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

Browse trials for

• Breast Neoplasms 12,544

Keywords

• Resilience
• Predictive model

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 660 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Lead sponsor

European Institute of Oncology is the lead sponsor of 178 studies on the registry; 113 are open to participants now.

Study population

Interventions

• Behavioralpsychological questionnaires

  Participants have to fulfill psychological questionnaires in different time points during medical oncological treatment

Primary outcomes

1. 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).

   Time frame: Every 3 months, until completion of the study, on average 2 years

2. 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)

   Time frame: one measurement at Day 1

3. 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.

   Time frame: one measurement at Day 1

4. 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

   Time frame: one measurement at Day 1

5. 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")

   Time frame: Every 3 months, until completion of the study, on average 2 years

6. 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

   Time frame: Every 3 months, until completion of the study, on average 2 years

7. 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)

   Time frame: Every 3 months, until completion of the study, on average 2 years

8. 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).

   Time frame: Every 3 months, until completion of the study, on average 2 years

9. 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.

   Time frame: Every 3 months, until completion of the study, on average 2 years

10. 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.

    Time frame: Every 3 months, until completion of the study, on average 2 years

11. 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).

    Time frame: Every 3 months, until completion of the study, on average 2 years

12. 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).

    Time frame: Every 3 months, until completion of the study, on average 2 years

13. 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.

    Time frame: Every 3 months, until completion of the study, on average 2 years

14. 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).

    Time frame: Every 3 months, until completion of the study, on average 2 years

15. 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.

    Time frame: Every 3 months, until completion of the study, on average 2 years

16. 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).

    Time frame: Every 3 months, until completion of the study, on average 2 years

17. 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.

    Time frame: Every 3 months, until completion of the study, on average 2 years

18. 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").

    Time frame: Every 3 months, until completion of the study, on average 2 years

19. 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).

    Time frame: Every 3 months, until completion of the study, on average 2 years

20. 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.

    Time frame: Every 3 months, until completion of the study, on average 2 years

Secondary outcomes

1. Chronic illnesses

   assessed by the presence of comorbidity (yes/no)

   Time frame: one measurement at Day 1

2. Genetic risk factors

   assessed by the presence of family history of first-degree relative's breast cancer and presence of mutation (yes/no)

   Time frame: one measurement at Day 1

3. Change in Menopausal status

   assessed by one of the following categories: Premenopausal Perimenopausal Postmenopausal

   Time frame: at Day 1 and after one year

4. 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)

   Time frame: one measurement at Day 1

5. surgery type

   assessed using one of the following categories: quadrantectomy or mastectomy, axillary dissection or sentinel lymph node biopsy

   Time frame: after six months

6. Change in Performance status

   assessed by using the ECOG scale

   Time frame: every 3 month until one year

7. 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

   Time frame: every 6 month until completion of the study, on average 2 years

8. Change in the use of Psychotropic medication

   assessed by indicating the type of the Psychotropic medication prescribed to the patient

   Time frame: every 3 month until completion of the study, on average 2 years

9. Change in blood test

   assessed by the following Laboratory tests: hemoglobin (gdl), leukocytes (10\*3 mcl), thrombocytes (10\*3 mcl), neutrophils (%), hs-CRP(number)

   Time frame: at Day 1 and after 12 months

10. Age

    assessed in years

    Time frame: one measurement at Day 1

11. 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.,)

    Time frame: At Day 1 and at up to 2 years

12. 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

    Time frame: At Day 1 and up to 2 years

13. Change in Weight

    assessed by kilograms

    Time frame: Every 6 months, until completion of the study, on average 2 years

14. Change in Height

    assessed by centimeters

    Time frame: Every 6 months, until completion of the study, on average 2 years

15. Change in Number of children

    assessed by the number of children declared by patients

    Time frame: At Day 1 and up to 2 years

16. 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

    Time frame: Every 3 months, until completion of the study, on average 2 years

17. Change in number of sick days

    assessed by the number of workdays missed because of illness or treatments declared by patients

    Time frame: Every 3 months, until completion of the study, on average 2 years

18. Change in Flexible arrangements at work

    assessed by asking patients if they had support from employer to obtain more flexible work arrangements

    Time frame: After one year and up to 2 years

19. Return to work

    assessed by asking patients if they returned to work

    Time frame: up to 2 years

20. 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

    Time frame: At Day 1 and up to 2 years

21. Change in level of faith

    assessed by asking patients to describe religion faith using the following categories: Ateist, Practicing believer, Non-practicing believer,

    Time frame: At Day 1 and up to 2 years

22. Change in Number of professional support sessions

    assessed by asking patients if they met mental health professional

    Time frame: Every 3 months, until completion of the study, on average 2 years

23. 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

    Time frame: Every 3 months, until completion of the study, on average 2 years

24. 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)

    Time frame: Every 3 months, until completion of the study, on average 2 years

25. Change in domestic help

    assessed by number of days declared by patients

    Time frame: Every 3 months, until completion of the study, on average 2 years

26. Change in Smoking habits

    assessed by the number of smoked cigarettes

    Time frame: At Day 1, after 9 months and up to 2 years

27. 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

    Time frame: At Day 1, after 9 months and up to 2 years

28. 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)

    Time frame: Every 6 months, until completion of the study, on average 2 years

29. 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

    Time frame: At Day 1, after 9 months and up to 2 years

30. 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.

    Time frame: Every 6 months, until completion of the study, on average 2 years

Publications

• Pettini 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 ↗