Psychological Well-being in Patients With Breast Cancer
NCT06590727 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2400
Last updated 2025-08-14
Summary
Psychoncological evaluation in patients diagnosed with breast cancer is often limited to psychological distress and does not include evaluation of individual resources. This assessment could contribute to implement adherence to treatment protocols and eventual post traumatic growth. This study shows a new model of psychoncological triage by screening the risk of psychological distress and coping resources in patients with non metastatic breast cancer while waiting for surgery. The evaluation is performed at the hospital after the diagnosis and by means of psychological counseling and psychodiagnostic assessment (T0) with follow up interventions along the continuum of care.
Recruitment of the sample will take place in three different phases. It Includes time zero (T0) when patients are assessed during the pre-hospitalisation pathway. Time 1 (T1) patients are re-evaluated during the perioperative hospitalisation phase. Time 2 (T2) patients are re-evaluated after nine months at the end of treatment. As this phase is highly individualised for each patient and therefore susceptible to variation in duration and treatment modalities. Online psychometric revaluation will be possible. The link to the questionnaires will be sent to patients by e-mail and subsequently by telephone or in person contact.
Patients are evaluated by following questionnaires. Distress Thermometer (DT). Hospital Anxiety and Depression Scale (HADS). Mini Mental of Adjustment for Cancer Scale (MINIMac) and Clinical Outcomes in Routine Assessment (CORE OM) and Post Traumatic Growth Inventory
Cut off COREOM is From 10 to 15 Mild. From 15 to 20 Moderate. From 20 to 25 Mod or Severe. From 25 Severe. Scoring is from 0 is not at all and to 4 is very often/always. Reversed items 3.4. 7. 12. 19. 21. 31. 32. Higher scores correspond to greater problems.
The cut off of the distress thermometer is greater than 4. The cut off oh HADS is 7. From 0 to 7 is considered normal. A score of 8 or higher indicating probable presence of a mood disorder.
The miniMAC scale is a self-descriptive tool. The respondent on his or her own evaluates, using a four point scale to what extent a given statement applies to him or her at present. Each statement is rated on a scale of 1 (definitely not) to 4 (definitely yes), and the results available for each of the four strategies for dealing with the disease are 7-28 points. The higher the score, the greater the severity of the behaviors in the patient's struggle with cancer.
Post Traumatic Growth Inventory. Each of the 21 items falls under one of the five factors and are scored accordingly. A summation of the scores indicates the level of post-traumatic growth.
The advantage of this scale is that the categorization of scores according to the five factors are suggestive of which area of self-development is predominant in us and which area might be a little behind.
Conditions
Interventions
- OTHER
-
Distress Thermometer
Enrolled patients will be given a clinical psychological interview. Then they will be given an anamnestic interview and the aforementioned questionnaires will be administered.
Sponsors & Collaborators
-
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
lead OTHER
Principal Investigators
-
Daniela Belella · Fondazione Policlinico Universitario A. Gemelli, IRCCS
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-31
- Primary Completion
- 2028-03-31
- Completion
- 2029-07-31
Countries
- Italy
Study Locations
More Related Trials
-
Psychosocial Support in Treating Women With Recurrent Breast Cancer or Stage I, Stage II, or Stage IV Breast Cancer
NCT00416780 ·Status: COMPLETED ·Phase: NA
-
Predictive Value of the Distress Thermometer as a Predictive Screening Instrument to Detect Cancer-related Cognitive Impairment in Cancer Patients
NCT01846260 ·Status: COMPLETED
-
Effect of Counseling on Psychological Stress Amongst Women Felt to be at High Risk for Breast Cancer Development
NCT00381927 ·Status: COMPLETED
-
The Effect of Interpersonal Relationships Psychotherapy on Breast Cancer Patients
NCT06546787 ·Status: COMPLETED ·Phase: NA
-
PRO Survivorship Concerns ITA
NCT06080607 ·Status: RECRUITING
-
Five Sessions Intervention to Facilitate Adaptation to Breast Cancer
NCT02103387 ·Status: COMPLETED ·Phase: NA
-
The Distress-barometer: Face-to-face Interviews or Written Self-report Questionnaires?
NCT03357744 ·Status: COMPLETED
-
One-day Mind Programme for Women With Breast Cancer
NCT06852833 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Stress and Immunity Breast Cancer Project
NCT03578627 ·Status: COMPLETED ·Phase: NA
-
Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back
NCT05095675 ·Status: UNKNOWN
-
Life Quality and Mental State in Patients With Breast Cancer
NCT01458457 ·Status: COMPLETED ·Phase: PHASE4
-
A Novel Prosocial Online Support Group for Distressed Breast Cancer Survivors
NCT01396174 ·Status: COMPLETED ·Phase: NA
-
Online Psychological Care Program for Women Who Attend a Breast Clinic.
NCT05830461 ·Status: UNKNOWN ·Phase: NA
-
Mind Programme for Women With Breast Cancer
NCT05642897 ·Status: RECRUITING ·Phase: NA
-
Online Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors
NCT04372459 ·Status: COMPLETED ·Phase: NA
-
Clinical Stories and Psychological Experiences of Cancer Patients
NCT06109896 ·Status: NOT_YET_RECRUITING
-
Mind Programme for Women With Breast Cancer (Nationwide Coverage)
NCT06212414 ·Status: RECRUITING ·Phase: NA
-
A RCT of Psychosocial Interventions Facilitating Positive Psychological Adaptation in Breast Cancer
NCT06531135 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
NCT03770598 ·Status: COMPLETED ·Phase: NA
-
Breast Cancer Survivors: Main Physical and Psychosocial Problems After Completion of Treatment
NCT04834570 ·Status: UNKNOWN
-
Facilitating Positive Adaptation to Breast Cancer
NCT01422551 ·Status: COMPLETED ·Phase: PHASE2
-
Understanding Shared Psychobiological Pathways
NCT00245219 ·Status: COMPLETED ·Phase: NA
-
A Study of a Distress Screening and Referral Program in People With Recently Diagnosed Cancer
NCT07117461 ·Status: RECRUITING ·Phase: NA
-
Stress Management in Breast Cancer Patients
NCT01555645 ·Status: COMPLETED ·Phase: NA
-
Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress
NCT01264562 ·Status: COMPLETED