Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back: a Multicentre Clinical Pilot Study

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: psychological questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: psychological questionnaires|Participants have to fulfill psychological questionnaires in different time points during medical oncological treatment|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Resilience | 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). | Every 3 months, until completion of the study, on average 2 years | 
| Personality | 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) | one measurement at Day 1 | 
| Dispositional optimism | 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. | one measurement at Day 1 | 
| Sense of coherence | 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 | one measurement at Day 1 | 
| Change in Post traumatic stress disorder | 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) | Every 3 months, until completion of the study, on average 2 years | 
| Change in Positive outcome after trauma exposure | 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 | Every 3 months, until completion of the study, on average 2 years | 
| Change in Coping flexibility | 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) | Every 3 months, until completion of the study, on average 2 years | 
| Change in Cognitive coping strategies | 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). | Every 3 months, until completion of the study, on average 2 years | 
| Change in Dispositional mindfulness | 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. | Every 3 months, until completion of the study, on average 2 years | 
| Change in Mental adjustment to cancer | 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. | Every 3 months, until completion of the study, on average 2 years | 
| Change in Social support | 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). | Every 3 months, until completion of the study, on average 2 years | 
| Change in Family resilience | 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). | Every 3 months, until completion of the study, on average 2 years | 
| Change in Illness representation | 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. | Every 3 months, until completion of the study, on average 2 years | 
| Change in patients Self-efficacy in coping with cancer | 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). | Every 3 months, until completion of the study, on average 2 years | 
| Change in Depression and anxiety | 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. | Every 3 months, until completion of the study, on average 2 years | 
| Change in Quality of life assessed by EORTC-QLQ C30 | 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). | Every 3 months, until completion of the study, on average 2 years | 
| Change in Quality of life in patients with breast cancer assessed by EORTC-QLQ BR23 | 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. | Every 3 months, until completion of the study, on average 2 years | 
| Change in Fear of cancer recurrence | 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). | Every 3 months, until completion of the study, on average 2 years | 
| Change in Positive and negative affect | 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). | Every 3 months, until completion of the study, on average 2 years | 
| Change in Distress | 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. | Every 3 months, until completion of the study, on average 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic illnesses | assessed by the presence of comorbidity (yes/no) | one measurement at Day 1 | 
| Genetic risk factors | assessed by the presence of family history of first-degree relative's breast cancer and presence of mutation (yes/no) | one measurement at Day 1 | 
| Change in Menopausal status | assessed by one of the following categories: Premenopausal Perimenopausal Postmenopausal | at Day 1 and after one year | 
| Tumor biology | assessed by indicating the following clinical characteristics: pT (mm) pN (N1,N2,N3) Histological type (ductal, lobular, other) ER (%) PR (%) Grade (I, II,III) HER2 positive or negative (FISH, SISH/CISH) | one measurement at Day 1 | 
| surgery type | assessed using one of the following categories: quadrantectomy or mastectomy, axillary dissection or sentinel lymph node biopsy | after six months | 
| Change in Performance status | assessed by using the ECOG scale | every 3 month until one year | 
| Change in Ongoing oncological therapy | assessed by indicating the type of oncological treatment using one of the following categories: chemotherapy, radiotherapy, endocrine therapy or Anti HER2 therapy | every 6 month until completion of the study, on average 2 years | 
| Change in the use of Psychotropic medication | assessed by indicating the type of the Psychotropic medication prescribed to the patient | every 3 month until completion of the study, on average 2 years | 
| Change in blood test | assessed by the following Laboratory tests: hemoglobin (gdl), leukocytes (10*3 mcl), thrombocytes (10*3 mcl), neutrophils (%), hs-CRP(number) | at Day 1 and after 12 months | 
| Age | assessed in years | one measurement at Day 1 | 
| Change in Level of education | Assessed by the highest level of education indicated by patients using one of the following categories: Primary school, Secondary school, High school, Vocational non-academic diploma, Bachelor degree, Postgraduate education (Master degree, PhD, Nba, specialization, etc.,) | At Day 1 and at up to 2 years | 
| Change in Marital status | assessed by the type of civil status indicated by patients using one of the following categories: Single, Engaged, Common-law partner, Married, Separated/divorced, Widowed | At Day 1 and up to 2 years | 
| Change in Weight | assessed by kilograms | Every 6 months, until completion of the study, on average 2 years | 
| Change in Height | assessed by centimeters | Every 6 months, until completion of the study, on average 2 years | 
| Change in Number of children | assessed by the number of children declared by patients | At Day 1 and up to 2 years | 
| Change in Employment status | assessed by occupational status indicating by patients using one of the following categories: Employed full time, Employed part time, Self-employed, Unemployed, Retired, Housewife | Every 3 months, until completion of the study, on average 2 years | 
| Change in number of sick days | assessed by the number of workdays missed because of illness or treatments declared by patients | Every 3 months, until completion of the study, on average 2 years | 
| Change in Flexible arrangements at work | assessed by asking patients if they had support from employer to obtain more flexible work arrangements | After one year and up to 2 years | 
| Return to work | assessed by asking patients if they returned to work | up to 2 years | 
| Change in monthly Income | assessed by asking patients to indicate monthly income using one of the following categories: 0-500; 501-1,000; 1,001-1,500; 1,501-2,000; 2,001-2,500; 2,501-3,000; 3,001-3,500; 3,501-4,000; 4,001-4,500; 4,501 and up | At Day 1 and up to 2 years | 
| Change in level of faith | assessed by asking patients to describe religion faith using the following categories: Ateist, Practicing believer, Non-practicing believer, | At Day 1 and up to 2 years | 
| Change in Number of professional support sessions | assessed by asking patients if they met mental health professional | Every 3 months, until completion of the study, on average 2 years | 
| Change in family's work | assessed by asking patients if their partner or someone in their family reduced their work time to take care of the patient | Every 3 months, until completion of the study, on average 2 years | 
| Change in leisure activities | assessed by asking patients to indicate if they are engaged in some activities to support well-being (e.g. culture&arts, other hobbies, mindfulness/yoga, etc) | Every 3 months, until completion of the study, on average 2 years | 
| Change in domestic help | assessed by number of days declared by patients | Every 3 months, until completion of the study, on average 2 years | 
| Change in Smoking habits | assessed by the number of smoked cigarettes | At Day 1, after 9 months and up to 2 years | 
| Change in alcohol consumption | assessed by asking patients how often they drink alcohol using one of the following categories: Never, Less than once a month, Once or twice a month, About once a week, Several times a week, Every day | At Day 1, after 9 months and up to 2 years | 
| Change in Drug use | assessed by asking patients if they use drugs and the type of drugs using one of the following categories: No, Not medically-prescribed drugs (such as tranquilizers, Ritalin or strong pain-killers), Medically-prescribed cannabis, Not medically-prescribed cannabis, Other drugs (such as MDMA or cocaine) | Every 6 months, until completion of the study, on average 2 years | 
| Change in diet habits | assessed by asking patients if they followed a specific diet and what type of diet, using one of the following categories: Low-calories, Low-carb, Mediterranean, Protein-only, Vegan, Vegeterian, Gluten-free, Dairy-free, FODMAP-free, Macrobiotic diet, Other, please specify | At Day 1, after 9 months and up to 2 years | 
| Change in Physical exercise | assessed by asking patients the type and the amount of physical excercise using one of the following categories: Moderate aerobic exercise (for example walking, cycling) in min/week; Heavy aerobic exercise (for example running, HIIT training) in min/week; Muscle training in times/week; no exercise. | Every 6 months, until completion of the study, on average 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resilience, Predictive model