Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590727
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-24
Brief Title:
Psychological Well-being in Patients With Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Resources Assessment to Increase pSychological dEvelopment in Breast Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAISE
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 oftenalways Reversed items 34 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 patients 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
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 oftenalways Reversed items 34 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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None