Cancer
Conditions
Brief summary
This is a 6-week, single arm, pilot study to test the study procedure, educational materials, and measurement instruments for the educational intervention in HER2 overexpressing metastatic or advanced breast cancer patients
Detailed description
Approximately 60 subjects with HER2+ metastatic or advanced breast cancer who meet the inclusion/exclusion criteria will be enrolled into the study. All subjects will receive education intervention for 6 weeks including education on Day 0, follow-up phone calls on Day 1 and Day 7, reminder phone calls before Week 3 and 6 visit and telephone hot line number.
Interventions
OTHERnon-drug intervention educational programme
educational programme
Sponsors
GlaxoSmithKline
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent; 2. Female outpatient aged 18 years or older; 3. Subjects must be about to begin their initial treatment with lapatinib + capecitabine for HER2+ metastatic or advanced breast cancer according to physician's clinical judgement as per local prescribing information 4. Subjects must be literate, be able to read, understand and write local language.
Exclusion criteria
1. Women who is participating in any other interventional clinical trials concurrently; 2. Women who is already taking or had taken lapatinib + capecitabine regimen prior to the enrollment; 3. Primary lesions that are not of breast origin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject recruitment and retention in the study | upto week 6 | Assess the feasibility of recruitment and retention of subjects into the education program |
| Adherence at Week 3 and Week 6 (MARS-6) and persistence at Week 6 | week 3 & 6 | Pilot test tools to measure subject adherence to the lapatinib + capecitabine regimen, assess persistence and describe these outcomes |
| Patient knowledge, attitude and beliefs about the regimen | Day 0, Week 3 and Week 6 | Pilot test tools to measure subject knowledge, attitudes, and beliefs about the lapatinib + capecitabine regimen and describe these outcomes |
| Acceptability of study procedures and educational materials at Week 6 | week 6 | Evaluate the implementation and acceptability of the education materials and study procedures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events and adverse events up to 6 weeks | upto week 6 | Safety during education intervention |
Countries
Hong Kong, Pakistan, Singapore, South Korea
Outcome results
None listed