All patients enrolled in phase I or II anticancer drug trials Cancer
Conditions
Interventions
Target population:
Patients enrolled in phase I or II anticancer drug trials.
All potential study participants will be seen and assessed against eligibility criteria whilst already enrolled (cannot ha
Sponsors
The Netherlands Cancer Institute
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients in screening for participation in a phase I or II anticancer drug trial 2. Written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Not capable of using mobile phone applications, or no carer who is willing to and able to use the applications on the participants' behalf 2. Enrolled in a phase I or II anticancer drug trial that includes a QoL questionnaire, where inclusion of an additional QoL would interfere with the study’s intended QoL measurements. This is at the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The number of patients screened failing or withdrawing from the study measured using the screen failure and withdrawal data captured in the eCRF at the end of the study 2. The proportion of patients complying with the agreed scheduled use of the digital tools measured daily using data from the PROACT tool for 28 days Adherence to agreed usage schedule of at least 75% would be considered acceptable for feasibility for assessment of the digital tools. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life measured using the EuroQol 5-level EQ-5D version (EQ-5D-5L) questionnaire completed by patients at the end of the study 2. The experience of healthcare professionals with the PROACT app measured using data collected during semi-structured interviews with healthcare professionals at the end of the study | — |
Countries
England, United Kingdom
Contacts
Public ContactDebra Joy Hall
Outcome results
None listed