To evaluate patient related outcomes mainly quality of life and treatment satisfaction. Side effects and therapy adherence were also evaluated because these can interfere with quality of life and treatment satisfaction.
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The proportion of patients of which HRQOL (quality of life) increases after
treatment, the proportion of patients satisfied with the treatment and the
proportion of patients with therapy adherence >=80% will be described. HRQOL
scores before and after treatment will be compared by the Mann-Whitney test.
Regressioncoefficients (confidence incidence)will describe which demografic and
diseasecharacteristics are related to a change in HRQOL. With multivariable
logistic regression we will analyze what variables are markers for (good)
therapy adherence and treatment satisfaction ( Adjusted odds ratios and
confidence interval).
Secondary outcome
not applicable
Background summary
Immunomodulating therapy for the treatment of actinic keratoses and superficial
basal cell carcinoma is a relatively new treatment. Several studies show that
Imiquimod is an effective treatment for the above mentioned indications. Less
is known about how the patient experiences this topical treatment which they
can apply at home.
Study objective
To evaluate patient related outcomes mainly quality of life and treatment
satisfaction. Side effects and therapy adherence were also evaluated because
these can interfere with quality of life and treatment satisfaction.
Study design
This is an open clinical study
Study burden and risks
Patients will visit the outpatient clinic twice. Patients are asked to fill out
questionnaires at three different moments (before-directly after treatment and
when patients visit the outcome clinic for regular planned follow-up)and a
diary (patients are asked to fill this out during treatment).
Burg. 's Jacobsplein 51
3015 CA Rotterdam
NL
Burg. 's Jacobsplein 51
3015 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Patients with actinic keratoses and/or a superficial basalcellcarcinoma, PA not neseccary
Patients are capable of treating themselve or know a person who can assist them
Patients older than 18 years
Signed informed consent
Exclusion criteria
patients mentally or physically not capable of filling out the questionnaires/diary
Patienst who are not able to understand Dutch in a way they need to to fill out the questionnaires/diary
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2008-002501-39-NL |
| CCMO | NL23594.078.08 |