This is a feasibility designed to investigate the feasibility of collecting QoL information from patients via digital tools. By feasibility, we mean the assessment of the uptake of the tool, the compliance to schedule and the quality of the data…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the feasibility of using digital tools to report effects of drugs
in patients on phase 1 or 2 anticancer drug trials.
Secondary outcome
To evaluate user experience of using different digital tools to self-report on
adverse events and quality of life.
Background summary
Precision cancer medicine has created a rapid evolution of clinical research,
with new types of adaptive, basket and umbrella clinical trials, amongst
others, currently being developed with the aim of optimizing the biomarker-drug
co-development process tailored to each disease setting. However, all too
often, cancer patients receive treatments which can be toxic, ineffective, or
both. Since cancer treatments often have a narrow therapeutic index, it is more
important than ever to conduct smarter clinical trials which more effectively
identify toxicities that significantly impact a patient*s quality of life so we
can truly deliver the right drug, for the right patient, at the right time,
with the right tolerability profile.
Study objective
This is a feasibility designed to investigate the feasibility of collecting QoL
information from patients via digital tools. By feasibility, we mean the
assessment of the uptake of the tool, the compliance to schedule and the
quality of the data collected. Additionally, we aim to better understand the
experience of patients and healthcare professionals in the use of digital tools
to collect clinical data on well-being and adverse events. The study will be
conducted alongside the patient*s standard care and will not interfere in their
trial-specific treatment.
Study design
All potential study participants will be seen and assessed against eligibility
criteria whilst already enrolled (cannot have started treatment) or attending
for consideration for participation in a phase 1 or 2 clinical trials. 60
patients will be enrolled in this trial. After the screening period is
complete, participants will be allocated to one of the three arms: 1. PROACT
2.0 video, 2. the PROACT 2.0 digital questionnaire, and 3. standard QoL
monitoring.
Intervention
Participants will be allocated to one of the three arms: 1. PROACT 2.0 video,
2. the PROACT 2.0 digital questionnaire, and 3. standard QoL monitoring. All
arms will last for 4 weeks.
Study burden and risks
A potential risk from this study is the potential for a data leak. To mitigate
this risk, data will be pseudonymised and linked only by a trial ID.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
1. Screening for participation in a phase 1-2 anticancer drug trials.
2. Written informed consent to participate in the study.
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 1-2 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84155.041.23 |