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

NCT03068013 | Recruiting DMC

• 1 other identifier: FAR-2015
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CALM; Depression; Demoralization; Cancer; Spirituality; Psychotherapy; Quality of Life; Anxiety; Post-Traumatic Growth

Outcome Measures

Primary Outcomes (1)

• PHQ - depression

  The Patient Health Questionnaire (PHQ-9) is a 9-item measure of depression. It is composed by nine items, reflecting Diagnostic and Statistical Manual-IV criteria for major depression. A four-point Likert scale scores from 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. A cut-off point of ≥10 is used as recommended for the screening of depression,but further analysis will be done according to other cut-off scores recommended to classify the type of depression, specifically, no depression/minimal (score 0-4), mild depression (score 5-9), moderate depression (score10-14), moderately severe depression (score 15-19), severe depression (score 20-27). For study purposes, two additional items assessing intent to cause self-harm and rating how difficult these symptoms have made it to do work, take care of things at home, or get along with other people, have been included.

  Changes in depression levels by PHQ will be assessed at baseline to assess eligibility, after 3 months and after 6 months

Secondary Outcomes (9)

• Generalized anxiety levels measured by GAD 7-generalized anxiety

  Baseline, after 3 months and after 6 months

• Death and dying distress measured DADDS-Death and dying distress scale

  Baseline, after 3 months and after 6 months

• Spiritual well being, measured by FACIT-Sp - Spiritual well-being

  Baseline, after 3 months and after 6 months

• Quality of life, measured by Quality of Life at the End of Life Cancer Scale - Quality of life

  Baseline, after 3 months and after 6 months

• Attachment security , measured by ECR-M16 - attachment security

  Baseline, after 3 months and after 6 months

Study Arms (2)

Managing Cancer Living Meaningfully

EXPERIMENTAL

Patients in the experimental group will receive the brief, individual, manualized CALM intervention, a semi-structured psychotherapy designed for patients with advanced cancer. CALM was developed based on empirical results, clinical observation and the theoretical foundations of supportive-expressive and existential approaches, as well psychodynamic and attachment theories. The sessions are delivered bimonthly over a period of 6 months. Sessions are reviewed to ensure treatment fidelity.

Behavioral: CALM

Supportive psycho-oncology intervention

ACTIVE COMPARATOR

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

Behavioral: SPI

Interventions

CALM BEHAVIORAL

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

Managing Cancer Living Meaningfully

SPI BEHAVIORAL

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.

Supportive psycho-oncology intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or more
• fluency in Italian language;
• no cognitive impairment;
• 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). -

You may not qualify if:

• communication difficulties;
• inability to commit to the required 6 sessions (i.e., too ill to participate, lack of transportation, etc.);
• actively seeing a psychotherapist, and

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead
• Princess Margaret Hospital, Canada: collaborator
• University Health Network, Toronto: collaborator

Study Sites (1)

Università di Ferrara

Ferrara, Emilia-Romagna, 44100, Italy

RECRUITING

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  BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Luigi Grassi, M.D.

  Istituto di Psichiatria. Università degli Studi di Ferrara

  STUDY CHAIR

• Rosangela Caruso, M.D., PhD

  Istituto di Psichiatria. Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Grassi, M.D.

CONTACT

+39 0532 236409; luigi.grassi@unife.it

Rosangela Caruso, M.D., PhD

CONTACT

+39 340 6053409; rosangela.caruso@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Psychiatry

Study Record Dates

• First Submitted: September 24, 2016
• First Posted: March 1, 2017
• Study Start: October 11, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)