Table 3.
Focus group findings and their application in the design of the national hormone replacement therapy (HRT) trial
| Views of women in breast cancer support groups on a proposed trial of HRT after breast cancer | Features of the national HRT trial resulting from patient negotiation |
|---|---|
| Discussion points | Eligibility criteria |
| • Does HRT use a research priority? | • Issuing of patient information booklet 16 and specific trial information both designed with patient input |
| • Is the climate right for the trial? | • Only centres where staff agrees the rationale for the trial can recruit patients |
| • Is the trial going to give any meaningful answers? | |
| • Should women with a good prognosis be invited into a trial of HRT? | |
| Recommendations | Trial Design (Fig. 2) |
| • Review of ethical and scientific need for a trial of HRT | • No placebo arm as patients wanted to know if they were taking HRT (i.e. masking effect) |
| • Greater openness among patients and clinicians about side‐effects of breast cancer treatment and investigation of their management | • Patients informed about different types of HRT and alternatives prior to randomisation so they can make an informed choice about which preparation they would like to receive once randomized. |
| • Better interdisciplinary communication about the management of menopause‐type symptoms so patient care is centred | • Prompt access to breast cancer specialist/gynaecologist as required |
| Patients’ views of participating in the pilot HRT study | |
| Discussion points | Information and support for patients and health professionals during the trial |
| • How can informed consent be ensured? | • All cancer organizations to be informed when the trial is launched |
| • Should women with no severe symptoms be recruited to a trial (1) where the end point is survival and (2) where there is a chance they may be in a control group and therefore denied effective treatment? | • Clinicians, patients and GP principles will be updated about new studies on HRT and breast cancer and receive feedback whenever trial analyses are performed |
| • Accessible, trained, dedicated trial nurses at each recruiting centre to counsel women about the trial (at outset and during participation) | |
| Recommendations | |
| • Adequate information about the trial (i.e. treatment side‐effects, types of HRT, access to research papers) | |
| • Information about trial investigations including feedback of results | |
| • Patient support during the trial (GP and hospital‐based) |