Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back: a Multicentre Clinical Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- Change in Resilience
研究概览
简要总结
Breast cancer accounts for 28% of all cancer cases in Europe ("WHO," 2018). Coping with breast cancer is becoming an increasingly burdensome socio-economic challenge, partly due to the increasing incidence registered in the last years, which is occurring despite continuous advances in medicine. This said, mortality rate has decreased significantly as 5-year survival rate has risen from 75% to 90% ("Breast Cancer Research Foundation," 2016). For these reasons the number of cancer survivors has grown, with important effects on quality of life even years after the end of treatments.
The process of successful adaptation to breast cancer and the various accompanying stressors can be conceptually defined as the person's resilience. Resilience is a complex construct that can be defined on different levels: an individual's potential (capacity to engage in adaptive coping processes), a process (adaptive reactions to adversity), and an outcome (the final state achieved as the result of coping).
While theoretical contributions regarding resilience models in medical settings have been advanced (Deshields et al., 2016), to date no one has tested the integrated contributing role of multiple psychological, biological and functional variables in predicting the patient's ability to bounce back from the stressful life event of being diagnosed with breast cancer. Resilience is going to be measured through a data-driven method (computation of resilience index on the basis of retrospective data) and through a psychometric method (various domains of resilience through questionnaires).
There is a growing need for novel strategies to improve the understanding and the capacity to predict resilience of women to the variety of stressful experiences.
BOUNCE European Project (H2020 European Project "Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE back"; Grant Agreement Nr: 777167) will bring together modelling, medical, and social sciences experts to advance current knowledge on the dynamic nature of resilience as it relates to improved quality of life.
The broad and general objective of the BOUNCE project is to build a quantitative mathematical model of factors associated with optimal adjustment capacity to cancer. The investigators will collect biomedical status (BMS), the psychosocial status (PSS) and the functional status (FUS) of breast cancer patients that literature demonstrated to be predictive of patients' capacity to bounce back during the highly stressful treatment and recovery period following diagnosis of breast cancer. The overarching goal of the model is to understand which factors predict optimal adjustment to breast cancer and which combination of factors undermine adjustment. This would allow early identification of women at risk for which it is better to intervene through a personalised psychological support.
Funding: The BOUNCE Project "Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE back" has received funding from the European Union's Horizon 2020 research and innovation programme, Project type: H2020 - SCI-2017-CNECT-2; Project type: H2020 - SCI-2017-CNECT-2; Grant Agreement Nr: 777167.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presence of a devoted informed consent signed by the patient and the physician
- •Histologically confirmed invasive early or locally advanced operable breast cancer
- •Tumour stage I, II and III
- •Patients receiving surgery as part of the local treatment
- •Patients receiving any type of systemic treatment regardless of treatment type and/or adjuvant radiation therapy if indicated as part of the local treatment
排除标准
- •Refusal to sign informed consent
- •Presence of distant metastases
- •History of another malignancy or contralateral invasive breast cancer within the last five years except cured basal cell carcinoma of skin or carcinoma in situ of the uterine cervix
- •History of early onset (i.e., before 40 years of age) mental disorder (i.e., schizophrenia, psychosis, bipolar disorder, diagnosis of major depression) or severe neurologic disorder (i.e., neurodegenerative disorder, dementia)
- •Serious other diagnosed concomitant diseases such as clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease or cardiac arrhythmia not well controlled with medication) or myocardial infarction within the last 12 months.
- •Major surgery for a severe disease or trauma which could affect patient's psychosocial wellbeing (for example, major heart or abdominal surgery) within 4 weeks prior to study entry or lack of complete recovery from the effects of surgery
- •Treatment for invasive cancer
- •Treatment for any major illness in the last half year
- •Pregnancy or breastfeeding at time of recruitment
结局指标
主要结局
Change in Resilience
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the Connor Davidson Resilience Scale (CD-RISC). The scale consists in ten item on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time).
Personality
时间窗: one measurement at Day 1
Assessed by the Ten Item Personality Inventory (TIPI). The scale consists in 10-item (measure of the Big Five dimensions) on a 7-point Likert scale, ranging from 1(Disagree strongly) to 7 (Agree strongly)
Dispositional optimism
时间窗: one measurement at Day 1
Assessed by the Life Orientation Test-Revised (LOT-R). The scale is a 10-item scale that measures optimistic and pessimistic disposition. Respondents use a 5-point rating scale (0 = strongly disagree; 4 = strongly agree) to show how much they agree with 10 statements about positive and negative expectations.
Change in Social support
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the modified Medical Outcome Study -Social Support survey(mMOS-SS). The mMOS-SS assess the emotional and the instrumental social support. The Mini-MAC items are rated on a 4-point Likert scale ranging from "Definitely does not apply to me" (1) to "Definitely apply to me" (4).
Change in Family resilience
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the Family resilience questionnaire (F.A.R.E). The FaRE Questionnaire is designed to measure family resilience in oncological settings. The scale has 24 item on a 7-point Likert scale (from strongly agree to strongly disagree).
Sense of coherence
时间窗: one measurement at Day 1
Assessed by the Sense of Coherence (SOC) 13 item scale. The response alternatives are a semantic scale of 1 point to 7 points, where 1 and 7 indicate extreme feelings about questions (and statements) about how one's life is experienced
Change in Positive outcome after trauma exposure
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the Posttraumatic Growth Inventory (PTGI)10 item, developed to assess growth following traumatic events. The scale consists on a 6-point Likert scale
Change in Post traumatic stress disorder
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the PCL-5. The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Respondents use a 5-point Likert scale (0 = "Not at all" to 4 = "Extremely")
Change in Coping flexibility
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the Perceived ability to cope with trauma (PACT). The questionnaire has two scales that measure the perceived ability to focus on processing the trauma (trauma focus) and to focus on moving beyond the trauma (forward focus). Respondents use a 7-point scale ranging from 1 (not at all able) to 7 (extremely able)
Change in Cognitive coping strategies
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the Cognitive Emotion Regulation Questionnaire 18 items(CERQ). The questionnaire is constructed in order to identify the cognitive emotion regulation strategies used after a negative events or situations. Responsens are given on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always).
Change in Dispositional mindfulness
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the Mindful attention awareness scale (MAAS). The scale consists in 15 item (1-6 Likert scale, from 1 "almost always" to 6 "almost never" ) designed to assess open or receptive awareness of and attention to what is taking place in the present.
Change in Mental adjustment to cancer
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the mini mental adjustment to cancer (mini-MAC). The scale consists in 29 statements allowing the identification and evaluation of four types of strategies of coping with disease. The mini-MAC scale is a self-descriptive tool. The respondent use a four-point scale, to what extent a given statement applies at present.
Change in Quality of life assessed by EORTC-QLQ C30
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the European Organization for Research and Treatment of Cancer quality of life questionnaire-Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 includes 30 items that are rated on a 4-point scale that ranges from 1 "not at all" to 4 "very much". The EORTC QLQ-C30 has a global score, 5 functional scales (physical, role, emotional, cognitive and social), 3 symptoms scales (fatigue, nausea/vomiting, pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties).
Change in patients Self-efficacy in coping with cancer
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the Cancer behavior inventory-brief (CBI-B), a measure of self-efficacy for coping in cancer patients. The instrument consists of 12 items (rated 1 = not at all confident to 7 = totally confident).
Change in Positive and negative affect
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the Positive and Negative Affect Schedule-short form (PANAS-FS). The scale consists of two 5-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Change in Distress
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the Distress Thermometer (DT). The scale consists in a single-item tool using a 0 (no distress) to 10 (extreme distress)-point Likert scale resembling a thermometer. The patient rates the level of distress over the past week.
Change in Illness representation
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the Illness perception questionnaire revised (IPQ-r). The illness perceptions questionnaire measures an individual's beliefs and feelings about their illness. The scale consists in 84 items on a 5-point Likert style scale, ranging from strongly disagree to strongly agree.
Change in Depression and anxiety
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the Hospital Anxiety and Depression Scale (HADS). is a 14-item self-report measure designed to assess depression and anxiety. Respondents are asked to rate each statement in considering the previous week on a 0-4 scale that taps into frequency.
Change in Quality of life in patients with breast cancer assessed by EORTC-QLQ BR23
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23. The scale consists in 23 item on a likert scale from 1 "not at all" to 4 "very much", assessing body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss.
Change in Fear of cancer recurrence
时间窗: Every 3 months, until completion of the study, on average 2 years
Assessed by the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). The scale consists in 9 items rated on a Likert scale ranging from 0 ("not at all" or "never") to 4 ("a great deal' or "all the time").
次要结局
- Genetic risk factors(one measurement at Day 1)
- Tumor biology(one measurement at Day 1)
- Change in the use of Psychotropic medication(every 3 month until completion of the study, on average 2 years)
- Change in blood test(at Day 1 and after 12 months)
- Change in Level of education(At Day 1 and at up to 2 years)
- Change in Weight(Every 6 months, until completion of the study, on average 2 years)
- Change in monthly Income(At Day 1 and up to 2 years)
- Change in level of faith(At Day 1 and up to 2 years)
- Chronic illnesses(one measurement at Day 1)
- Change in Menopausal status(at Day 1 and after one year)
- surgery type(after six months)
- Change in Performance status(every 3 month until one year)
- Change in Ongoing oncological therapy(every 6 month until completion of the study, on average 2 years)
- Age(one measurement at Day 1)
- Change in Employment status(Every 3 months, until completion of the study, on average 2 years)
- Change in number of sick days(Every 3 months, until completion of the study, on average 2 years)
- Return to work(up to 2 years)
- Change in Number of professional support sessions(Every 3 months, until completion of the study, on average 2 years)
- Change in family's work(Every 3 months, until completion of the study, on average 2 years)
- Change in Physical exercise(Every 6 months, until completion of the study, on average 2 years)
- Change in Marital status(At Day 1 and up to 2 years)
- Change in Height(Every 6 months, until completion of the study, on average 2 years)
- Change in Number of children(At Day 1 and up to 2 years)
- Change in Flexible arrangements at work(After one year and up to 2 years)
- Change in leisure activities(Every 3 months, until completion of the study, on average 2 years)
- Change in Smoking habits(At Day 1, after 9 months and up to 2 years)
- Change in Drug use(Every 6 months, until completion of the study, on average 2 years)
- Change in diet habits(At Day 1, after 9 months and up to 2 years)
- Change in domestic help(Every 3 months, until completion of the study, on average 2 years)
- Change in alcohol consumption(At Day 1, after 9 months and up to 2 years)