Breast CancerBOUNCENCT05095675
Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back
An observational study of Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- psychological questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 660 participants
- Where
- 1 siteItaly
- Study dates
- 6 Dec 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants are breast cancer patients with stage I-III histologically confirmed diagnosis.
Who may be able to join
- 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
Who cannot join
- 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
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- Treatment for invasive cancer
- Treatment for any major illness in the last half year
- Pregnancy or breastfeeding at time of recruitment
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, 20141
ketti mazzocco, +390257489207, ketti.mazzocco@ieo.it
About this study
Official title: Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back: a Multicentre Clinical Pilot Study
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).
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- psychological questionnaires
- Keywords
- Resilience, Predictive model
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological questionnairesBehavioural
Participants have to fulfill psychological questionnaires in different time points during medical oncological treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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")
Measured: 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
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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").
Measured: 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).
Measured: 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.
Measured: Every 3 months, until completion of the study, on average 2 years
Secondary outcomes (30)
Chronic illnesses
assessed by the presence of comorbidity (yes/no)
Measured: 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)
Measured: one measurement at Day 1
Change in Menopausal status
assessed by one of the following categories: Premenopausal Perimenopausal Postmenopausal
Measured: 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)
Measured: one measurement at Day 1
surgery type
assessed using one of the following categories: quadrantectomy or mastectomy, axillary dissection or sentinel lymph node biopsy
Measured: after six months
Change in Performance status
assessed by using the ECOG scale
Measured: 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
Measured: 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
Measured: 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)
Measured: at Day 1 and after 12 months
Age
assessed in years
Measured: 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.,)
Measured: 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
Measured: At Day 1 and up to 2 years
Change in Weight
assessed by kilograms
Measured: Every 6 months, until completion of the study, on average 2 years
Change in Height
assessed by centimeters
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After one year and up to 2 years
Return to work
assessed by asking patients if they returned to work
Measured: 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
Measured: 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,
Measured: 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
Measured: 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
Measured: 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)
Measured: Every 3 months, until completion of the study, on average 2 years
Change in domestic help
assessed by number of days declared by patients
Measured: Every 3 months, until completion of the study, on average 2 years
Change in Smoking habits
assessed by the number of smoked cigarettes
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: Every 6 months, until completion of the study, on average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start6 Dec 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Ketti Mazzocco, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095675
- Sponsor's protocol ID
- R868/18-IEO 916
- Acronym
- BOUNCE
- Status last verified
- Jun 2023
- First submitted
- 20 Jan 2021
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karademas EC, Roziner I, Mazzocco K, Pat-Horenczyk R, Sousa B, Oliveira-Maia AJ, Stamatakos G, Kondylakis H, Kolokotroni E, Almeida S, Lemos R, Mattson J, Simos P, Poikonen-Saksela P. The illness representations-physical well-being interplay over time in breast cancer patients. Health Psychol. 2025 Aug;44(8):779-788. doi: 10.1037/hea0001499. Epub 2025 Mar 27.
PubMed 40146609Dahabre R, Bentley G, Poikonen-Saksela P, Mazzocco K, Sousa B, Pat-Horenczyk R. Can mindfulness facilitate posttraumatic growth in breast cancer patients? The mediating role of illness perceptions and positive emotions. J Health Psychol. 2024 Apr;29(5):438-451. doi: 10.1177/13591053231223484. Epub 2024 Feb 5.
PubMed 38312012Pettini G, Sanchini V, Pat-Horenczyk R, Sousa B, Masiero M, Marzorati C, Galimberti VE, Munzone E, Mattson J, Vehmanen L, Utriainen M, Roziner I, Lemos R, Frasquilho D, Cardoso F, Oliveira-Maia AJ, Kolokotroni E, Stamatakos G, Leskela RL, Haavisto I, Salonen J, Richter R, Karademas E, Poikonen-Saksela P, Mazzocco K. Predicting Effective Adaptation to Breast Cancer to Help Women BOUNCE Back: Protocol for a Multicenter Clinical Pilot Study. JMIR Res Protoc. 2022 Oct 12;11(10):e34564. doi: 10.2196/34564.
PubMed 36222801
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back: a Multicentre Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT05095675
- Acronym / sponsor ID
- BOUNCE / R868/18-IEO 916
- Conditions
- Breast Cancer
- Keywords
- Resilience, Predictive model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- 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
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are breast cancer patients with stage I-III histologically confirmed diagnosis.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychological questionnairesParticipants have to fulfill psychological questionnaires in different time points during medical oncological treatment | Behavioural | – |
Primary outcome
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.
30 secondary outcomes
Chronic illnesses
Time frame: one measurement at Day 1
Genetic risk factors
Time frame: one measurement at Day 1
Change in Menopausal status
Time frame: at Day 1 and after one year
Tumor biology
Time frame: one measurement at Day 1
surgery type
Time frame: after six months
Change in Performance status
Time frame: every 3 month until one year
Change in Ongoing oncological therapy
Time frame: every 6 month until completion of the study, on average 2 years
Change in the use of Psychotropic medication
Time frame: every 3 month until completion of the study, on average 2 years
Change in blood test
Time frame: at Day 1 and after 12 months
Age
Time frame: one measurement at Day 1
Change in Level of education
Time frame: At Day 1 and at up to 2 years
Change in Marital status
Time frame: At Day 1 and up to 2 years
Change in Weight
Time frame: Every 6 months, until completion of the study, on average 2 years
Change in Height
Time frame: Every 6 months, until completion of the study, on average 2 years
Change in Number of children
Time frame: At Day 1 and up to 2 years
Change in Employment status
Time frame: Every 3 months, until completion of the study, on average 2 years
Change in number of sick days
Time frame: Every 3 months, until completion of the study, on average 2 years
Change in Flexible arrangements at work
Time frame: After one year and up to 2 years
Return to work
Time frame: up to 2 years
Change in monthly Income
Time frame: At Day 1 and up to 2 years
Change in level of faith
Time frame: At Day 1 and up to 2 years
Change in Number of professional support sessions
Time frame: Every 3 months, until completion of the study, on average 2 years
Change in family's work
Time frame: Every 3 months, until completion of the study, on average 2 years
Change in leisure activities
Time frame: Every 3 months, until completion of the study, on average 2 years
Change in domestic help
Time frame: Every 3 months, until completion of the study, on average 2 years
Change in Smoking habits
Time frame: At Day 1, after 9 months and up to 2 years
Change in alcohol consumption
Time frame: At Day 1, after 9 months and up to 2 years
Change in Drug use
Time frame: Every 6 months, until completion of the study, on average 2 years
Change in diet habits
Time frame: At Day 1, after 9 months and up to 2 years
Change in Physical exercise
Time frame: Every 6 months, until completion of the study, on average 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Derived from this study: PubMed 40146609Karademas EC, Roziner I, Mazzocco K, Pat-Horenczyk R, Sousa B, Oliveira-Maia AJ, Stamatakos G, Kondylakis H, Kolokotroni E, Almeida S, Lemos R, Mattson J, Simos P, Poikonen-Saksela P. The illness representations-physical well-being interplay over time in breast cancer patients. Health Psychol. 2025 Aug;44(8):779-788. doi: 10.1037/hea0001499. Epub 2025 Mar 27.
- Derived from this study: PubMed 38312012Dahabre R, Bentley G, Poikonen-Saksela P, Mazzocco K, Sousa B, Pat-Horenczyk R. Can mindfulness facilitate posttraumatic growth in breast cancer patients? The mediating role of illness perceptions and positive emotions. J Health Psychol. 2024 Apr;29(5):438-451. doi: 10.1177/13591053231223484. Epub 2024 Feb 5.
- Derived from this study: PubMed 36222801Pettini G, Sanchini V, Pat-Horenczyk R, Sousa B, Masiero M, Marzorati C, Galimberti VE, Munzone E, Mattson J, Vehmanen L, Utriainen M, Roziner I, Lemos R, Frasquilho D, Cardoso F, Oliveira-Maia AJ, Kolokotroni E, Stamatakos G, Leskela RL, Haavisto I, Salonen J, Richter R, Karademas E, Poikonen-Saksela P, Mazzocco K. Predicting Effective Adaptation to Breast Cancer to Help Women BOUNCE Back: Protocol for a Multicenter Clinical Pilot Study. JMIR Res Protoc. 2022 Oct 12;11(10):e34564. doi: 10.2196/34564.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ketti Mazzocco principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ketti Mazzocco (+390257489207, ketti.mazzocco@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Resilience (time frame: Every 3 months, until completion of the study, on average 2 years). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05095675, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.