Managing Cancer and Living Meaningfully (CALM) Adapted to Italian Cancer Care Setting
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità degli Studi di Ferrara
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 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). -
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
CALM
BehavioralCALM 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
SPI
BehavioralActive 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.
Treatment groups
171 Participants
are divided into 2 treatment groupsGroup A: Managing Cancer Living MeaningfullyExperimental treatment 1 intervention
Group B: Supportive psycho-oncology interventionActive comparator 1 intervention
Trial outcomes
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.
Time frame
Changes in depression levels by PHQ will be assessed at baseline to assess eligibility, after 3 months and after 6 monthsSecondary outcomes
1
Generalized anxiety levels measured by GAD 7-generalized anxiety
The Generalized Anxiety Disorder Questionnaire (GAD-7)is a 7-item self-report measure designed to screen the severity of GAD symptoms. Items are scored on a four-point Likert scale ranging from 0 (not at all) to 3 (nearly every day) with a total score ranging from 0 to 21. Scores up to 4 indicate absence of anxiety, scores from 5 to 9 indicate the presence of mild anxiety, scores from 10 to 15 indicate moderate anxiety. An eighth item rating how difficult these symptoms have made it to do work, take care of choirs at home, or get along with other people, has been included.
Time frame
Baseline, after 3 months and after 6 months2
Death and dying distress measured DADDS-Death and dying distress scale
The Death and Dying Distress Scale (DADDS) is a 15-item self-report measure assessing specific concerns of advanced cancer patients about end of life, feeling a burden to others and wasted opportunities. It is scored on a six-point Likert scale from 0 (no distress) to 5 (very much distress), with a total score ranging from 0 to 75, a greater score indicating higher death anxiety and distress.
Time frame
Baseline, after 3 months and after 6 months3
Spiritual well being, measured by FACIT-Sp - Spiritual well-being
The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-SP) is a 12-item self-report measure of spiritual well-being, assessing patients' sense of meaning, peace and faith. Items are scored on a five-point Likert scale from 0 (not at all) to 4 (very much), with a total score ranging from 0 to 48, with higher scores indicating higher spiritual wellbeing.
Time frame
Baseline, after 3 months and after 6 months4
Quality of life, measured by Quality of Life at the End of Life Cancer Scale - Quality of life
The Quality of Life at the End of Life-Cancer Scale (QUAL-EC)is a self- report measure of quality of life in patients near the end of life. It originally consists of five subscales: symptom control, relationship with health care providers, preparation for end of life and life completion. For this study purposes, the symptom control subscale is not included, thus only items 4-17 are used assessing the remaining subscales. Items are scored on a five-point Likert scale ranging from 1 (not at all) to 5 (completely), with a total score ranging from 14 to 70 and higher scores indicating higher quality of life.
Time frame
Baseline, after 3 months and after 6 monthsSponsors and contacts
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Università degli Studi di Ferrara
Lead sponsor
Princess Margaret Hospital, Canada
Collaborator
University Health Network, Toronto
Collaborator
Source ClinicalTrials.gov