Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Current intervention as of 15/10/2018:
Phase One:
The first phase is to construct a preliminary disease outcome and health economic model of breast cancer in older women. This will be based on the rat
Sponsors
Doncaster and Bassetlaw Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/10/2018: 1. Female 2. Aged over 70 years of age at the time of diagnosis of cancer 3. Primary operable (TNM categories: T1 (Tumour 2 cm or less in greatest dimension), T2 (Tumour more than 2 cm but not more than 5 cm in greatest dimension), T3 (Tumour more than 5 cm in greatest dimension), N0 (No regional lymph node metastasis), N1 (Metastasis in movable ipsilateral axillary lymph node(s), M0 (No distant metastasis)) invasive breast cancer (core biopsy or diagnostic incision biopsy) 4. Tumour ER and Her-2 status will be available and categorised according to accepted scoring systems e.g. H score 6 or Allred score 57 for ER and for Her-2, IHC score 1-3 plus FISH testing if IHC equivocal 5. Ability to give informed consent if considering full or partial trial participation (see below) 6. Willing to complete the questionnaires for the additional trial evaluations if considering full trial participation 7. If suitable for data collection only, the patient does not need to give consent but participation in the data collection exercise should be agreed and assented to by their next of kin, friend or carer 8. Willing to complete the additional questionnaires for the additional trial evaluations relating to decision-making quality, regret and knowledge. All women in the study who are offered a choice of treatments will have the decision quality forms sent to them in both intervention and control sites at baseline, 6 week and 6 month after their treatment decision. The PET versus surgery DESI may be used for any women who are considering this treatment choice. The chemotherapy versus no chemotherapy DESI may be used for any women who are considering this treatment choice. For women who are not offered either choice, the DESI will not be used. 9. Relating only to women entered into the study by a proxy decision maker because they lack cognitive capacity: the proxy decision maker will be offered access to the DESIs as part of the normal counselling process in intervention sites (and normal counselling in control sites). These proxy decision makers will be invited to complete optional questionnaires and take part in an interview about the counselling process. Previous inclusion criteria: 1. Female 2. Aged over 70 years of age at the time of diagnosis of cancer 3. Primary operable (TNM categories: T1 (Tumour 2 cm or less in greatest dimension), T2 (Tumour more than 2 cm but not more than 5 cm in greatest dimension), T3 (Tumour more than 5 cm in greatest dimension), N0 (No regional lymph node metastasis), N1 (Metastasis in movable ipsilateral axillary lymph node(s), M0 (No distant metastasis)) invasive breast cancer (core biopsy or diagnostic incision biopsy) 4. Tumour ER and Her-2 status will be available and categorised according to accepted scoring systems e.g. H score 6 or Allred score 57 for ER and for Her-2, IHC score 1-3 plus FISH testing if IHC equivocal 5. Ability to give informed consent if considering full or partial trial participation (see below) 6. Willing to complete the questionnaires for the additional trial evaluations if considering full trial participation 7. If suitable for data collection only, the patient does not need to give consent but participation in the data collection exercise should be agreed and assented to by their next of kin, friend or carer
Exclusion criteria
Exclusion criteria: 1. Disease unsuitable for surgery e.g. inoperable or metastatic disease 2. Previous invasive breast cancer (within past 5 years) 3. There is no restriction for people who are unable to speak English. Translation of study documents and translators will be undertaken by recruiting centres if required 4. For patients considered for the PET versus surgery comparison, use of concurrent Hormone Replacement Therapy (HRT) or therapy with any other oestrogen-containing preparation is an exclusion criteria, unless treatment is discontinued for 4 weeks before the study starts 5. There is no restriction for any co-morbidity or frailty as the study aims to capture data on management and outcomes in these cases 6. Patient without capacity being considered for the data collection only arm of the study but for whom there is no consultee available
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global health status/quality of life, measured using questions 29+30 of The European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30) at 6 weeks and 6 months post-intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 15/10/2018: Measured at the time of diagnosis: 1. Comorbidity, measured using the Charlson comorbidity index 2. Frailty, measured using the Barthel Index (ADL) and instrumental activities of daily living scores (IADL) 3. Cognitive status, measured using the mini-mental state examination MMSE) 4. Quality of life, measured using the EORTC QLQ C30, EORTC breast cancer-specific quality-of-life questionnaire (BR23), EORTC quality of life questionnaire module for older people with cancer (EORTC ELD 15, EuroQol Group EQ-5D) 5. Tumour stage, grade and receptor status 6. Decision regret, measured using the Decision Regret Scale 7. Shared decision making using the CollaboRATE score 8. Patient anxiety levels using the Speilberger short-form State Anxiety Score 9. Knowledge and treatment preference, measured using a non-validated questionnaire 10. Illness perceptions after the relevant treatment decision using the Brief Illness Perceptions Questionnaire 11. Coping after the relevant treatment decision, using the Brief COPE Previous secondary outcome measures: Measured at the time of diagnosis: 1. Comorbidity, measured using the Charlson comorbidity index 2. Frailty, measured using the Barthel Index (ADL) and instrumental activities of daily living scores (IADL) 3. Cognitive status, measured using the mini-mental state examination MMSE) 4. Quality of life, measured using the EORTC QLQ C30, EORTC breast cancer-specific quality-of-life questionnaire (BR23), EORTC quality of life questionnaire module for older people with cancer (EORTC ELD 15, EuroQol Group EQ-5D) 5. Tumour stage, grade and receptor status | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactCharlene Martin
Outcome results
None listed