1493P - The Italian version of the FAMCARE-P13 questionnaire: A validation study

Background

The FAMCARE-P13 is a PREM (Patient Reported Experience Measure) developed to assess the level of satisfaction about care received by advanced cancer patients. This self-compiled questionnaire consists of 13 items, scored on a 5-point Likert scale. The aim of this study was the cultural adaptation of the FAMCARE-P13 questionnaire-Italian version, as well as the evaluation of its psychometric properties in advanced cancer outpatients.

Methods

This monocentric study was conducted from January 2022 to November 2023. The tool has been adapted following the forward-back translation method. After a pre-test version on a sample of 30 patients, the tool was administered monthly, for six months, to outpatients with metastatic cancer. An exploratory descriptive and a confirmatory factor (CFA) analyses were conducted to evaluate the presence of underlying components, explained by the 13 items. The Comparative Fit Index and the Tucker-Lewis Index were used as goodness-of-fit indices. For assess the reliability of these indices, the residual root mean square value of approximation was used. The internal consistency was determined by calculating Cronbach's αcoefficient. To evaluate the reliability over time, a test-retest was administered to 30 patients; the global intra-class correlation coefficient (ICC) and the ICC for each item were calculated on these data. The significance level was set at. 05.

Results

The Italian translation was judged valid by translators and reviewers. A total of 319 patients have been enrolled: 59.5% of them declared themselves very satisfied, 37.9% were satisfied and 2.6% responded with the uncertain/very dissatisfied/dissatisfied to the different items. The CFA shows that the Italian version of the tool had a one-factor structure with CFI and TLI of. 92 and. 90 respectively, and RMSEA=. 10 (.12 -. 08). The satisfaction was closely related to the items of doctors' availability and caregiver participation. Cronbach's αwas >. 93 (.90 -. 95), showing satisfactory internal consistency. Even over time the test-retest analysis showed a stability, with a global ICC of 0.607 (p-value <0.0001).

Conclusions

The Italian version of the FAMCARE-P13 is a valid instrument to assess the level of satisfaction about care received by patients with advanced cancer.

Clinical trial identification

NCT04936568.

Editorial acknowledgement

Legal entity responsible for the study

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.

Funding

Research funded by Ministero della Salute (Italy).

Disclosure

E. Zecca: Other, Invited Speaker: Amgen. A.T. Caraceni: Other, Invited Speaker: Angelini, Molteni, Pfizer, Eli Lilly, Kyowa Kirin, Shionogi. All other authors have declared no conflicts of interest.