Outcome variable(s) | Measure(s) and data collection procedures | Data source and reporter (when applicable) |
---|---|---|
Acceptability from patient’s perspective | Acceptability—reflecting the end users’ satisfaction with the intervention—will be assessed using the 4-item Acceptability of Intervention Measure (AIM). Each item applies a 5-point Likert-type scale ranging from 1 (completely disagree) to 5 (completely agree) with higher scores indicating greater acceptability [90]. | Paper survey (pat.) |
Appropriateness from patient’s perspective | The intervention’s appropriateness, i.e., its perceived suitability to address problems within its target setting, will be assessed via the 4-item Intervention Appropriateness Measure (IAM). Each item applies a 5-point Likert-type scale ranging from 1 (completely disagree) to 5 (completely agree) with higher scores indicating greater appropriateness [90]. | Paper survey (pat.) |
Feasibility from patient’s perspective | The intervention’s perceived suitability for everyday use – will be assessed with the Feasibility of Intervention Measure (FIM). Each item applies a 5-point Likert-type scale ranging from 1 (completely disagree) to 5 (completely agree) with higher scores indicating greater feasibility [90]. | Paper survey (pat.) |
Technology acceptability | The ratio of the number of data entry days to the number of technological problems, will be a measured using data gathered via the SMILeApp. | SMILe monitoring data base (SMILe Care) |
Acceptability from CC’s perspective | Acceptability—reflecting the end users’ satisfaction with the intervention—will be assessed using the 4-item Acceptability of Intervention Measure (AIM). Each item applies a 5-point Likert-type scale ranging from 1 (completely disagree) to 5 (completely agree) with higher scores indicating greater acceptability [90]. | Paper survey (CC) |
Appropriateness from CC’s perspective | The intervention’s appropriateness, i.e., its perceived suitability to address problems within its target setting, will be assessed via the 4-item Intervention Appropriateness Measure (IAM). Each item applies a 5-point Likert-type scale ranging from 1 (completely disagree) to 5 (completely agree) with higher scores indicating greater appropriateness [90]. | Paper survey (CC) |
Feasibility from CC’s perspective | The intervention’s perceived suitability for everyday use will be assessed with the Feasibility of Intervention Measure (FIM). Each item applies a 5-point Likert-type scale ranging from 1 (completely disagree) to 5 (completely agree) with higher scores indicating greater feasibility [90]. | Paper survey (CC) |
Intervention fidelity | The gold standard measure of intervention delivery (observations/evaluations using prespecified criteria) [95] will be used: Intervention participants’ attendance as planned to face-to-face visits T0 – T8 (fully, partly or not at all) will be noted by the CC. Any deviation from the intervention protocol will be recorded in view of number, length, frequency of contacts, and delivered content. | CRF (RA) |
Implementation pathway | To explore potential implementation process barriers and facilitators as well as problems experienced in its delivery, we will conduct focus group interviews with the alloSCT team including 10–15 health care professionals (i.e., haematologists, nurses, psycho-oncologists, management), who are involved in the in-patient and follow-up care, plus 10 individual intervention patient interviews. | Individual interviews (pat.) |
Focus group interviews (health care professionals) |