Clinical trial NCT06676228: Fear of Cancer Recurrence Therapy (FORT): Turkish Cultural Adaptation and Implementation Project
Official title: Fear of Cancer Recurrence Therapy (FORT): Turkish Cultural Adaptation and Implementation Project
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
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
Lead sponsor: Maltepe University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
name: Psiko-Onkologlar Dernegi (Turkish Psycho-Oncological Association)
name: Oz Psikolojik Danismanlik Merkezi (Oz Psychological Consultancy)
First posted: 2024-11-06
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Decreased Fear of cancer recurrences scores
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Higher level of Cancer Coping
timeFrame: 3 months and 6 months
measure: Higher level of tolerance of uncertainty
timeFrame: 3 months and 6 months
measure: Higher level of Self Efficacy
timeFrame: 3 months and 6 months
measure: Higher level of Quality of Life
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Maltepe University
Study officials:
affiliation: Istanbul Maltepe University
name: Asli Eyrenci, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkish Psycho-Oncological Association (Psiko-Onkologlar Dernegi)
name: Ozan Bahcivan, PhD
role: STUDY_DIRECTOR
References: