Prevention of post-traumatic stress symptoms in women with breast cancer Mental and Behavioural Disorders
Conditions
Interventions
The study sample will consist of patients referred to the Breast Unit of the Complex Oncology Department at ASST Rhodense. The sample size was defined based on:
1. a priori power analysis, and
2. the
Sponsors
Aziende Socio Sanitaria Territoriale Rhodense
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Female participants aged between 18 and 80 years 2. First diagnosis of breast cancer (any stage without metastasis) 3. Scheduled for surgical intervention (mastectomy or quadrantectomy) 4. Good comprehension of the Italian language, sufficient to understand consent procedures and complete psychological questionnaires 5. Ability and willingness to provide written informed consent 6. Voluntary participation and availability to attend all assessment and intervention sessions
Exclusion criteria
Exclusion criteria: 1. Presence of metastatic disease 2. Presence of cognitive impairment that compromises understanding of the informed consent process and/or the completion of assessment instruments 3. Current or past severe psychiatric disorder (e.g., psychosis, bipolar disorder) requiring pharmacological treatment 4. Concurrent participation in other psychological intervention trials that could interfere with study outcomes 5. Inability to attend scheduled sessions or complete follow-up assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psychological distress measured using the Psychological Distress Inventory – Revised (PDI-R) at three time points: baseline (T0, pre-surgery), post-surgery (T1, within one week after surgery, before randomization), and post-intervention follow-up (T2, after eight weeks of treatment and within three months after surgery). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include additional psychological domains assessed to evaluate the broader impact of each intervention. Each variable will be measured at three time points: baseline (T0, pre-surgery), post-surgery (T1, within one week after surgery), and post-intervention follow-up (T2, after eight weeks of treatment and within three months after surgery): Anxiety and depression, measured using the Hospital Anxiety and Depression Scale (HADS) Post-traumatic stress symptoms, measured using the Post-Traumatic Symptom Questionnaire (PTSQ) Hopelessness, measured using the Brief Assessment of Hopelessness (BAH) Body image, measured using the Body Image Scale (BIS) Overall psychological functioning and well-being, measured using the Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM) | — |
Countries
Italy
Contacts
Public ContactLivia Emma Ligorio
Outcome results
None listed