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NCT Number: NCT06590727

Psychological Well-being in Patients With Breast Cancer

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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

Primary outcomes

  1. Patients assessment

    Time frame: 1 year

    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.

Secondary outcomes

  1. Psychological distress

    Time frame: 1 year

    Investigate the risk of psychological distress of the cancer patient through the results reported in the study questionnaires

  2. Factors predictive

    Time frame: 1 year

    Quickly identify the predisposition to states of anxiety and depression through the detection of predictive factors that emerged from the evaluation of the study questionnaires administered to the cancer patient.

  3. Coping strategies

    Time frame: 1 year

    Evaluate the presence of coping strategies that the cancer patient is able to implement during the treatment process by reading the study questionnaires administered three times

  4. Identifying possible correlations

    Time frame: 1 year

    Identifying possible correlations between personological, emotional and behavioural characteristics, coping styles and possible anxious-depressive symptoms and psychological distress psychological distress;

  5. Personalised care pathway

    Time frame: 1 year

    Identify a personalized care path for the cancer patient followed in the study, based on the evaluation of the overall results of the questionnaires administered and the overall psychological evaluation that emerged.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Belella

CONTACT

[email protected]

+390630156280

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Resources Assessment to Increase pSychological dEvelopment in Breast Cancer Patients

Acronym: RAISE

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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