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NCT06676228

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

Completed NA Last updated 2 October 2025
What this trial tests

NA trial testing Fear of cancer recurrence therapy (FORT) in Self Efficacy in 100 participants. Completed in 26 September 2025.

Timeline
1 October 2024
Primary endpoint
26 September 2025
26 September 2025

Quick facts

Lead sponsorMaltepe University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment100
Start date1 October 2024
Primary completion26 September 2025
Estimated completion26 September 2025
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Maltepe University

Who can join

Adults 18 to 65, female only, with Self Efficacy or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Preliminary Outcomes of a Culturally Adapted Fear of Recurrence Therapy (FORT) for Turkish Breast Cancer Survivors: A Randomized Controlled Trial.
    Eyrenci A, Ertuna L, Bahçivan O. · · 2025 · PMID 41318944 · DOI 10.1002/pon.70345

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Other recruiting trials for Self Efficacy

Currently open trials in the same condition.

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