Depression Clinical Trial
— CALM-ITOfficial title:
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
NCT number | NCT03068013 |
Other study ID # | FAR-2015 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 11, 2018 |
Est. completion date | January 2022 |
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.
Status | Recruiting |
Enrollment | 126 |
Est. completion date | January 2022 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Università di Ferrara | Ferrara | Emilia Romagna |
Lead Sponsor | Collaborator |
---|---|
Università degli Studi di Ferrara | Princess Margaret Hospital, Canada, University Health Network, Toronto |
Italy,
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* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Baseline, after 3 months and after 6 months | |
Secondary | 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. | Baseline, after 3 months and after 6 months | |
Secondary | 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. | Baseline, after 3 months and after 6 months | |
Secondary | 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. | Baseline, after 3 months and after 6 months | |
Secondary | Attachment security , measured by ECR-M16 - attachment security | The Experiences in Close Relationships Inventory Modified Short Form Version (ECR-M16), is used in its 16-item self-report form to measure the attachment style (i.e. style in relationships perceived to be important for felt security). The scale yields scores on two dimensions: avoidance and anxiety. Items are scored on a seven-point Likert scale ranging from 1 (disagree) to 7 (agree), with a total sum score ranging from 16 to 56 on each subscale. Higher scores on one or both subscale indicate higher attachment insecurity. | Baseline, after 3 months and after 6 months | |
Secondary | Personal growth measured by PTGI-post-traumatic growth scale | The Posttraumatic Growth Inventory (PTGI) is a 21-item self-report scale which measures positive psychological changes after trauma. It consists of four subscales: new possibilities, appreciation of life, relating to others and spiritual change. Items are scored on a three-point Likert scale ranging from 0 (not at all) to 2 (very much) with a total score ranging from 0 to 42. High scores indicate greater post-traumatic growth. | Baseline, after 3 months and after 6 months | |
Secondary | Communication with partner measured by CCS- communication with partner | The Couple Communication Scale (CCS) is used for participants who are married, common-law, or in a long-term relationship. The CCS is taken from the PREPARE/ENRICH Inventory, of which we used ten items concerning romantic relationship, with each item scored from 1 (strongly disagree) to 5 (strongly agree). | Baseline, after 3 months and after 6 months | |
Secondary | Satisfaction with care, measured by CEQ - satisfaction with care | Intervention and control participants complete respectively the Clinical Evaluation Questionnaire (CEQ) [19] - CALM and SPI at 3 and 6-months; a seven-item self-report questionnaire which assesses the level of mastery and insight patients have gained in time and the extent to which therapeutic sessions were perceived as helpful for patients. Experimental group patients' satisfaction will also be qualitatively assessed by inviting participants to share comments in a written form after completing CEQ questionnaire. | After 3 and 6 months | |
Secondary | Demoralization levels, measured by DS scale - demoralization | 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. | Baseline, after 3 months and after 6 months |
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