from the scale increase, so does the Fear of Cancer Recurrence.

  3 months and 6 months

Secondary Outcomes (4)

• Higher level of Cancer Coping

  3 months and 6 months

• Higher level of tolerance of uncertainty

  3 months and 6 months

• Higher level of Self Efficacy

  3 months and 6 months

• Higher level of Quality of Life

  3 months and 6 months

Study Arms (2)

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

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

Behavioral: cognitive-behavioural therapy (CBT) group

Interventions

Fear of cancer recurrence therapy (FORT) BEHAVIORAL

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

Experimental Group

cognitive-behavioural therapy (CBT) group BEHAVIORAL

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

Control Group (active comparator)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: People who were born with female genitals (vagina).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are under 18 years of age
• 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.

You may not qualify if:

• Participants over 65 years of age
• 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.

Sponsors & Collaborators

• Maltepe University: lead
• The Scientific and Technological Research Council of Turkey: collaborator
• Psiko-Onkologlar Dernegi (Turkish Psycho-Oncological Association): collaborator
• Oz Psikolojik Danismanlik Merkezi (Oz Psychological Consultancy): collaborator

Study Sites (1)

Istanbul Maltepe University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Eyrenci 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.

  PMID: 41318944 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Breast Neoplasms

Interventions

Cognitive Behavioral Therapy; Population Groups

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Demography; Population Characteristics

Study Officials

• Asli Eyrenci, PhD

  Istanbul Maltepe University

  PRINCIPAL INVESTIGATOR

• Ozan Bahcivan, PhD

  Turkish Psycho-Oncological Association (Psiko-Onkologlar Dernegi)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Group leaders/care providers and investigators know the group assignments but the participants do not know which group they were assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 6, 2024
• Study Start: October 1, 2024
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)