Ignite Creation Date:
2024-05-06 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05058196
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-17
First Post:
2021-09-16
Brief Title:
Patients Choice in the Reduction of Their Treatment in Women Over 65 Year With Breast Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Choice And Real Experience of Therapeutic deEscalation in Women Over 65 Year With Breast Cancer CARTE
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARTE
Brief Summary:
Standard treatment for women with early breast cancer HR HER2- T1N0 consists of the removal of the tumor from the breast by surgery with or without chemotherapy followed by a whole-breast radiation therapy usually one radiation treatment a day five days a week for 3 to 6 weeks
In some cases for elderly patients older than 65 years with other associated pathologies therapeutic de-escalation might be proposed in order to reduce the radiation doses received Two options can be considered
Intraoperative radiotherapy radiation is delivered in a single dose directly to the tumor bed during the surgery
Radiotherapy omission
These three treatment options whole-breast radiation therapy Intraoperative radiotherapy or -Radiotherapy omission have advantages and disadvantages Intraoperative radiotherapy allows a targeted treatment and avoids several weeks of daily radiation Radiotherapy omission prevents acute or late toxicities of the radiotherapy as well as the constraints of daily travel over a period of 3 to 6 weeks
The aim of this trial is to offer patients aged 65 and over with early breast cancer after surgery these three treatment options and to study the choice and experience of treatment by patients This study will assess the reasons that prompted patients to choose one of the three treatment options the impact of medical and personal characteristics on this choice and the experience of therapeutic de-escalation as well as its effects in particular on the course of care
This assessment will be carried out with self-administered questionnaires before and after the choice of treatment
In addition to standardize the information given to patients in order to support them in their treatment choice and promote patient involvement in treatment decision-making an encounter decision aid will be available for the patients This encounter will detail the advantages and disadvantages of the three treatment options and will help in discussions with the physicians to determine the best choice of treatment
In some cases for elderly patients older than 65 years with other associated pathologies therapeutic de-escalation might be proposed in order to reduce the radiation doses received Two options can be considered
Intraoperative radiotherapy radiation is delivered in a single dose directly to the tumor bed during the surgery
Radiotherapy omission
These three treatment options whole-breast radiation therapy Intraoperative radiotherapy or -Radiotherapy omission have advantages and disadvantages Intraoperative radiotherapy allows a targeted treatment and avoids several weeks of daily radiation Radiotherapy omission prevents acute or late toxicities of the radiotherapy as well as the constraints of daily travel over a period of 3 to 6 weeks
The aim of this trial is to offer patients aged 65 and over with early breast cancer after surgery these three treatment options and to study the choice and experience of treatment by patients This study will assess the reasons that prompted patients to choose one of the three treatment options the impact of medical and personal characteristics on this choice and the experience of therapeutic de-escalation as well as its effects in particular on the course of care
This assessment will be carried out with self-administered questionnaires before and after the choice of treatment
In addition to standardize the information given to patients in order to support them in their treatment choice and promote patient involvement in treatment decision-making an encounter decision aid will be available for the patients This encounter will detail the advantages and disadvantages of the three treatment options and will help in discussions with the physicians to determine the best choice of treatment
Detailed Description:
Current demographic trends lead to an increasing number of breast cancers among 70 women In this population adjuvant whole-breast radiation therapy WBRT after breast conserving surgery has proven its advantage on local control but does not improve survival Some experts are thus advocating WBRT omission
In this context of limited life expectancy and of frequent comorbidities therapeutic de-escalation DE might be proposed Two options of de-escalation have been considered 1 omission of adjuvant breast irradiation and 2 limiting the breast irradiated volume through a single-dose targeted intraoperative radiotherapy IORT As each of the three options standard WBRT IORT or no irradiation at all has significant harms and benefits treatment decision-making should not rely on the physicians opinion only
A recent study has shown that in this context older women desire information and have more agency and input in the decision-making process than prior literature would suggest The impact of therapeutic de-escalation on objective indicators and on patient reported outcomes must be investigated in current clinical practice as uncertainties and doubt are likely to affect the decision-making process When there is no definitive evidence to favour a treatment decision assessing the patients values and preferences appear to be of great relevance and value Thus the impact of therapeutic de-escalation on objective indicators and on patient reported outcomes PROs and experience PRE must be investigated as uncertainty is likely to affect the decision-making process We therefore propose to study the womens choice and experience of de-escalation of radiotherapy
An encounter decision aid will be used to standardize the information provided about the three options and their outcomes A prospective multicentre study using self-administered questionnaires before and after treatment decision making will then examine
the patients choice and the impact of medical and patients characteristics on this choice
the reason for the therapeutic choice from the patients point of view
the experience of DE patient-reported outcomes and its medical effects including care trajectories
This study will document the rate and reasons of DE choice among French elderly early breast cancer patients The results should facilitate the physicians reasoning at the time of treatment decision and will also help patients and their relatives become better informed of the potential consequences of their choices Developing a patient decision aid might also promote higher quality choices and shared decision-making in this context
In this context of limited life expectancy and of frequent comorbidities therapeutic de-escalation DE might be proposed Two options of de-escalation have been considered 1 omission of adjuvant breast irradiation and 2 limiting the breast irradiated volume through a single-dose targeted intraoperative radiotherapy IORT As each of the three options standard WBRT IORT or no irradiation at all has significant harms and benefits treatment decision-making should not rely on the physicians opinion only
A recent study has shown that in this context older women desire information and have more agency and input in the decision-making process than prior literature would suggest The impact of therapeutic de-escalation on objective indicators and on patient reported outcomes must be investigated in current clinical practice as uncertainties and doubt are likely to affect the decision-making process When there is no definitive evidence to favour a treatment decision assessing the patients values and preferences appear to be of great relevance and value Thus the impact of therapeutic de-escalation on objective indicators and on patient reported outcomes PROs and experience PRE must be investigated as uncertainty is likely to affect the decision-making process We therefore propose to study the womens choice and experience of de-escalation of radiotherapy
An encounter decision aid will be used to standardize the information provided about the three options and their outcomes A prospective multicentre study using self-administered questionnaires before and after treatment decision making will then examine
the patients choice and the impact of medical and patients characteristics on this choice
the reason for the therapeutic choice from the patients point of view
the experience of DE patient-reported outcomes and its medical effects including care trajectories
This study will document the rate and reasons of DE choice among French elderly early breast cancer patients The results should facilitate the physicians reasoning at the time of treatment decision and will also help patients and their relatives become better informed of the potential consequences of their choices Developing a patient decision aid might also promote higher quality choices and shared decision-making in this context
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None