Psychological Well-being in Patients With Breast Cancer

NCT06590727 | Recruiting

• 1 other identifier: 6470
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Patients assessment

  Evaluate the information coming from the multidimensional evaluation (for example clinical or laboratory and psychometric evaluations) of the cancer patient during his diagnostic and therapeutic process at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

  1 year

Secondary Outcomes (5)

• Psychological distress

  1 year

• Factors predictive

  1 year

• Coping strategies

  1 year

• Identifying possible correlations

  1 year

• Personalised care pathway

  1 year

Interventions

Distress Thermometer OTHER

Enrolled patients will be given a clinical psychological interview. Then they will be given an anamnestic interview and the aforementioned questionnaires will be administered.

Also known as: Hospital Anxiety and Depression Scale, Mini Mental of Adjustment for Cancer Scale, Clinical Outcomes in Routine Assessment, Post-traumatic growth inventory

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients 18 years of age or older who have been diagnosed with breast cancer. They will be considered in a retrospectively patients who have already accessed (2022-2023) and prospectively those who will access in the future (2024-2026) the services of: UOC Senologic Surgery, UOS Integrated Therapies in Senology, UOS of Clinical Psychology FPG IRCSS to perform routine screening, psychometric evaluation, or psychological intake.

You may qualify if:

• years
• candidates for surgery
• candidates for adjuvant and/or neoadjuvant treatment

You may not qualify if:

• to 17 years old
• severe language deficits
• severe barriers
• Patients unable to understand and express informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOS Psicologia Clinica

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Daniela Belella

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Belella

CONTACT

+390630156280; daniela.belella@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: September 19, 2024
• Study Start: March 31, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: August 14, 2025

Record last verified: 2025-07

Locations

IT (1)