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

Maltepe University

Status: Completed

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

Treatments: Behavioral: cognitive-behavioural therapy (CBT) group; Behavioral: Fear of cancer recurrence therapy (FORT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06676228

2023/15-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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

Treatment:

Behavioral: Fear of cancer recurrence therapy (FORT)

Control Group (active comparator)

Active Comparator group

Description:

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

Treatment:

Behavioral: cognitive-behavioural therapy (CBT) group