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

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

Interventions

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

Sponsors & Collaborators

• The Scientific and Technological Research Council of Turkey

  collaborator OTHER

• Psiko-Onkologlar Dernegi (Turkish Psycho-Oncological Association)

  collaborator UNKNOWN

• Oz Psikolojik Danismanlik Merkezi (Oz Psychological Consultancy)

  collaborator UNKNOWN

• Maltepe University

  lead OTHER

Principal Investigators

• Asli Eyrenci, PhD · Istanbul Maltepe University

• Ozan Bahcivan, PhD · Turkish Psycho-Oncological Association (Psiko-Onkologlar Dernegi)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2025-09-26

Completion

2025-09-26

Countries

• Turkey (Türkiye)

Study Locations