Trials / Completed

CompletedNCT06676228

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

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 100 (actual)

Sponsor: Maltepe University · Academic / Other
Sex: Female
Age: 18 Years – 65 Years
Healthy volunteers: Not accepted

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.

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 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

Interventions

Type	Name	Description
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
BEHAVIORAL	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

Timeline

Start date: 2024-10-01
Primary completion: 2025-09-26
Completion: 2025-09-26
First posted: 2024-11-06
Last updated: 2025-10-02

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06676228. Inclusion in this directory is not an endorsement.