Managing Cancer and Living Meaningfully (CALM) Adapted to Italian Cancer Care Setting

Summary

Background: Patients with advanced cancer suffer from a variety of psycho-social symptoms that impair quality of life and may benefit from psychotherapeutic treatment. We describe here the methodology of a randomized controlled trial to test the effectiveness of a novel and brief semi-structured psychotherapeutic intervention, called Managing Cancer and Living Meaningfully (CALM), originally developed in Canada and now cross-culturally tested in Italy.

Methods/Design: The study is a single-blinded randomized controlled trial with 2 conditions: CALM intervention versus nonspecific supportive intervention (SPI) and assessments at baseline, 3 and 6 months. The coordinating site is the Program on Psycho-Oncology and Psychiatry in Palliative Care, University of Ferrara and Integrated Department of Mental Health, S. Anna University Hospital, in Ferrara, Italy. Another centre from northern and southern Italy will collaborate. Eligibility criteria include: ≥ 18 years of age; Italian fluency; no cognitive impairment; and diagnosis of advanced cancer. The intervention consists of 12 sessions , following the CALM manual and allowing for flexibility to meet individual patients' needs. It is delivered over a 6-month period and provides reflective space for patients (and their primary caregivers) to address 4 main domains: symptom management and communication with health care providers; changes in self and relations with close others; sense of meaning and purpose; and the future and mortality. The primary outcome is depression and the primary endpoint is at 6 months. Secondary outcomes include demoralization, generalized anxiety, death anxiety, spiritual well-being, quality of life, attachment security, posttraumatic growth, communication with partners, and satisfaction with clinical interactions.

Discussion: This trial is being conducted to determine the effectiveness of CALM in an Italian cancer setting. The intervention has potential cross-national relevance and, if shown to be effective, has the potential to be disseminated as a new approach in oncology to relieve distress and promote psychological well-being in patients with advanced cancer.

Conditions

• Depression
• Anxiety
• Quality of Life

Interventions

BEHAVIORAL

CALM

CALM intervention covers four domains, namely: 1) Symptom management and communication with health care providers; 2) Changes in self and relations with close others, 3) Spiritual well-being, sense of meaning and purpose, 4) Preparing for the future, sustaining hope and facing mortality

BEHAVIORAL

SPI

Active Comparator: Supportive psycho-oncology intervention Supportive psycho-oncology intervention (SPI) includes counseling, psychoeducation and crisis intervention, which is the usual care intervention provided in our centres.

Sponsors & Collaborators

• Princess Margaret Hospital, Canada

  collaborator OTHER

• University Health Network, Toronto

  collaborator OTHER

• Università degli Studi di Ferrara

  lead OTHER

Principal Investigators

• Luigi Grassi, M.D. · Istituto di Psichiatria. Università degli Studi di Ferrara

• Rosangela Caruso, M.D., PhD · Istituto di Psichiatria. Università degli Studi di Ferrara

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-11

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Italy

Study Locations