Psychotherapy for advanced cancer patients in Italy
Effectiveness of a Brief Manualized Intervention Managing Cancer and Living Meaningfully (CALM) Adapted to the Italian Cancer Care Setting. Study Protocol for a Randomized Controlled Trial
This study tests a short therapy program called CALM to see if it helps people with advanced cancer in Italy feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 171 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Università degli Studi di Ferrara Academic / other |
| Locations | 1 site (Ferrara, Emilia-Romagna) |
| Trial ID | NCT03068013 on ClinicalTrials.gov |
What this trial studies
This clinical trial tests the effectiveness of a brief psychotherapeutic intervention called Managing Cancer and Living Meaningfully (CALM) for patients with advanced cancer in Italy. The study involves a randomized controlled design with participants receiving either the CALM intervention or a nonspecific supportive intervention. The CALM intervention consists of 12 individual sessions focusing on symptom management, personal relationships, spiritual well-being, and preparing for the future. Assessments will be conducted at baseline, 3 months, and 6 months to evaluate outcomes such as depression, anxiety, and quality of life.
Who should consider this trial
Good fit: Ideal candidates are Italian-speaking adults aged 18 and older with advanced cancer and symptoms of depression or anxiety.
Not a fit: Patients who are actively seeing a psychotherapist or have communication difficulties may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and quality of life for patients with advanced cancer.
How similar studies have performed: Previous studies have shown success with similar psychotherapeutic approaches in cancer care, indicating potential for positive outcomes in this adaptation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years of age or more 2. fluency in Italian language; 3. no cognitive impairment; 4. confirmed or working diagnosis of "wet" stage IIIB (those not treated with curative intent) or IV lung cancer; any stage of pancreatic or stage IV GI cancer, stage III or IV ovarian and fallopian tube cancers, or other stage IV gynecological cancer; and stage IV breast, genitourinary, sarcoma, melanoma or endocrine cancers (expected survival of 12-18 months); a score ≥10 at the Patient Health Questionnaire (PHQ9) or ≥ 20 at the Death and Dying Distress Scale (DDAS). - Exclusion Criteria: 1. communication difficulties; 2. inability to commit to the required 6 sessions (i.e., too ill to participate, lack of transportation, etc.); 3. actively seeing a psychotherapist, and
Where this trial is running
Ferrara, Emilia-Romagna
- Università di Ferrara — Ferrara, Emilia-Romagna, Italy (Recruiting)
Study contacts
- Principal investigator: Rosangela Caruso, M.D., PhD — Istituto di Psichiatria. Università degli Studi di Ferrara
- Study coordinator: Luigi Grassi, M.D.
- Email: luigi.grassi@unife.it
- Phone: +39 0532 236409
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.