Table 1.
Summary table of planned tasks
| Title | Task 1 | Task 2 | Task 3 | Task 4 | Task 5 |
| Concept elicitation and coding | Item generation and analysis | Instrument refinement and internal validation | External validation | Application in clinical studies | |
| Aim | To elicit concepts and coding them into a thematic library. | To generate a draft version of the instrument. | To generate the final version of the instrument. | To generate data on external validity of the final instrument. | Use in prospective clinical studies. |
| Actions | Literature review. Focus groups with patients and caregivers. Opinion of oncologists and nurses, through scientific societies. Info points AIMAC (patients and caregivers). |
Wording of items. Importance analysis with patients (15 patients per geographic region). Item analysis with cognitive interviews of patients (15 patients per geographic region). |
Factor analysis. Reliability analysis (Cronbach alpha, test–retest with 118 patients). Communication of results. |
Correlation with anchors (EORTC QLQ-C30—namely Q28 and Q29 & 30; HADS) and responsiveness; with patients. Communication of results. |
Promote and perform a large scale multicentre cross-sectional clinical trial. Communication of results. |
| Psychologists involved | Yes, for focus group and coding activities. | Yes, for cognitive interviews and analysis. | No | No | No |
| Patients involved | 30 divided in three focus groups and approximately 25 for qualitative interviews. | 90 (45 for importance analysis and 45 for cognitive interviews). | 118 based on sample size estimation. | 220 based on sample size estimation. | 1000 based on gross estimation. |
| Products | Thematic library of concepts. Paper reporting the protocol. |
Pre-final instrument. Paper reporting on qualitative research outcomes of the project. |
Final instrument. Paper presenting the final instrument. |
Correlation with external anchors. Paper reporting on validation. |
Knowledge on prevalence and risk factors for FT in Italy. At least one paper describing results of the cross-sectional study. |
| Duration | 6 months | 9 months | 9 months | 12 months | 24 months |
FT, financial toxicity; HADS, Hospital Anxiety and Depression Scale.