NCT06590727: RAISE

Psychological Well-being in Patients With Breast Cancer

Recruiting now Last updated 14 August 2025

What this trial tests

trial testing Distress Thermometer in Breast Cancer in 2,400 participants. Currently enrolling.

Timeline

31 March 2024

Primary endpoint
31 March 2028

31 July 2029

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	2,400
Start date	31 March 2024
Primary completion	31 March 2028
Estimated completion	31 July 2029
Sites	1 location across Italy

Drugs / interventions tested

• Distress Thermometer

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.