Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Patient preferences of treatment administration setting (homecare or hospital) |
Survey responses of patient experience of injections at home and compared to responses of patient experience of injections when given in hospital |
Baseline |
|
| Secondary |
Demographic characteristics of enrolled patients with GEP-NETs |
Age (years); Gender (male, female); Current employment status: full time, part time, unemployed, retired, student, homemaker, unpaid carer) |
Baseline |
|
| Secondary |
Clinical characteristics of enrolled patients with GEP-NETs |
Disease duration; Duration of homecare administration of lanreotide; Duration of hospital administration of lanreotide |
Baseline |
|
| Secondary |
Patient-reported impact on healthcare resource use |
Assessed using bespoke questionnaire a patient-reported opinion on how homecare administration compares to hospital administration (i.e. much worse / somewhat worse / about the same / somewhat better / much better) for the number of administration setting related aspects described in the protocol, as well as choosing the most applicable answer(s) where applicable. |
Baseline |
|
| Secondary |
Patient-reported impact on wider societal costs |
Assessed using bespoke questionnaire a patient-reported opinion on how homecare administration compares to hospital administration (i.e. much worse / somewhat worse / about the same / somewhat better / much better) for the number of administration setting related aspects described in the protocol, as well as choosing the most applicable answer(s) where applicable. |
Baseline |
|
| Secondary |
Patient-reported work productivity |
Assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) and bespoke questionaire |
Baseline |
|
| Secondary |
Description of patient-reported HRQoL |
Assessed using bespoke questionnaire a patient-reported opinion on how homecare administration compares to hospital administration (i.e. much worse / somewhat worse / about the same / somewhat better / much better) for the number of administration setting related aspects described in the protocol, as well as choosing the most applicable answer(s) where applicable.) |
Baseline |
|
| Secondary |
Description of patient experience of taking lanreotide in the hospital and homecare settings and reported benefits/limitations of each setting; |
Assessed using qualitative interviews which will be conducted over the telephone by an experienced qualitative interviewer. During the interview semi-structured interview guide will be used, based on guidance and feedback from a clinical expert (specialist nurse) and patient expert(s). The interviews will be primarily guided by the questions in the discussion guide; however, participants will be free to direct the conversation to topics they feel are relevant to their experience. |
1 month |
|
| Secondary |
Description of the impact of the homecare and hospital settings on HRQoL, work productivity, emotional and physical health |
Assessed using qualitative interviews which will be conducted over the telephone by an experienced qualitative interviewer. During the interview semi-structured interview guide will be used, based on guidance and feedback from a clinical expert (specialist nurse) and patient expert(s). The interviews will be primarily guided by the questions in the discussion guide; however, participants will be free to direct the conversation to topics they feel are relevant to their experience. |
1 month |
|
