Breast CancerRAISENCT06590727
Psychological Well-being in Patients With Breast Cancer
An observational study of Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Distress Thermometer
- How many people
- 2,400 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2024to 31 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years
- candidates for surgery
- candidates for adjuvant and/or neoadjuvant treatment
Who cannot join
- 0 to 17 years old
- severe language deficits
- severe barriers
- Patients unable to understand and express informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOS Psicologia Clinica
Roma, 00168
Daniela Belella, +390630156280, daniela.belella@policlinicogemelli.it
Daniela Pia Rosaria Chieffo, +390630156280, danielapiarosaria.chieffo@policlinicogemelli.it
About this study
Official title: Resources Assessment to Increase pSychological dEvelopment in Breast Cancer Patients
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.
Read more
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
- Being tested
- Distress Thermometer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distress ThermometerOther
Also called Hospital Anxiety and Depression Scale, Mini Mental of Adjustment for Cancer Scale, Clinical Outcomes in Routine Assessment, Post-traumatic growth inventory
Enrolled patients will be given a clinical psychological interview. Then they will be given an anamnestic interview and the aforementioned questionnaires will be administered.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
Psychological distress
Investigate the risk of psychological distress of the cancer patient through the results reported in the study questionnaires
Measured: 1 year
Factors predictive
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.
Measured: 1 year
Coping strategies
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
Measured: 1 year
Identifying possible correlations
Identifying possible correlations between personological, emotional and behavioural characteristics, coping styles and possible anxious-depressive symptoms and psychological distress psychological distress;
Measured: 1 year
Personalised care pathway
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start31 Mar 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniela Belella, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590727
- Sponsor's protocol ID
- 6470
- Acronym
- RAISE
- Status last verified
- Jul 2025
- First submitted
- 24 May 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resources Assessment to Increase pSychological dEvelopment in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06590727
- Acronym / sponsor ID
- RAISE / 6470
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 31 Mar 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 18 years
- candidates for surgery
- candidates for adjuvant and/or neoadjuvant treatment
Key exclusion criteria (4 listed)
- 0 to 17 years old
- severe language deficits
- severe barriers
- Patients unable to understand and express informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distress ThermometerAlso: Hospital Anxiety and Depression Scale, Mini Mental of Adjustment for Cancer Scale, Clinical Outcomes in Routine Assessment, Post-traumatic growth inventoryEnrolled patients will be given a clinical psychological interview. Then they will be given an anamnestic interview and the aforementioned questionnaires will be administered. | Other | – |
Primary outcome
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.
5 secondary outcomes
Psychological distress
Time frame: 1 year
Factors predictive
Time frame: 1 year
Coping strategies
Time frame: 1 year
Identifying possible correlations
Time frame: 1 year
Personalised care pathway
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniela Belella principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Belella (+390630156280, daniela.belella@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients assessment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.