None listed
Conditions
Brief summary
The purpose of this sub-study is to assess the impact of radiation therapy on quality of life and patient experience for women with breast cancer. Who is it for? You may be eligible for this sub-study if you are an adult who has been diagnosed with breast cancer and is already participating in the ROSALIE study (NCT05866458 - "Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy"). Study details When you sign consent for the main ROSALIE study, you will have the option to choose to answer some questions about how the cancer diagnosis and treatment affects you. These include: * How you feel about the chance of cancer coming back * How you feel about the results of your surgery, such as how your breast looks, any pain or other feelings, effects on how you can use your arms and shoulders; and * Effects of breast cancer on your physical and mental health. The questionnaires can be completed at home on your computer, tablet or mobile phone, or paper versions can be posted to you. It will take a maximum of 20 minutes to complete all of the questionnaires. You will be asked to complete them 5 times: * When you start ROSALIE (Registration) * 6 months after registration * 1 year after registration * 3 years after registration * 5 years after registration. Your responses will remain confidential. Any concerns should be discussed with your doctor. This part of ROSALIE is optional. You can still take part in the main ROSLAIE study even if you decide not to do the questionnaires. It is hoped that the results of this study will help to inform women with breast cancer when making decisions on the best course of action with their cancer treatment.
Interventions
This substudy will assess the impact of RT omission on patient experience and outcomes including quality of life (QOL), fear of cancer recurrence, distress, decisional conflict, and decisional regret. These are of known importance to patients and relevance to patient-centred treatment decision-making.
Data will be collected from a range of questionnaires administered at Baseline, and then 6 months, 12 months, 3 years and 5 years after Registration.
PROMs will be administered via an online plat
This substudy will assess the impact of RT omission on patient experience and outcomes including quality of life (QOL), fear of cancer recurrence, distress, decisional conflict, and decisional regret. These are of known importance to patients and relevance to patient-centred treatment decision-making. Data will be collected from a range of questionnaires administered at Baseline, and then 6 months, 12 months, 3 years and 5 years after Registration. PROMs will be administered via an online platform. Participants will receive an email reminder from the system when each assessment is due. The email will contain a link to the appropriate assessment which will be accessed and completed by the participant online. Printable PROMs will be available in the event of technology problems or where online questionnaires are not permitted. It will take a maximum of 20 minutes to complete all of the questionnaires.
Sponsors
Breast Cancer Trials
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
ROSALIE study Inclusion Criteria: 1. Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type). (see AJCC TNM Cancer Staging, Appendix I). 2. Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), FNA or core needle biopsy. 3. Treated with a minimum of 8 weeks NAC, with patients with HER2+ disease receiving targeted anti-HER2+ therapy. 4. Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified. 5. Treated by BCS with complete excision of the tumour bed and axillary staging surgery (either sentinel lymph node biopsy or axillary lymph node dissection). 6. Final pathology demonstrating a pCR [defined as absence of residual invasive and in-situ breast cancer within the breast or lymph nodes (ypT0N0)]. Patients with residual DCIS (=1cm, nuclear grade 1 or 2, and with margins =3mm) are eligible. Patients with findings of fibrosis and/or histiocyte aggregates and/or other changes in the sampled lymph node are eligible. ROSALIE-PRO substudy: 1) Participants must meet all entry criteria for the BCT 2501/OCOG-2022 ROSALIE study. Data for the PRO substudy will be collected from all registered participants who consent to the PRO substudy. 2) Participants must have given informed consent using the BCT 2501/OCOG-2022 ROSALIE study PICF, which contains information about the PRO substudy. The consent must be signed and dated by the participant and investigator. 3) Participants are able (i.e. sufficiently fluent) and willing to complete the Patient Reported Outcome Measures in English or in other available languages.
Exclusion criteria
Exclusion criteria for the ROSALIE-PRO substudy as per the main ROSALIE study (NCT05866458): 1. Age less than 50 years. 2. Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4 disease). 3. Multicentric disease (i.e., breast cancer involving more than one quadrant in the same breast). 4. Prior history of ipsilateral or contralateral in-situ or invasive breast cancer. Patients with a history of LCIS are ineligible. Patients with a history of contralateral ductal carcinoma in-situ are eligible. Patients with a history of multiple breast cancers must have had genetic testing. Patients with a history of LCIS are eligible. 5. Synchronous contralateral invasive cancer. Patients with a synchronous contralateral ductal carcinoma in-situ are eligible. Patients with multiple breast cancers must have had genetic testing. 6. BRCA 1 or 2 genetic mutation carrier, or other genetic mutation present associated with increased risk of breast cancer. 7. Other previous non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers or other cancers curatively treated with no evidence of disease for >= 5 years. 8. Patients with ER > 10% disease who are not planned to have endocrine therapy initiated. 9. Patients with HER2+ disease who have not received or are not planned to receive HER2 targeted therapy. 10. ECOG performance status > 3. 11. Inability to provide informed consent. 12. Patients with isolated tumour cells within the lymph nodes ypN0(i+) are not eligible.
Outcome results
None listed