Quality of life experience after neoadjuvant chemotherapy in HER2-positive breast cancer patients: a focus group study

Outcomes for stage II and III HER2-positive breast cancer patients improved
drastically since the introduction of dual HER2-blockade. Therefor the number
of HER2-positive breast cancer survivors previously treated with chemotherapy
is increasing. Treatment with chemotherapy is known to influence quality of
life, cognitive functioning, fine motor function, fatigue, depression, and
sexual functioning.

Within the TRAIN-2 study patients were treated with two chemotherapy regimens
with unknown specific influence on health-related quality of life.
Health-related quality of life was also not an endpoint within this phase II
study. The regimens used in this trial are now widley used regimens. A
qualitative study with focus groups will give us more insights in the
differences in health-related quality of life within this population. The
outcomes of the focus groups can also directly be used to adjust EORTC
quesstionnaires for this specific group. We can used these to better measure
health related quality of life in neoadjuvant treated breast cancer patients.
The outcomes of these studies can hopefully help to make considered treatment
dicisions.

The primary objective is to identify the relevant domains of health-related
quality of life as experienced by patients who are previously treated with
neoadjuvant chemotherapy for HER2-positive breast cancer.

Secondary Objectives:
* To adjust validated quality of life questionnaires (QLQ-30 & BR-45) according
to the experience of previously treated HER2-positive breast cancer patients in
order to create a fitting tool to measure health related quality of life during
and after breast cancer treatment in a specific population.
* To validate the adjusted questionnaires.
* To evaluate quality of life experience in HER2-positive breast cancer
survivors after neoadjuvant chemotherapy with and without anthracylines.

This is an qualitative study. Potential subjects who have previously been
treated in the TRAIN-2 study will be asked to participate after permission of
their treating physician. A minimum of three focus groups will be organized to
identify domains of HRQoL after neoadjuvant treatment for HER2 positive breast
cancer. Initially, three focus groups will be organized with 6-8 participants,
which results in a sample size of 18 to 24 participants. Additional focus group
sessions will be held until no new information is gained, and data saturation
is reached (i.e., no new domains are retrieved).

The burden of participation is a maximum of 2,5 hour time investment and to
fill in the QLQ-30 and BR-45 EORTC questionnaires during the meeting.