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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 171
- 试验地点
- 2
- 主要终点
- PHQ - depression
研究概览
简要总结
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.
详细描述
The study is coordinated by the Program on Psycho-Oncology and Palliative Care, University of Ferrara Northern Italy. Another centre from northern Italy will collaborate. The study is designed as a single-blinded randomized-controlled trial with two arms. Participants in the experimental group will receive the CALM intervention, while those in Control Group will receive a supportive intervention, which is usual psycho-oncology care in our settings.The primary outcome is depression. The primary endpoint is 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.The study has received approval from Ethical Committees.
Interventions:Patients in the experimental group will receive the CALM intervention, a semi-structured psychotherapy designed for patients with advanced cancer. In this Italian adaptation, CALM consists of 12 individual sessions (45-60 minutes each), instead of the original 6 sessions. The sessions are delivered bimonthly over a period of 6 months.
The intervention covers four domains: 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.
Non-manualized supportive psycho-oncology intervention (SPI):The Control group intervention includes counseling, information, crisis intervention, which is the usual care intervention provided in our center. As with CALM patients, SPI patients receive up to twelve sessions of individual therapy during a period of 6 months.
Inclusion criteria are:18 years of age or more;fluency in Italian language; absence of cognitive deficit documented in the clinical records;diagnosis of "wet" stage IIIB or IV lung cancer; any stage of pancreatic cancer, stage III or IV ovarian and fallopian tube cancers, or other stage IV gynecological cancer; and stage IV breast, genitourinary, gastrointestinal, melanoma, sarcoma, or endocrine cancers (all with an expected survival of 12-18 months); a score ≥10 at the Patient Health Questionnaire and/or ≥ 20 at the Death and Dying Distress Scale. Exclusion criteria are: language barriers hindering psychotherapy;inability to commit to the required 12 sessions; concomitant psychotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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). -
排除标准
- •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
结局指标
主要结局
PHQ - depression
时间窗: Changes in depression levels by PHQ will be assessed at baseline to assess eligibility, after 3 months and after 6 months
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.
次要结局
- 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)
- 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)
- Demoralization levels, measured by DS scale - demoralization(Baseline, after 3 months and after 6 months)
- Personal growth measured by PTGI-post-traumatic growth scale(Baseline, after 3 months and after 6 months)
- Attachment security , measured by ECR-M16 - attachment security(Baseline, after 3 months and after 6 months)
- Communication with partner measured by CCS- communication with partner(Baseline, after 3 months and after 6 months)
- Satisfaction with care, measured by CEQ - satisfaction with care(After 3 and 6 months)
研究者
Luigi Grassi
Professor and Chair of Psychiatry
Università degli Studi di Ferrara