The primary aim of this study is to identify the psychosocial determinants of stress (vulnerability) and cognitive complaints in breast cancer patients treated with adjuvant radiotherapy. The stress model of Taylor and Aspinwall will be used.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Cognitive and attention disorders and disturbances
- Breast disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Subjective cognitive complaints
Secondary outcome
n.a.
Background summary
Several studies have found cognitive impairment in subgroups of patients
treated with chemotherapy, based on data of predominantly breast cancer
patients. Studies on cognitive sequelae of radiotherapy are scarse, but show
that cognitive complaints can also occur after this treatment modality. No
correlation has been found between cognitive impairment scores en cognitive
complaints. Cognitive complaints were related to anxiety and depression scores.
Little is known about the psychosocial predictors of cognitive complaints and
the relationship with stress-vulnerability in breast cancer patients.
Study objective
The primary aim of this study is to identify the psychosocial determinants of
stress (vulnerability) and cognitive complaints in breast cancer patients
treated with adjuvant radiotherapy. The stress model of Taylor and Aspinwall
will be used.
Study design
Women with a palpable lump in the breast visiting the TweeSteden Hospital
(Tilburg) during the period May 2008 and January 2011, are asked to participate
in the study. They all complete questionnaires at baseline. Only women, who are
diagnosed with breast cancer and receive elective radiotherapy participate
further in the study. Completion of questionnaires (demographic factors,
personality factors (only at baseline), self esteem, depressive symptoms,
anxiety, fatigue, social support, perceived stress and coping) will occur
before diagnose and 3, 6 and 12 months after ending radiotherapy. Patients fill
in the questionnaires at home. Data will be analyzed with univariate regression
analyses (ANOVA, ANCOVA). With an alpha set at 0.05 and a power of .80 a sample
size of 77 is needed. A large effect size is tolerated.
Possible results: This study can provide more insight in the relationship
between a life threatening disease i.e. breast cancer, relevant psychosocial
factors, stress (vulnerability) and subjective cognitive complaints. Patients
can be provided with information relating experienced cognitive problems to
emotional distress and subsequent interventions can address a patient*s
specific stressors and promote effective coping strategies.
Study burden and risks
n.a.
Postbus 90107
5000 LA Tilburg
NL
Postbus 90107
5000 LA Tilburg
NL
Listed location countries
Age
Inclusion criteria
Women, who are for the first time diagnosed with breast cancer and receive elective radiotherapy.
Exclusion criteria
Alcohol- or drugsabuse
No Dutch speaking
Radio- or chemotherapy before
Neurological or psychiatric history
Medication that can influence cognitive functioning
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 | NL22005.028.08 |