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

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ClinicalTrials.gov Identifier: NCT05095675
Recruitment Status : Recruiting
First Posted : October 27, 2021
Last Update Posted : October 27, 2021
Sponsor:
Collaborators:
Helsinki University Central Hospital
Hebrew University of Jerusalem
Fundacao Champalimaud
Foundation for Research and Technology - Hellas
Institute of Communications and Computer Systems, Athens, Greece
SINGULARLOGIC
NHG CONSULTING OY
Noona Healthcare
Information provided by (Responsible Party):
European Institute of Oncology

Tracking Information
First Submitted Date January 20, 2021
First Posted Date October 27, 2021
Last Update Posted Date October 27, 2021
Actual Study Start Date December 6, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 15, 2021)
  • Change in Resilience [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
  • Sense of coherence [ Time Frame: 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 Post traumatic stress disorder [ Time Frame: 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 Positive outcome after trauma exposure [ Time Frame: 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 Coping flexibility [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Social support [ Time Frame: 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 [ Time Frame: 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).
  • Change in Illness representation [ Time Frame: 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 patients Self-efficacy in coping with cancer [ Time Frame: 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 Depression and anxiety [ Time Frame: 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 assessed by EORTC-QLQ C30 [ Time Frame: 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 Quality of life in patients with breast cancer assessed by EORTC-QLQ BR23 [ Time Frame: 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 [ Time Frame: 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").
  • Change in Positive and negative affect [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 15, 2021)
  • Chronic illnesses [ Time Frame: one measurement at Day 1 ]
    assessed by the presence of comorbidity (yes/no)
  • Genetic risk factors [ Time Frame: one measurement at Day 1 ]
    assessed by the presence of family history of first-degree relative's breast cancer and presence of mutation (yes/no)
  • Change in Menopausal status [ Time Frame: at Day 1 and after one year ]
    assessed by one of the following categories: Premenopausal Perimenopausal Postmenopausal
  • Tumor biology [ Time Frame: one measurement at Day 1 ]
    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)
  • surgery type [ Time Frame: after six months ]
    assessed using one of the following categories: quadrantectomy or mastectomy, axillary dissection or sentinel lymph node biopsy
  • Change in Performance status [ Time Frame: every 3 month until one year ]
    assessed by using the ECOG scale
  • Change in Ongoing oncological therapy [ Time Frame: every 6 month until completion of the study, on average 2 years ]
    assessed by indicating the type of oncological treatment using one of the following categories: chemotherapy, radiotherapy, endocrine therapy or Anti HER2 therapy
  • Change in the use of Psychotropic medication [ Time Frame: every 3 month until completion of the study, on average 2 years ]
    assessed by indicating the type of the Psychotropic medication prescribed to the patient
  • Change in blood test [ Time Frame: at Day 1 and after 12 months ]
    assessed by the following Laboratory tests: hemoglobin (gdl), leukocytes (10*3 mcl), thrombocytes (10*3 mcl), neutrophils (%), hs-CRP(number)
  • Age [ Time Frame: one measurement at Day 1 ]
    assessed in years
  • Change in Level of education [ Time Frame: At Day 1 and at up to 2 years ]
    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.,)
  • Change in Marital status [ Time Frame: At Day 1 and up to 2 years ]
    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
  • Change in Weight [ Time Frame: Every 6 months, until completion of the study, on average 2 years ]
    assessed by kilograms
  • Change in Height [ Time Frame: Every 6 months, until completion of the study, on average 2 years ]
    assessed by centimeters
  • Change in Number of children [ Time Frame: At Day 1 and up to 2 years ]
    assessed by the number of children declared by patients
  • Change in Employment status [ Time Frame: Every 3 months, until completion of the study, on average 2 years ]
    assessed by occupational status indicating by patients using one of the following categories: Employed full time, Employed part time, Self-employed, Unemployed, Retired, Housewife
  • Change in number of sick days [ Time Frame: Every 3 months, until completion of the study, on average 2 years ]
    assessed by the number of workdays missed because of illness or treatments declared by patients
  • Change in Flexible arrangements at work [ Time Frame: After one year and up to 2 years ]
    assessed by asking patients if they had support from employer to obtain more flexible work arrangements
  • Return to work [ Time Frame: up to 2 years ]
    assessed by asking patients if they returned to work
  • Change in monthly Income [ Time Frame: At Day 1 and up to 2 years ]
    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
  • Change in level of faith [ Time Frame: At Day 1 and up to 2 years ]
    assessed by asking patients to describe religion faith using the following categories: Ateist, Practicing believer, Non-practicing believer,
  • Change in Number of professional support sessions [ Time Frame: Every 3 months, until completion of the study, on average 2 years ]
    assessed by asking patients if they met mental health professional
  • Change in family's work [ Time Frame: Every 3 months, until completion of the study, on average 2 years ]
    assessed by asking patients if their partner or someone in their family reduced their work time to take care of the patient
  • Change in leisure activities [ Time Frame: Every 3 months, until completion of the study, on average 2 years ]
    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)
  • Change in domestic help [ Time Frame: Every 3 months, until completion of the study, on average 2 years ]
    assessed by number of days declared by patients
  • Change in Smoking habits [ Time Frame: At Day 1, after 9 months and up to 2 years ]
    assessed by the number of smoked cigarettes
  • Change in alcohol consumption [ Time Frame: At Day 1, after 9 months and up to 2 years ]
    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
  • Change in Drug use [ Time Frame: Every 6 months, until completion of the study, on average 2 years ]
    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)
  • Change in diet habits [ Time Frame: At Day 1, after 9 months and up to 2 years ]
    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
  • Change in Physical exercise [ Time Frame: Every 6 months, until completion of the study, on average 2 years ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back
Official Title Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back: a Multicentre Clinical Pilot Study
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants are breast cancer patients with stage I-III histologically confirmed diagnosis.
Condition Breast Cancer
Intervention Behavioral: psychological questionnaires
Participants have to fulfill psychological questionnaires in different time points during medical oncological treatment
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 15, 2021)
660
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ketti Mazzocco +390257489207 ketti.mazzocco@ieo.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT05095675
Other Study ID Numbers R868/18-IEO 916
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party European Institute of Oncology
Study Sponsor European Institute of Oncology
Collaborators
  • Helsinki University Central Hospital
  • Hebrew University of Jerusalem
  • Fundacao Champalimaud
  • Foundation for Research and Technology - Hellas
  • Institute of Communications and Computer Systems, Athens, Greece
  • SINGULARLOGIC
  • NHG CONSULTING OY
  • Noona Healthcare
Investigators
Principal Investigator: Ketti Mazzocco European Institute of Oncology
PRS Account European Institute of Oncology
Verification Date October 2021