The objective of this study is to assess fatigue, physical activity, psychological wellbeing and quality of life in breast cancer patients during and shortly after adjuvant chemotherapy. We will study how often en how intense the symptoms occur. We…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Changes in physical activity
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study has no predefined primary and secondary end-points. All collected
data will be analyzed after completion of the study. First we will determine
how often symptoms and complaints occur. Next we will test for associations
between the parameters and whether it is possible to define parameters that
predict outcome of fatigue and quality of life. The study is intended to be
inventory and hypothesis generating.
Secondary outcome
There are no pre-defined secundary study parameters
Background summary
Fatigue, reduced physical activity, low quality of life scores, reduced
psychological wellbeing and reduced sleep quality are symptoms en phenomenon*s
found in women treated with adjuvant chemotherapy for breast cancer. In some of
these women the symptoms mentioned remain, even long after the adjuvant
chemotherapy treatment has been finished.
Study objective
The objective of this study is to assess fatigue, physical activity,
psychological wellbeing and quality of life in breast cancer patients during
and shortly after adjuvant chemotherapy. We will study how often en how intense
the symptoms occur. We will study how symptoms are associated to each other.
Finally, we will study whether it is possible to predict which women will have
continuing problems and the possibilities of early intervention.
Study design
This is an observational study on women who (will be) treated with adjuvant
chemotherapy for breast cancer. At pre-defined intervals fatigue, quality of
life scores, psychological wellbeing and sleep quality will be measured with
validated questionnaires. Physical activity will be measured for 22 weeks using
a pedometer and a diary.
Study burden and risks
This study is observational and therefore there are no risks associated with
participation. Participants are asked to use a pedometer and keep a diary for
22 weeks. Second they will be asked to complete a questionnaire in week 0, 9,
18, 21 and 36. The completion of this questionnaire will take about 15 to 20
minutes.
Henri Dunantweg 2
8934 AD Leeuwarden
NL
Henri Dunantweg 2
8934 AD Leeuwarden
NL
Listed location countries
Age
Inclusion criteria
adjuvant chemotherapy for breast cancer
6 cycles
Exclusion criteria
expected inadequate follow-up
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 | NL27435.099.09 |