Adaptive and Maladaptive Emotions in Patients With Cancer: Identification of Indicators
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 134
- 试验地点
- 6
- 主要终点
- Diagnostic mental health interview
研究概览
简要总结
Primary Objective: To identify indicators distinguishing between adaptive and maladaptive emotions in patients with cancer.
详细描述
Background of the study:
The occurrence of cancer constitutes a major stressor, leading to a wide range of emotions. Patients need support from relatives, friends and caregivers to deal with these emotions. Some patients need professional mental health care, in addition to support. Unfortunately, an accurate instrument to identify patients in need of professional mental health care is not available. This leads to important mismatches in the provision of care.
In the field of oncology, the concept of 'distress' is used to refer to emotions associated with cancer. Measurement instruments (e.g. Distress Thermometer) are used to identify patients with clinically relevant distress. This approach results in major inconsistencies.While approximately one in three patients scores above the cut-off for distress, only about one in ten patients accepts mental healthcare, while it is unclear how many need mental health care.
In the field of mental health, it is generally acknowledged that a distinction needs to be made between normal and adaptive emotions versus maladaptive and psychopathological emotions in response to a potentially traumatic event such as cancer. The concept of distress fails to make this distinction. Some patients scoring above the cut-off for distress may indeed experience maladaptive emotions. Other patients scoring above the cut-off may actually experience adaptive emotions, which facilitate coping with cancer. Therefore, in order to provide appropriate care, identification of indicators distinguishing between adaptive and maladaptive emotions in patients with cancer is an urgent research priority.
Objective of the study:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •diagnosis of a solid malignancy cancer, (i) non-metastatic disease or (ii) metastatic disease;
- •between 3 and 7 months after start of treatment with (neo)adjuvant or 1st line chemotherapy or with (neo)adjuvant or 1st line immunotherapy;
- •life expectancy of more than 3 months.
排除标准
- •age < 18;
- •insufficient command of the Dutch language;
- •severe psychopathology, other than mood or anxiety disorder (e.g. lifetime history of bipolar disorder, schizophrenia, MDD (Major Depressive Disorder) with psychotic features, schizoaffective disorders);
- •severe cognitive impairments (e.g. dementia);
- •patients with a (indication of) brain tumor or -metastases;
- •a history of severe drug or alcohol abuse within past 6 months;
- •not competent in the use of a mobile phone
- •no informed consent.
结局指标
主要结局
Diagnostic mental health interview
时间窗: Once as soon as possible after inclusion in the study and once three months after first assessment
The Composite International Diagnostic Interview (CIDI) (version 2.1) is a comprehensive, fully-structured interview for the assessment of lifetime and current (1 month recency) mental disorders, used to assess the presence of depression and anxiety disorder. In addition, we use the Four-dimensional symptom questionnaire (4DSQ) (Vier Dimensionele Klachten Lijst (4DKL) to assess adjustment disorder, with patients scoring \> 20 on Distress and without a depressive or anxiety disorder on the CIDI categorized as having an adjustment disorder. The interview is conducted in person by a well-trained researcher. Maladaptive emotions are rated as present if the patient scores positive on major depressive disorder, an anxiety disorder (panic disorder, agoraphobia without panic, specific phobia, social phobia, generalized anxiety disorder, and posttraumatic stress disorder) or adjustment disorder.
The need for professional mental health care
时间窗: Once as soon as possible after inclusion in the study and once three months after first assessment
The Distress Thermometer is a single item self-report measure of distress. Patients are asked to rate their overall distress on a visual scale from 0 (no distress) to 10 (extreme distress). The Problem List identifies problems in five domains: the practical, social, cognitive-emotional, spiritual/religious and physical domain. Patients indicate whether in the last three months they experienced a problem in these domains, using a five-point scale (ranging from 1 'no problem at all' to 5 'very much a problem'). For every domain in which patients report at least one problem, we ask whether they (a) received a referral for the problem, (b) did not receive a referral, but would have preferred a referral for the problem, (c) did not want or receive a referral for the problem, but would be willing to consider a referral in the future, or (d) did not want or receive a referral, neither in the present nor the future.
Threatening experiences
时间窗: Once as soon as possible after inclusion in the study and once three months after first assessment
The List of Threatening Experiences is a brief life events questionnaire, assessing the occurrence of 12 events (never, past year, life time)
Specific signs and symptoms as identified by oncologists and nurses
时间窗: Once as soon as possible after inclusion in the study and once three months after first assessment
In a qualitative study prior to this study, we have developed a checklist of potential signs and symptoms (e.g. a specific observation by an oncologist and nurse, such as crying or nervousness) which lead oncologists and nurses to suspect the need for professional mental health care among their patients. This checklist will be filled in by an oncologist and a nurse.
Life goals
时间窗: Once as soon as possible after inclusion in the study and once three months after first assessment
Patients are interviewed about their life goals. In the interview, they are presented with an empirically-derived list of potential life goals, in five categories: (a) achievement or work/study related goals, (b) health-related goals (we will differentiate between goals focused on disease and treatment and goals focused on improving/maintaining physical fitness, and building or maintaining a healthy lifestyle), (c) social goals, (d) psychological goals that focus on inner psychological states, and (e) leisure/pleasure related goals (cheerfulness/fun). Subsequently, patients assess to what extent they are striving to attain these goals, on a 5-point Likert scale raging from 1 'not at all' to 5 'very' (i.e. they rate the personal relevance of these life goals). The scores are used to weigh the five categories of activities (see above).
Emotional symptoms
时间窗: During two weeks, once as soon as possible after inclusion and once three months later
Prompted by Ecological Momentary Assessment (EMA), patients rate the following 15 mood states on a 7-point scale ranging from 1 'not at all' to 7 'very' (in the present study, we use 'emotional symptoms' to refer to these mood states). Emotional symptoms with a negative valence: feeling agitated, upset, irritated, listless/apathetic, down, nervous, bored, anxious, and worried. Emotional symptoms with a positive valence: satisfied, relaxed, cheerful, energetic, enthusiastic and calm. These items have been derived from the The Netherlands Study of Depression and Anxiety (NESDA) EMA diary-protocol, have sufficient with-in person variability and have been extensively used in previous studies.
Cancer-treatment-related symptoms
时间窗: During two weeks, once as soon as possible after inclusion and once three months after first assessment
Prompted by Ecological Momentary Assessment, patients rate the following six symptoms related to cancer-treatment on a 7-point scale ranging from 1 'not at all' to 7 'very': feeling tired, difficulty concentrating, nauseousness, loss of appetite, pain, and shortness of breath. These symptoms have been derived from the European Organisation For Research And Treatment Of Cancer (EORTC) item bank.
Activities related to the pursuit of life goals
时间窗: During two weeks, once as soon as possible after inclusion and once three months after first assessment
Prompted by Ecological Momentary Assessment, patients indicate whether they have been involved in the following five categories of activities: (a) work/study, (b) health-related activities (we will differentiate between activities focused on disease and treatment and activities focused on improving/maintaining physical fitness, and building or maintaining a healthy lifestyle), (c) social activities with relatives or friends, (d) intellectual and religious/spiritual activities, and (e) leisure/pleasure related activities.This question covers activities in the interval since the last assessment. The list of activities corresponds to the list of life goals (see below). Patients indicate in which activities they were involved. Combined with the patient's rating of the personal relevance of life goals (see below), this results in a rating of the involvement in specific activities related to the pursuit of personally relevant life goals.
次要结局
- Mastery(Once as soon as possible after inclusion in the study and once three months after first assessment)
- Pittsburgh Sleep Quality Index(Once as soon as possible after inclusion in the study and once three months after first assessment)
- Emotional reactivity in daily life(Once as soon as possible after inclusion in the study and once three months after first assessment)
- Social and instrumental support(Once as soon as possible after inclusion in the study and once three months after first assessment)
研究者
Prof. dr. Joost Dekker
Principal Investigator
Amsterdam UMC, location VUmc